ICMED Standard Book Final PDF

QCI-AIMEDVoluntaryinitiative
onMedicalDevices
“IndianCertification
ofMedicalDevices(ICMED)Scheme”
2nd Floor, Institution of Engineers Building

2, Bahadur Shah Zafar Marg, New Delhi – 110 002. India
Tel. : 91-11-2337 9321, 2337 8057 Fax 91-11-2337 9621
onMedicalDevices
About QCI
The Quality Council of India (QCI) is an autonomous body set up by Government
of India jointly with the leading industry associations of India, namely CII, FICCI
and ASSOCHAM, to promote quality movement in the country and establish and
operate a national accreditation structure. It is operating accreditation in various
sectors such as conformity assessment bodies offering certification, inspection,
and testing, registration of personnel and training programmes, education,
healthcare etc.
The objectives set out for QCI at the time of its inception include;
= Establish an Accreditation Structure in the country
= Provide right and unbiased information on Quality and related standards
= Spread Quality Movement in India
= Facilitate upgradation of equipment & techniques related to Quality
= Represent India’s interest in International Forums
= Help establish Brand Equity of Indian products and services
QCI’s mission is to help India achieve and sustain total quality and reliability in all
areas of life, work, environment, product and services at individual,
organizational, community and societal levels.
About AIMED
AIMED is an Umbrella Association of Indian Manufacturers of Medical Devices
covering all types of Medical Devices including Consumables, Disposables,
Equipments, Instruments, Electronics, Diagnostics and Implants. With a Primary
Membership of over 300 Manufacturers and additionally of over 200 Associate
Members representing the interest of over 700 Manufacturers of Medical
Devices to address the manufacturer’s problems. (www.aimedindia.com)
The aim behind forming AI-MED is allow the Indian Government to access a
single point of contact and provide various services to the manufacturers like
Advocacy on policy issues, Information services, Regulations for Medical
Devices, Education and Training, services, Testing Assistance and guidance for
Quality Certification (ISO, CE, GMP), Lobbying for funding for R&D from the
Government, encourage innovations from member units, Improve clinician and
patient access to the modern, innovative and reliable Medical Device
technologies through organizing and supporting Meeting, Seminars, Symposia,
Exhibitions and Demonstrations and also, to promote global harmonization and
respect for the Indian Device Industry.
Introduction
0.1 The Quality Council of India (QCI), India’s apex quality facilitation and national
accreditation body, and the Association of Indian Medical Device Industry (AIMED),
an association of medical device industry in India, signed an MoU on 30 October 2014 to
develop and operate voluntary certification programme(s) for Medical Devices in order to
enable medical device industry to demonstrate adherence to the best international
standards and enhance its credibility in the world market. The initiative would be
operated on a non-profit but self-sustaining basis.
0.2 While QCI and AIMED are the joint Scheme owners, the governing structure of the
initiative is under a multi stakeholder Steering Committee supported by a Technical
Committee to define the technical criteria for certification and advise on any technical
issues and a Certification Committee to define the rules for auditing and certification and
competence criteria for auditors and advise on any certification related issues.
0.3 The certification scheme would have a defined consensus based technical criteria laid
down for the medical devices which would be evaluated by competent third party
certification bodies. The Certification Bodies in turn would be accredited by the National
Accreditation Board for Certification Bodies (NABCB), which is part of the
international system of equivalence of accreditations and certifications, as per
appropriate international standards. This would facilitate international acceptance of the
certifications under the Scheme.
0.4 The “Indian Certification of Medical Devices (ICMED) Scheme” as it is being

christened, envisages three levels of certification:
1. ICMED 9000 Certification which is as per requirements of ISO 9001 read with
additional requirements prescribed under the Scheme
2. ICMED 13485 which is as per requirements of ISO 13485 read with additional
requirements prescribed under the Scheme
3. Certification of medical devices as per specifications developed by the National

Health Systems Resource Centre (NHSRC) of the Ministry of Health & Family
Welfare in addition to the requirements of the above levels – this level is still under
development
Issue 1 | March 2016 1
This would ensure that the medical device industry follows the well accepted international
standards and more.
0.5 The National Health Systems Resource Centre, under the Ministry of Health & Family
Welfare, Govt. of India, which is a WHO Collaborating Centre for Priority Medical
Devices & Health Technology Policy, has been providing technical support for the
development of the Scheme and continues to remain engaged in its implementation.
0.6 It is expected that this Scheme will not only be useful for the medical devices
manufacturing industry to benchmark itself with quality certifications but will also provide
the consumer/users with medical devices produced in a quality certified manufacturing
facility.
2
TABLE OF CONTENT
Sl No. Description Page No.
1. Governing Structure----------------------------------------------------------- 5
2. Composition of Steering Committee-------------------------------------- 9
3. Composition of Technical Committee------------------------------------ 11
4. Composition of Certification Committee ---------------------------------12
5. Technical Criteria for Certification of

Medical Devices – ICMED 9000 ----------------------------------------- 13
6. Technical Criteria for Certification of

Medical Devices – ICMED 13485 --------------------------------------- 35
7. Essential Requirement Check Sheet ----------------------------------- 60
8. Provisional Approval of Certification Bodies -------------------------- 83
9 Requirement for Certification Bodies ----------------------------------- 93
10. Certification Process ------------------------------------------------------- 123
3
4
QCI – AIMED Voluntary Initiative on Medical Devices
GOVERNING STRUCTURE
1. OBJECTIVE
The objective of this document is to provide guidance to the Scheme Owner on the
establishment of the governing structure which would be required for setting up and operating
the Certification Scheme(s) {also referred to as ‘the Scheme(s)}’ under the QCI – AIMED
Voluntary Initiative on Medical Devices
2. SCOPE
2.1.1 This document describes the governing structure of the Voluntary Certification
Scheme(s) and the roles and responsibilities of various committees and organizations
involved in establishing and operating the Scheme(s).
2.1.2 This document draws upon the guidance provided in the international standard ISO/IEC
17067:2013 “Conformity assessment — Fundamentals of Product Certification and
guidelines for product certification schemes”.
3. GOVERNING STRUCTURE
3.1 The Scheme shall have a multi-stakeholder committee – a Steering Committee at the
apex level with the secretariat being held by the QCI..
3.2 The Steering Committee shall be supported by a Technical Committee and a

Certification Committee.
3.3 The Technical and the Certification committees shall be represented by a variety of
stakeholders and experts in the related technical areas and having knowledge of
conformity assessment.
5
4. COMPOSITION AND TERMS OF REFERENCE OF COMMITTEES
4.1 General Principles: In the appointment of various committees, the following general
principles should be kept in mind:
4.1.1 Representation of a balance of interests in the Steering Committee such

that no single interest predominates. While nominating representatives for
technical/certification committee, predominantly experts from relevant
organizations shall be ensured.
4.1.2 Key interests should include representatives of regulatory/standards bodies

or other governmental agencies, representatives of user associations,
industry associations, accreditation body and certification bodies (subject to
availability), test laboratories, academic/research bodies, voluntary
consumer organisations and representatives of non-governmental
organizations working in the related areas.
4.1.3 The technical committee may have additional representations from persons
competent in medical devices sector.
4.1.4 The certification committee may have additional representation from experts
who have understanding of conformity assessment.
4.1.5 Representation to individual experts should be given exercising due care in

their selection.
4.1.6 It is desirable to invite organizations to nominate Principal and Alternate

members in the interest of higher attendance and continuity.
4.2 Steering Committee: It shall comprise of Government(s), regulatory bodies, medical

device industry bodies, export promotion bodies, research/academic bodies,
accreditation bodies, testing laboratories, certification bodies, NGOs, voluntary
organisations, trade associations and or any other Technical expert(s) as invitees for
specific meetings, as identified by the secretariat. It shall be the final decision making
body for the initiative.
4.1.7 SC may coopt any other members.
4.1.8 Quorum - The presence in person, at a meeting of the Steering Committee

(SC) of the member representatives of at least 50% members of the SC
shall constitute a quorum for a meeting.
6
4.1.9 Terms of reference - The SC is responsible for:
4.1.9.1 Overall development, modification and supervision of the initiative and any
Scheme(s) devised under it
4.1.9.2 Receiving recommendations of Technical/Certification Committees and

deciding on them
4.1.9.3 Constituting any other committees, as needed
4.1.10 Meetings - The SC shall meet at least once every year.
4.2 Technical Committee (TC): It shall comprise of experts in technical matters and standards
in medical device sector drawn from Government(s), regulatory bodies, industry bodies,
export promotion bodies, research/academic institutions, standards body, accreditation
bodies, testing laboratories, certification bodies, NGOs, voluntary organisations, trade
associations, and or any other Technical expert(s) as invitees for specific meetings, as
identified by the secretariat.
4.2.1 TC may coopt any other members subject to reporting to SC.
4.2.2 Quorum - The presence in person, at a meeting of the Technical Committee (TC)
of the member representatives of at least 50% members of the TC shall
constitute a quorum for a meeting.
4.2.3 Terms of reference - The TC is responsible for;
4.2.3.1 Developing and maintaining any standards or technical documents needed for
the Scheme(s) developed under the initiative
4.2.3.2 Defining the certification criteria, and
4.2.3.3 Resolving any related issues;
4.2.4 Meetings - The TC shall meet at least once every year.
4.3 Certification Committee (CC): It shall comprise of experts from organizations as

mentioned in the Technical Committee with greater representation to accreditation/
certification bodies having insight into certification processes.
7
CC may coopt any other members.
4.3.1 Quorum - The presence in person, at a meeting of the Certification Committee

(CC) of the member representatives of at least 50% members of the CC shall
constitute a quorum for a meeting.
4.3.2 Terms of reference - The CC is responsible for;
4.3.2.1 Developing, maintaining and revising as appropriate the certification process
4.3.2.2 Developing, maintaining and revising as appropriate the requirements for

Certification bodies for the operation of the Scheme(s)
4.3.2.3 Developing guidance document to assist industry to apply for Certification
4.3.2.4 Designing the Certification Marks, if any
4.3.2.5 Developing, maintaining and revising as appropriate the rules for the use of
Certification mark or logo and
4.3.2.6 Resolving any issue relating to certification
Meetings - The CC shall meet at least once every year.
*****
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Steering Committee for QCI – AIMED Voluntary Initiative on
Medical Devices
COMPOSITION
Chairman
Dr. M. K. Bhan Former Secretary, Dept. of Biotechnology
Members Representing
Mr. Rajiv Nath Association of Indian Medical Device Industry
Dr. Bhuvaneshwar (AIMED)
Mr. P.K. Sharma
Secretary Department of Health and Family Welfare
Mr. Mayanak Krishna Engineering Export Promotion Council (EEPC)
Dr. Ganesh K Mani Association of Healthcare Providers (India)
Director General Bureau of Indian Standards
Dr. Dinesh Kalyansundram Centre of Biomedical Engineering IIT, Delhi
Mr. Prashant Kumar Department of Electronics & Information
Technology
Secretary Ministry of Micro. Small & Medium Enterprises
Sh. Sudhanshu Pandey Department of Commerce, Ministry of Commerce
& Industry
Sh. D. S. Rawat The Associated Chambers of Commerce and
Sh. Karanveer Singh Industry of India
Sh. Bharat Jaiswal
Dr. K. K. Agarwal Indian Medical Association (IMA)
Dr. R. N. Tandon
Chairman Consumer Coordination Council
Ms. Elizabeth Jose Confederation of Indian Industry
Ms. Kirti Arora
Ms. Sumati Randeo
Sh. Anil Relia National Accreditation Board for Testing and
Ms. Poonam Bajaj Calibration Laboratories (NABL)
Dr. Sanjiv Kumar National Health Systems Resource Centre
Dr. Jitendra Kumar Sharma (NHSRC)

Sh. Tanmoy Bose Federation of Indian Chambers of Commerce &
Industry
9
Sh. Sashi Nath Mishra Association of Certification Bodies in India (ACBI)
Dr. G. N. Singh Central Drugs Standard Control Organization
Sh. Somnath Basu
Dr. K. K. Kalra National Accreditation Board for Hospitals &

Dr. Gayatri V Mahindroo Healthcare
Secretary Ministry of Chemical & Fertilizers, Dept. of Pharma
Dr. R. P. Singh Quality Council of India
Sh. Anil Jauhri National Accreditation Board for Certification
Sh. Mirtunjay Jena Bodies
Secretariat
Mr. R. D. Khatri Quality Council of India
Dr. Jaishree Kasliwal Quality Council of India
10
Technical Committee for QCI – AIMED Voluntary Initiative on
Medical Devices
COMPOSITION
Chairman
Mr. Rajiv Nath Association of Indian Medical Device Industry (AIMED)
Dr. Ganesh K. Mani Association of Healthcare Providers (India)
Mr. PK Sharma Association of Indian Medical Device Industry
(AIMED)
Mr. D K Agarwal Bureau of India Standards
Mr. Sempal
Mr. Somnath Basu Central Drugs Standard Control Organization
Dr. Dinesh Kalyanasundaram Centre for Biomedical Engineering Indian Institute of
Technology, Delhi
Mr. Pankaj Bhatia Confederation of Indian Industry
Ms. Sumati Randeo
Ms. Kirti Arora
Ms. Pallavi Saha Engineering Export Promotion Council
Mr. Mayank Krishna (EEPC)
Dr. K .K. Agrawal Indian Medical Association
(IMA) Dr. R.N. Tandon
Dr. Jitendra Kumar Sharma National Health Systems Resource Centre Mr.
Mohammad Ameel (NHSRC)
Shri Anil Jauhri National Accreditation Board for Certification Bodies
Mr. M. Jena
Dr. B.K. Rao The Associated Chambers of Commerce and
Industry
Mr. Karanveer Singh of India
Secretariat
Mr. R D Khatri Quality Council of India, New Delhi
Dr. Jaishree Kasliwal Quality Council of India, New Delhi
11
Certification Committee for QCI – AIMED Voluntary Initiative
on Medical Devices
COMPOSITION
CHAIR
Sh. B. Venkataram Former Secretary GeneralQuality Council of India
MEMBER
Sh. K. Doraiswamy Association of Certification Bodies in India (ACBI)
Sh. Jibu Mathew
Sh. Gurbux Singh
Sh. P. K. Sharma Association of Indian Medical Device Industry
Sh. A Manickam (AIMED)
Sh. D. K. Aggarwal Bureau of Indian Standards
Sh. G. N. Singh Central Drugs Standard Control Organization
Sh. Anupam Kaul Confederation of Indian Industry
Ms. Sumati Randeo
Ms. Kriti Arora
Dr. K. K. Agarwal Indian Medical Association (IMA)
Dr. R. N. Tandon
Sh. Anil Relia National Accreditation Board for Testing and
Ms. Poonam Bajaj Calibration Laboratories (NABL)
Dr. Sanjiv Kumar National Health Systems Resource Centre
Dr. Jitendra Kumar Sharma (NHSRC)
Sh. Vivek Seigell PHD Chamber of Commerce and Industry
Mr. Sameer Ahuja
Sh. Anil Jauhri National Accreditation Board for Certification
Sh. Mirtunjay Jena Bodies (NABCB)
Secretariat
Mr. R. D. Khatri (Expert) Quality Council of India
12
ICMED 9000
QCI – AIMED Voluntary Initiative on

Medical Devices
Indian Certification of Medical Devices

ICMED (Scheme)
Technical Criteria for Certification of

Medical Devices – ICMED 9000
Copyright © 2016 by Quality Council of India. All rights reserved. No part of this
publication shall be reproduced or distributed in any form or by any means, or stored in
a data base or retrieval system, without the prior permission of the publisher. Issued on
behalf of the QCI – AIMED Voluntary Initiative on Medical Devices Steering Committee.

Medical Devices
COMPOSITION
Chairman
Mr. PK Sharma Association of Indian Medical Device Industry (AIMED)
Association of Certification bodies Of India
Mr. Sempal
Technology, Delhi
Ms. Sumati Randeo
Ms. Kirti Arora
Ms. Pallavi Saha Engineering Export Promotion Council (EEPC)
Mr. Mayank Krishna
Dr. K .K. Agrawal Indian Medical Association (IMA)
Dr. R.N. Tandon
Dr. Jitendra Kumar Sharma National Health Systems Resource Centre (NHSRC)
Mr. Mohammad Ameel
Mr. M. Jena
Dr. B.K. Rao The Associated Chambers of Commerce and Industry

of India
Mr. Karanveer Singh
Member – Secretary

TABLE OF CONTENTS
Technical Committee for QCI – AIMED

1 Scope ....................................................................................................... 17
1.3 Text in Italic is in addition to the requirement ISO 9001: 2008 ........... 17
1.4 Application.......................................................................................... 17
2. References .............................................................................................. 17
3. Terms and definitions ............................................................................... 18
4. Quality management systems .................................................................. 18
Corresponding Clause of ISO 9001: 2008 ................................................ 18
4.1 General requirements ...................................................................... 18
4.2 Quality Management System processes shall be appropriate to the
needs of the organization ................................................................ 18
4.2.1 The organization shall determine the process components ............ 18
4.3 Documentation requirements .......................................................... 19
4.3.1 The organization shall have following minimum documents: .......... 19
4.3.2 Control of records ........................................................................... 19
5. Management responsibility and commitment ...................................... 20
6. Resource management .......................................................................... 20
6.1 Organization shall have appropriate and adequate
human resources ............................................................................ 21
6.2. Organization shall have defined & documented policy
and procedure for training the personnel ........................................ 21
6.3 Infrastructure ................................................................................... 21
6.3.1 The organization has appropriate infrastructure to achieve
quality product................................................................................. 21
6.3.2 The organization shall maintain an environment that
supports product quality .................................................................. 22
6.3.3 Resources (manmade or natural) required to maintain appropriate
environment shall be available in right quality & quantity ................ 22

7. Product realization ................................................................................. 23
7.1 Planning of product realization ........................................................ 23
7.1.1 Organization shall plan for all the phases of product realization ..... 23
7.1.2 Organization shall established criteria for product acceptance ....... 23
7.1.3 Product realization shall meet intended and implied requirements . 24
7.1.4 The manufacturing plan incorporate product quality & safety ......... 24
7.2 Customer-related processes ........................................................... 25
7.2.1 Customer communication ............................................................... 25
7.3 Traceability, labelling, Cleaning and/ or sterilization
for products shall be ensured .......................................................... 25
7.3.1 Traceability...................................................................................... 25
7.3.2 Labelling.......................................................................................... 25
7.3.3. Cleaning and/ or Sterilization .......................................................... 25
7.4 Operational Life Cycle Management ............................................... 26
7.4.1 Organization shall ensure consistency in product characteristics .... 26
7.4.2 Installation procedures shall be determined by the organization ..... 26
7.4.3 Organization shall maintain after sale documents ........................... 26
7.4.4. Non-conformity after dispatch and maintenance
procedures shall be determined by the organization ....................... 26
7.4.5 The organization shall arrange for post-production requirements ... 27
7.5 Purchase ......................................................................................... 27
7.5.1 Organization shall have a procurement system that supports product
quality ............................................................................................. 27
8. Responsibility of Management – Measurement,
Analysis and Improvement .................................................................... 27
8.1 Organization shall be led by a management which promotes
quality in products and consistency in processes ........................... 27
number of audits ............................................................................. 28
8.3 Organization shall ensure product safety, reliability and credibility .. 28
8.4 Assessment and improvement in the quality management system .. 28
Bibliography ........................................................................................... 30
Amendment Sheet .................................................................................. 32

1 Scope
1.1 This document specifies the requirements for a quality management systems for
medical device industry which
a) needs to demonstrate its ability to consistently provide medical devices that

meet customer and applicable statutory and regulatory requirements, and
b) aims to enhance customer satisfaction through the effective application of the

system, including processes for continual improvement of the system and the
assurance of conformity to customer and applicable statutory and regulatory
requirements.
1.2 The requirements prescribed in this document shall be read with the requirements
prescribed in ISO 9001:2008.
1.3 Text in Italic is in addition to the requirement ISO 9001: 2008
1.4 Application
All requirements of this document are generic and are intended to be applicable to
all organizations, regardless of type, size and product provided.
Where any requirement(s) of this document cannot be applied due to the nature of
an organization and its products, this can be considered for exclusion.
If any requirement(s) of this document is (are) not applicable due to the nature of the
medical device(s) for which the quality management system is applied, the
organization does not need to include such a requirement(s) in its quality
management system and appropriate justification shall be recorded, provided such
exclusions do not affect the organization's ability, or responsibility, to provide
product that meets customer and applicable statutory and regulatory requirements.
2. References
The following referenced documents are necessary for the application of this document:
a) ISO 9000, Quality management systems — Fundamentals and vocabulary
b) ISO 9001:2008 Quality Management System - Requirements

3. Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 9000 and ISO
9001: 2008 apply. Throughout the text of this document, wherever the term “product”
occurs, it can also mean “service”.
Corresponding
4. Quality management systems Clause of ISO
9001: 2008
4.1 General requirements
a) the medical devices manufacturer shall have an established and
documented system for implementation and maintenance of a 4.1
quality management system;
b) the system includes identification of indicators to measure the
5.4.1/5.6
effectiveness of the quality management system;
c) the periodicity of measuring of these indicators is defined and
5.6
documented;
d) the processes required for the implementation of the quality
4.1
management system are identified and documented.
4.2 Quality Management System processes shall be appropriate to the needs of the
organization
a) the organization shall have an established system to identify all the
4.1
processes, their sequences, results, and interactions;
b) there shall be defined criteria to measure the compliance and
4.1
effectiveness of all the processes;
c) there shall be a system to measure the adequacy of inputs required
4.1
for the implementation of all the processes;
d) there shall be a system to evaluate and improve the processes
8.4/8.5
based on measurement of defined indicators.
4.2.1 The organization shall determine the process components
a) the organization shall determine the time line for completion of each
4.1
process;
b) there shall be a system to track any delay of time period in the
4.1
completion of processes;
c) there shall be a system within the organization to measure the
correctness of those processes of sub-parts of a process that the 4.1
organization outsources from agencies external to the organization;
d) the various components of all processes with the organization shall
4.1
be defined and documented;
e) the organization shall identify individuals responsible for all the 5.5

processes including management representative (M.R.);
f) all the processes required for manufacturing, identification, storing,
pre-market authorization, sale, installation, maintenance, repair and 7.1
disposal shall be documented for every product.
4.3 Documentation requirements
4.3.1 The organization shall have following minimum documents:
a) a quality manual which has defined scope, exclusions (if any) and
4.2.2
procedures covering all operations of the organization;
b) defined quality policy and quality objectives; 4.2.1 /5.3 /5.4.1
c) documents required for planning, implementation and control of all
4.2.1
operations of the organization;
d) documented product specifications for each category, type and
7.1/7.2
model of medical device manufactured in the facility;
e) there exists a procedure to test, review, improve and approve,
5.6
periodically, the quality management system for adequacy;
f) a system is established to check the compliance of the QMS with the
5.6
national/state regulations on manufacture of medical devices;
g) a process to prevent the use of out-dated QMS procedures and
4.2.3
documents by having an established system of updating the records.
4.3.2 Control of records
4.3.2.1 Organization shall maintain a robust records management system
a) all records pertaining to the quality management system shall be
4.2.4
maintained adequately and appropriately;
b) the records shall be maintained for the time period as prescribed by
national/state regulations or in absence of such a regulation, in 4.2.4
accordance to a defined and documented policy;
c) responsibility for record maintenance shall be given to identified
4.2.4
personnel;
d) records shall be preserved and maintained in environmentally safe
4.2.4
conditions;
e) management shall document and establish procedures to: 4.2.4
i. access, issue and obtain copy of records; 4.2.4
ii. address theft of records or conducting investigation for missing
4.2.4
records.
4.3.2.2 Record management policy shall support the quality policy of the organization
a) records which establish the conformity of the products to product
specifications and standards shall be maintained, including 8.2.4
batch/sample testing and product verification results;
b) records that do not establish the conformity of the products to
8.3
product specifications and standards shall be maintained;
c) records of audits, management reviews and observations of
compliance/non-compliance shall be kept under the supervision of 4.2.4
authorised personnel;
d) records of compliance to regulatory requirements shall be
maintained, including certificates required for establishing and 5.1 / 4.2.4
running a medical device manufacturing site;
e) records of improvisation or change in manufacturing technique,
6.2.2 / 7.5
infrastructure, and training of staff shall be maintained;
f) records of all preventive and corrective actions performed, shall be
8.5.2/ 8.5.3
maintained;
g) records of all verifications, validations and calibrations shall be
7.5 /7.6/8.2.4
maintained;
h) records of all user/customer feedback and complaints shall be
7.2.3
maintained;
i) records of components used for verification of product quality shall
8.2.4
be maintained;
j) records of all sale, installation and product commissioning shall be
7.2.2/ 8.2.4
maintained.
5. Management responsibility and commitment
a) the management shall provide evidence of its resolution to develop,
implement and improve the quality management system within the
5.1
organization by communicating to the organisation the importance of
meeting customer as well as statutory and regulatory requirements;
b) management reviews of the organization include assessment of the
performance of quality management system and this assessment is
documented. Top management shall review the organization's
5.6.1
quality management system, at planned intervals, to ensure its
continuing suitability, adequacy and effectiveness and maintain
records;
c) top Management shall establish a procedure to identify customer
requirements and to measure the capability of the organization to 5.2
meet those requirements;
d) there shall be a system to ensure that quality objectives and quality
management system is communicated to all the divisions of the 5.3/5.4
organization;
e) The management shall identify indicators to measure the
performance of QMS in all the divisions of the organization, which -5.4.1
includes collection of suitable data for performance measurement.
6. Resource management

6.1 Organization shall have appropriate and adequate human resources
a) the organization shall have documented information about the
minimum number of personnel required for each phase of 6.2
production;
b) the organization shall have documented information on the skills,
trainings and experience required by each category of personnel 6.2
required in the production process;
c) the organization shall have a documented procedure for selection,
induction, training and performance monitoring and appraisal of each 6.2
category of personnel;
d) the organisation shall comply with statutorily required qualifications
6.2
and competence levels for performing specific tasks;
e) the organisation shall ensure that personnel hired on temporary
basis/daily wages/short term contract, are competent to deliver the
6.2
inputs in the product manufacturing process and this is measured
before their involvement with the manufacturing process;
f) the personnel shall be made aware of duties, responsibilities and
6.2
expectations so as to promote product quality.
6.2. Organization shall have defined & documented policy and procedure for training the
personnel
a) there shall be a procedure to identify training requirements and a
documented training schedule/calendar for various categories of 6.2.2
personnel;
b) records of trainings shall be maintained for a specified time period; 6.2.2
c) there shall be a procedures to monitor and measure the
6.2.2
performance of personnel after the training programs;
d) training required for performing special tasks or tasks critical to
product quality shall be identified. Records of adequately trained
6.2.2
personnel and their competence level measured shall be
maintained.
6.3 Infrastructure
6.3.1 The organization has appropriate infrastructure to achieve quality product
a) appropriate building, fencing, shelter and environment controlling
devices shall be installed and made operational in the manufacturing
6.3/ 6.4
facility, as per the requirement of the products and manufacturing
processes;
b) appropriate energy storage and transmission equipment shall be in
operational state and national/state certifications of these 6.3/ 6.4
installations shall be valid as on date;
c) appropriate and adequate fire prevention and firefighting installations 6.3/ 6.4

shall be in functional state in the manufacturing facility;
d) the equipment existing in the manufacturing facility shall have been
assessed for their appropriateness for the manufacturing process 6.3/ 6.4
and is documented;
e) all such equipment shall comply with national/state/manufacturer’s
7.5.2
guidelines for installation, commissioning and functioning;
f) the appropriate equipment/ facilities shall be adequately installed in
the manufacturing facility for effective communication within the 6.3/ 6.4
different sections of the facility.
6.3.1.1 Specific area requirements shall be met adequately
The manufacturing area shall be identified into sections of appropriate
7.5.3 /6.3/8.3
size so as to prevent mix-up of conforming & non-conforming products.
6.3.2 The organization shall maintain an environment that supports product quality
a) there shall be documented information on the environmental
6.3/ 6.4
requirements of the facility;
b) there shall be a documented process planning to monitor, control
6.3/ 6.4
and maintain the required environment;
c) areas that need special environment conditions due to nature of
6.3/ 6.4
products at specific stages of production, shall be monitored;
d) there shall be devices installed to track the trend and regulate the
environment conditions (like temperature, pressure, light, humidity, 6.3/ 6.4
air velocity, particle size etc.) in areas that have special requirement;
e) adequate precautions shall be taken by means of appropriate
infrastructure to control and prevent pollution, dust, dirt and any 6.3/ 6.4
other form of contamination to the products/production area.
6.3.2.1 The organization shall maintain proper waste management
& disposal system
a) the waste management regulations as per national/state shall be
6.3/ 6.4
complied with;
b) the infrastructure for waste management & disposal systems shall
6.3/ 6.4
be checked by an appropriate authority and records maintained;
c) the waste management & disposal system shall not endanger the
6.3/ 6.4
quality or conformity of the product;
d) the personnel shall be adequately trained to follow a documented
6.2.2
waste management & disposal system;
e) any rejected or non-conforming product when disposed, the record
of the identity of such a product shall be maintained to avoid it’s re- 8.3
use.
6.3.2.2 The organization has a plan for the cleanliness of the facility
The reagents, chemicals or other items used for cleaning, fumigation or 6.1
disinfection and the procedure for their use shall be available.
6.3.3 Resources (manmade or natural) required to maintain appropriate environment
shall be available in right quality & quantity
a) the quality and quantity of water available in the facility shall be
appropriate for the production process and this appropriateness 6.3/ 6.4
shall be scientifically established and observations recorded;
b) the quality of air available in the facility shall be appropriate for the
production process and this appropriateness shall be scientifically 6.3/ 6.4
established and observations recorded;
c) the air velocity and direction shall be appropriate for the production
6.3/ 6.4
process;
d) records of trends of controlled environment shall be maintained for a
6.3/ 6.4
specified time period;
e) lighting requirements shall be specified and complied for various
6.3/ 6.4
stages of production.
6.3.3.1 Organisation shall plan for maintenance of all components of infrastructure
a) there shall be a documented periodic preventive maintenance plans
6.3
for building, equipment and other utility installations in the facility;
b) the records of preventive maintenance shall be maintained as per a
6.3
specified period;
c) organisation shall identify person(s) who is (are) responsible for
6.3
carrying out the maintenance;
d) maintenance procedure shall be documented, the lapses, delays
and/or exclusions in maintenance schedule shall be brought to the 6.3
notice of identified personnel;
e) the recommendations for conducting major repair that may arise
during such maintenance, shall be documented along with action 6.3
taken report.
7. Product realization
7.1 Planning of product realization
7.1.1 Organization shall plan for all the phases of product realization
a) there shall be a system to identify and provide all inputs required
7.1
for the various phases of product realization;
b) the objectives of quality management system shall be integrated
7.1
throughout product realization;
c) the organization shall maintain a production schedule; 7.1
d) the records of past production schedules shall be maintained as
7.1
per a defined and documented policy of the organization.
7.1.2 Organization shall established criteria for product acceptance
a) there shall be system to measure conformance of products 7.1/ 8.2.4
throughout the product realization process;
b) the product shall be verified and validated against pre-determined
7.1/8.2.4
standards;
c) there shall be documented acceptance and rejection criteria for all
7.1/ 8.2.4
products;
d) there shall be a system of monitoring and testing of all processes
7.1/ 8.2.3
that can influence product quality, acceptance and rejection.
7.1.3 Product realization shall meet intended and implied requirements
a) the product shall meet the requirements of the customer from the
point of completion of the products till the point of final use and shall 7.2.1
be documented.
b) the product shall meets national/state regulations; 7.2.1
c) when product requirements change (by law or by any other reason),
the product specifications shall be reassessed for its intended or 7.2.1
specified use and documented;
d) changes in product specifications shall be brought to the knowledge
7.2.3
of users/Customers.
7.1.4 The manufacturing plan incorporate product quality & safety
a) the various phases of manufacturing shall be identified; 7.5.1
b) defined controls shall exist at various stages to check and ensure
7.5.1
product conformity;
c) there shall be a system to monitor and test the accuracy in design
and specifications of the products during the various phases of 7.5.1
manufacturing;
d) the entire plan for product realization from design to dispatch shall
be documented including design input review, design output review, 7.3.1/ 7.5.1
design verification, design validation and design changes, if any;
e) product identification shall be done based on specified criteria; 7.5.3
f) personnel shall be made aware of the manufacturing plan, of their
7.5.1
roles and interactions during the various stages of the plan;
g) verification and validation of quality parameters for the product shall
7.3.4/ 7.3.5/ 8.2.4
be performed as per a documented process;
h) verification and validation of measuring instruments used for product
7.6
manufacturing shall be performed as per a documented process;
i) records of all calibrations, verification and validations shall be
7.6
maintained as per a defined policy.

7.2 Customer-related processes
7.2.1 Customer communication
The organization shall determine and implement effective arrangements for communication
within organization and with customers in relation to,
a) there shall be a communication system to exchange information on
5.5.3
product quality, within the various divisions of the organization;
b) communications to the users/customers regarding product quality,
precautions, product installation, maintenance and use is done 7.2.3
under an established procedure;
c) enquiries, contracts or order handling, including amendments, and 7.2.3
d) customer feedback, including customer complaints. 7.2.3
7.3 Traceability, labelling, Cleaning and/ or sterilization for products shall be ensured
7.3.1 Traceability
a) there shall be a defined policy to ensure traceability of all input
7.5.3
components used for product manufacturing;
b) there shall be a defined policy to ensure traceability of the final
7.5.3
products;
c) the traceability shall be ensured to the extent defined for various
7.5.3
products.
7.3.2 Labelling
a) the labelling of medical devices shall follow guidelines prescribed by
national/state/scientific recommendations including the mention of 7.5.3/ 7.5.5
shelf life/ expiry date of the product;
b) the extent and type of labelling shall include precautionary material
7.5.3
specific to the medical device;
c) there shall be a system to communicate information on packaging
7.2.3/7.5.5
and storing;
d) there shall be a procedure to ensure that the appropriate documents
are accompanied with products for the necessary instructions about 7.2.3/ 7.5.5
installation and usage of the product;
e) labelling tags for intended use shall be attached according to an
7.5.3
appropriate system to each product.
7.3.3. Cleaning and/ or Sterilization
a) there shall be defined and documented policy specific to the
products for performing the cleaning and/or sterilization of the 7.5.1
product at appropriate stages of the manufacturing;
b) there shall be defined & documented process based on which
7.5.1
cleaning and /or sterilization is performed;
c) there shall be a documented criteria based on which the cleaning
7.5.1
and/or sterilization completion is evaluated;
d) guidelines shall accompany the products that are to be subjected to
7.5.5
cleaning/sterilization before their final use for intended purposes;
e) there shall be procedures to prevent contamination of the products
7.5.1/7.5.5
by other potentially contaminated products;
f) the suitability of all input components that could influence the sterility
7.5.1
of products shall be assessed.
7.4 Operational Life Cycle Management
7.4.1 Organization shall ensure consistency in product characteristics
a) there shall be a system to confirm that the product specifications
8.2.4
match with those specified for the product;
b) any change in product specifications, uses and precautions related
7.3.7
to product use shall be incorporated in the relevant documents;
c) there shall be a documented policy that would prescribe procedure
for communication of changes in uses and precautions to the 5.5.3/7.2.3
existing users.
7.4.2 Installation procedures shall be determined by the organization
a) the installation protocols shall include briefing to the customer and
7.2.1/7.5.1
inspection of the site of installation;
b) the property of the customer that is handled by the organization
during the installation shall be conserved against undue damages 7.5.4
and this responsibility shall be defined in product installation policy;
c) the instructions for installation of the product shall be communicated 7.2.1/ 7.2.3/
with adequate documentation; 7.5.1/7.5.5
d) the shelf life of the product, including its warranty/guarantee period
shall be mentioned in the documents supplied to the customer with 7.5.5
the product.
7.4.3 Organization shall maintain after sale documents
a) if defects or non-conformity is detected in the product after receipt of
the product at the installation site, there shall be an established and 8.3
documented procedures to initiate return/repair of the product;
b) products returned to the manufacturer after delivery to the customer
8.3
shall undergo a process of identification;
c) rejected/ returned products to the manufacturer shall be kept
8.3
separate from the conforming products;
d) there shall be a system to initiate investigation of the cause of non-
8.5.2
conformity and procedures to prevent re-occurrence.
7.4.4. Non-conformity after dispatch and maintenance procedures shall be determined by
the organization
a) when the non-conformity is detected after installation or after the
8.3
product has been operationalized, there shall be a system to detect
and document the effects and impacts of such a non-conformity if
any;
b) there shall be a system to preserve the quality of the product during
7.5.5
the transit;
c) any non-conformity arising during the transit shall be brought to the
notice of the manufacturer and the customer based on a specific 7.5.5/ 8.3
procedure;
7.4.5 The organization shall arrange for post-production requirements
a) there shall be a system to evaluate the ability of the product to meet
8.2.4
intended use;
b) verification of the product shall be performed according to an
8.2.4
established procedure and results shall be documented;
c) validation of the product shall be performed according to an
7.3.6
d) there shall be a system to identify non conformity in final product and
8.2.4/ 8.3
initiate corrective action;
e) there shall be a system to record any deviations in the product as
8.3
compared the documented characteristics defined for that product;
f) there shall be a system to handle unintended acceptance and/or use
8.3
of non-conforming products.
7.5 Purchase
7.5.1 Organization shall have a procurement system that supports product quality
a) there shall be a system to check the quality and specifications of
input components that are used in the manufacturing of the final 7.4.3/ 8.2.4
product;
b) the input components shall be selected based on pre-defined and
7.4.3/ 8.2.4
documented criteria and undergo verification before usage;
c) there shall be a system to identify and separate the non-conforming
input components and to prevent their unintended use in the 8.3
manufacturing process;
d) there shall be a system to ensure the use of proper instruments and
7.5.1
equipment for the manufacturing process of all products.
8. Responsibility of Management – Measurement, Analysis and Improvement
8.1 Organization shall be led by a management which promotes quality in products and
consistency in processes
a) there shall be evidence of management effort to promote quality &
5.1/5.5
safety in all the products;
b) there shall be defined and documented roles and responsibilities for
5.5
every member of organization;
c) there shall be documented procedures to monitor and measure the 5.6
performance of quality management system;
d) there shall be records of compliance of all regulatory and/or
5.1
national/state regulations;
e) there shall be a defined procedure to update the requirement of
quality management system, regulatory requirements and product 5.4.2/5.6.1
safety guidelines.
8.2 Organization shall have appropriate and adequate number of audits
a) there shall be documented procedures to conduct audits; 8.2.2
b) audits shall be conducted at specified time intervals by qualified and
8.2.2
competent auditors, independent of the area of their activity;
c) there shall be evidence for the action taken on the recommendations
8.2.2
of the audit findings along with reasons for not taking action (if any);
d) there shall be records of internal and/or external audits of the
processes of the facility and the records are preserved for a 8.2.2
specified time period.
8.3 Organization shall ensure product safety, reliability and credibility
a) there shall be a documented management policy for preserving and
7.5.5
promoting products quality;
b) there shall be defined and documented procedures to promote
product reliability and reasons for failing product reliability is 8.4
analyzed and recorded;
c) there shall be procedures to educate the existing and new
customers/users of the product, of any changes in the product 7.2.3
quality and safety before or after its sale and/or use;
d) there shall be a procedure to collect, analyze and incorporate
8.2.1
customer/user feedback in enhancing the product quality;
e) adequate information shall be provided to the customer/user about
scope, limitations and jurisdiction of any legal dispute that may arise 7.2.1
about the product.
f) there shall be a policy to take appropriate permission from
national/state/regulatory authority, before including a medical device
product for any clinical trial that needs to be conducted to establish 5.1/7.3.6
the efficacy of effect of the medical device. Not applicable for clinical
evaluation & investigations;
g) the organization shall have established procedures for incorporating
8.4/ 8.5.1
continuous quality improvement in the product.
8.4 Assessment and improvement in the quality management system
a) there shall be a system for the assessment and improvement of
5.6/ 8.5
b) there shall be a system to collect view, feedbacks and reports on 5.6/ 8.4
c) there shall be a system for detection of failures/ non conformities in
8.2.3 / 8.2.4
d) there shall be a system to initiate action to rectify the failures/ non
conformities identified in the quality management system and 8.5.2
prevent it’s reoccurrence.

Bibliography
1. ISO 8402, Quality management and quality assurance Vocabulary.
2. ISO 9001 :2008, Quality management systems – Requirements
3. ISO 10001, Quality management — Customer satisfaction — Guidelines for codes of

conduct for organizations
4. ISO 10002, Quality management — Customer satisfaction — Guidelines for complaints

handling in organizations
5. ISO 10012, Measurement management systems — Requirements for measurement

processes and measuring equipment
6. ISO 10015, Quality management — Guidelines for training
7. ISO 14001, Environmental management systems — Requirements with guidance for use
8. ISO 19011, Guidelines for quality and/or environmental management systems auditing
9. ISO 11134, Sterilization of health care products - Requirements for validation and routine
control- Industrial moist heat sterilization
10. ISO 11135, Medical devices - Validation and routine control of ethylene oxide sterilization
(Corrigendum 1 published 1994)
11. ISO 11137, Sterilization of health care products - Requirements for validation and routine
control- Radiation sterilization (Corrigendum 1 published 1995; Amendment 1 published
2001)
12. ISO 13641, Elimination or reduction of risk of infection related to in vitro diagnostic
medical devices
13. ISO 13683, Sterilization of health care products - Requirement for validation and routine
control of moist heat sterilization in health care facilities
14. ISO 14155-1, Clinical investigation of medical devices for human subjects - Part 1:
General requirements
15. ISO 14155-2, Clinical investigation of medical devices for human subjects - Part 2: Clinical
investigation plans

16. ISO 14160, Sterilization of medical devices - Validation and routine control of sterilization
of Single-use medical devices incorporating materials of animal origin by liquid chemical
sterilants
17. ISO 14937, Sterilization of health care products - General requirements for
characterization of a sterilizing agent and the development, validation and routine control
of a sterilizing agent
18. ISO/TR 14969:-1), Medical devices - Quality management systems - Guidance on the
application of ISO 13485:2003
19. ISO 14971, Medical devices - Application of risk management to medical devices
20. ISO 15223-1, Medical devices -- Symbols to be used with medical device labels, labelling
and information to be supplied -- Part 1: General requirements
21. ISO 19011, Guidelines for quality and/or environmental management systems auditing

Amendment Sheet
RECORD OF CURRENT STATUS OF THE
Technical Criteria for Certification of Medical Devices
The current status of each page and the history of change of the Technical Criteria for
Certification of Medical Devices are set out below.
Sl. No. Date Of Amendment Page No. Amendment details
 Highlighting is used within the text of the Requirements to identify current amendments
with any deleted text shown with a strikethrough.
 Previous amendments or revisions are incorporated into the text. Where text on an
individual page is amended the page will be reissued.
 Each reissued page is identified in the header as a ‘page amendment’ making reference
to the “revision number” and the “revision issue date”.

LABELLING CHECKLIST
REQUIREMENTS FOR MEDICAL DEVICES
A. Information mandatory to be marked on the ‘Unit pack for sale’ of Device.
1. Name / Trade Name of the device.
2. The Name & Address of manufacturer
3. Lot / Batch No.
4. Date of Expiry
5. Indication for single use (if applicable)
6. The word “STERILE” (For Sterile Devices)
7. Caution in event of damage to sterile pack
8. Max. Retail Price
B. If space constraint “unit pack for sale”, the following information is also mandatory
on secondary pack of Device, user/ consumer can be cautioned by use of caution
symbol on the unit pack.
1. Device description
2. Mfg. Lic. No. (if applicable)
3. Date of Mfg.
4. Storage / handling instruction
5. Operating instruction / Instruction for use, where appropriate
6. Method of sterilization (For Sterile Devices)
7. Warning / Precautions & Symbols (if applicable)
8. Customer care –Contact Detail.
Note 1. As far as it is practicable and appropriate, the information needed to identify and use
the device safely should be provided on the device itself, and/or on the packaging for each unit,
and/or on the packaging of multiples devices.

Note 2. As far as practicable and appropriate, the information needed to use the Device
safely to be given on the Device itself and/or on the packaging for each unit or, where
appropriate, on the sales packaging. If individual packaging of each unit is not
practicable, the information to be given in the leaflet/ Information to Use supplied with
one or more Devices.
Note 3. Each Device to be accompanied by the information needed to use it safely and
properly, taking account of the training and knowledge of the potential users, and to
identify the manufacturer.
Note 4. Where appropriate, the information should take the form of symbols. Any symbol
or identification colour used must conform to the harmonized Standards. In areas for
which no Standards exist, the symbols and colours must be described in the
documentation supplied with the Device”. Graphical symbol as per ISO 15223 can be used
as appropriate for all of above. Any additional labeling requirement specified in related product
standard to be included appropriately.
Note 5. The unit pack can be containing more than one number or type of medical devices.

ICMED 13485

Medical Devices

ICMED (Scheme)
Technical Criteria for Certification of

Medical Devices – ICMED 13485

Medical Devices
COMPOSITION
Chairman
Mr. PK Sharma Association of Indian Medical Device Industry (AIMED)
Mr. R. Sachdeva Association of Certification bodies Of India
Mr. Sempal
Technology, Delhi
Ms. Sumati Randeo
Ms. Kirti Arora
Ms. Pallavi Saha Engineering Export Promotion Council (EEPC)
Mr. Mayank Krishna
Dr. K .K. Agrawal Indian Medical Association (IMA)
Dr. R.N. Tandon
Dr. Jitendra Kumar Sharma National Health Systems Resource Centre (NHSRC)
Mr. Mohammad Ameel
Mr. M. Jena
Dr. B.K. Rao The Associated Chambers of Commerce and Industry of
India
Mr. Karanveer Singh
Member – Secretary

TABLE OF CONTENTS
Technical Committee for QCI – AIMED

1. Scope ....................................................................................................... 39
1.3 Text in Italic is in addition to the requirement ISO 13485: 2003.......... 39
1.4 Application .......................................................................................... 39
2. Normative references ............................................................................. 40
3. Terms and definitions ............................................................................ 40
4. Quality management systems ............................................................... 40
Corresponding Clause of ISO 13485: 2003 .............................................. 40
4.1 General requirements .................................................................... 40
4.2 Quality Management System processes shall be appropriate
to the needs of the organization .................................................... 40
4.2.1 The organization shall determine the process components ........... 41
4.3 Documentation requirements ........................................................ 41
4.3.1 The organization shall have following minimum documents .......... 41
4.3.2 Control of records .......................................................................... 41
5. Management responsibility and commitment ...................................... 42
6. Resource management .......................................................................... 43
human resources ........................................................................... 43
6.2. Organization shall have defined & documented policy and
procedure for training the personnel .............................................. 44
6.2.1 Organization ensures good health of staff against
occupational hazards..................................................................... 44
6.3.1 The organization has appropriate infrastructure to
achieve quality product .................................................................. 44
6.3.2 The organization shall maintain an environment that
supports product quality ................................................................ 45
6.3.3 Resources (manmade or natural) required to maintain appropriate
environment shall be available in proper quality & quantity ........... 46

7. Product realization ................................................................................. 47
7.1 Planning of product realization ...................................................... 47
7.1.1 Organization shall plan for all the phases of product realization .... 47
7.1.2 Organization has established criteria for product acceptance ....... 47
7.1.3 Product realization meets intended and implied requirements ...... 48
7.1.4 The manufacturing plan incorporates product quality & safety ...... 48
7.2 Customer-related processes ......................................................... 49
7.2.1 Customer communication .............................................................. 49
7.3 Traceability, labelling, cleaning and/or sterilization for
products shall be ensured ............................................................. 49
7.3.1 Traceability .................................................................................... 49
7.3.2 Labelling ........................................................................................ 49
7.3.3 Cleaning and/or sterilization .......................................................... 49
7.4 Operational Life Cycle Management ............................................. 50
7.4.1 Organization shall ensure consistency in product characteristics .. 50
7.4.2 Installation procedures shall be determined by the organization ... 50
7.4.3 Organization shall maintain after sale documents ......................... 51
7.4.4 Non-conformity after dispatch and maintenance procedures shall be
determined by the organization ..................................................... 51
7.4.5 The organization shall arrange for post-production requirements . 52
7.5 Purchase ....................................................................................... 52
7.5.1 Organization shall have a procurement system that supports product
quality ............................................................................................ 52
8. Responsibility of Management – Measurement,
Analysis and Improvement .................................................................... 52
8.1 Organization shall be led by a management which promotes quality in
products and consistency in processes ......................................... 52
number of audits ............................................................................ 53
8.3 Organization ensures product safety, reliability and credibility ...... 53
8.4 Assessment and improvement in the Quality
Management System..................................................................... 54
Bibliography ................................................................................................... 55
Amendment Sheet ......................................................................................... 57

1. Scope
1.1 This document specifies the requirements for a quality management systems for
medical device industry which
a) needs to demonstrate its ability to consistently provide medical devices that meet
customer and applicable statutory and regulatory requirements, and
b) aims to enhance customer satisfaction through the effective application of the

system, including processes for continual improvement of the system and the
assurance of conformity to customer and applicable statutory and regulatory
requirements.
1.2 The requirements prescribed in this document shall be read with the requirements
prescribed in ISO 13485: 2003.
1.3 Text in Italic is in addition to the requirement ISO 13485: 2003
1.4 Application
All requirements of this ICMED Standard are generic to organizations providing medical
devices, regardless of the type or size of the organization.
If regulatory requirements permit exclusions of design and development controls (see

7.1.4.d), this can be used as a justification for their exclusion from the quality
management system. These regulations can provide alternative arrangements that are
to be addressed in the quality management system. It is the responsibility of the
organization to ensure that claims of conformity with this ICMED Standard reflect
exclusion of design and development controls
If any requirement(s) of this iCMED Standard is(are) not applicable due to the nature of
the medical device(s) for which the quality management system is applied, the
organization does not need to include such a requirement(s) in its quality management
system and appropriate justification shall be recorded.
The processes required by this ICMED Standard, which are applicable to the medical
device(s), but which are not performed by the organization, are the responsibility of the
organization and are accounted for in the organization's quality management system

2. Normative references
The following referenced documents are indispensable for the application of this document.
a. ISO 9000 Quality management systems - Fundamentals and vocabulary
b. ISO 13485: 2003 Medical devices – Quality management systems – requirements for
regulatory purposes
3. Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 9000 and ISO
13485 shall apply.
Wherever requirements are specified as applying to "medical devices", the requirements

apply equally to related services as supplied by the manufacturing facility.
Corresponding
4. Quality management systems Clause of ISO
13485: 2003
4.1 General requirements
a) the medical devices manufacturer shall have an established and
documented system for implementation and maintenance of a quality 4.1
management system;
b) the system includes identification of indicators to measure the
5.4.1
effectiveness of the quality management system;
c) the periodicity of measuring of these indicators is defined and
5.6.1
documented;
d) the processes required for the implementation of the quality
4.1
management system are identified and documented.
4.2 Quality Management System processes shall be appropriate to the needs of the
organization
a) the organization shall have an established system to identify all the
4.1
processes, their sequences, results, and interactions;
b) there shall be defined criteria to measure the compliance and
4.1
effectiveness of all the processes;
c) there shall be a system to measure the adequacy of inputs required
4.1
for the implementation of all the processes;
d) there shall be a system to evaluate and improve the processes
8.4/8.5.1
based on measurement of defined indicators.

4.2.1 The organization shall determine the process components
a) the organization shall determine the time line for completion of each
4.1
process;
b) there shall be a system to track any delay of time period in the
4.1
completion of processes;
c) there shall be a system within the organization to measure the
correctness of those processes of sub-parts of a process that the 4.1
organization outsources from agencies external to the organization;
d) the various components of all processes with the organization shall
4.1
be defined and documented;
e) the organization shall identify individuals responsible for all the
5.5.1
processes including management representative (M.R.);
f) all the processes required for manufacturing, identification, storing,
pre-market authorization, sale, installation, maintenance, repair and 7.1
disposal shall be documented for every product.
4.3.1 The organization shall have following minimum documents
a) a quality manual which has defined scope, exclusions (if any) and
4.2.2
procedures covering all operations of the organization;
b) defined quality policy and quality objectives; 4.2.1/5.3/5.4.1
c) documents required for planning, implementation and control of all
4.2.1
operations of the organization;
d) documented product specifications for each category, type and
4.2.1/7.1/7.2
model of medical device manufactured in the facility;
e) there exists a procedure to test, review, improve and approve,
5.6.1
periodically, the quality management system for adequacy;
f) a system is established to check the compliance of the quality
management system with the national/state regulations on 5.6
manufacture of medical devices;
g) a process to prevent the use of out-dated QMS procedures and
4.2.3
documents by having an established system of updating the records.
4.3.2 Control of records
4.3.2.1 Organization shall maintain a robust records management system
a) all records pertaining to the quality management system shall be
4.2.4
maintained adequately and appropriately;
b) the records shall be maintained for the time period as prescribed by
national/state regulations or in absence of such a regulation, in 4.2.4
accordance to a defined and documented policy;

c) responsibility for record maintenance shall be given to identified
4.2.4
personnel;
d) records shall be preserved and maintained in environmentally safe
4.2.4
conditions;
e) management shall document and establish a procedures to, 4.2.4
(i) access, issue and obtain copy of records; 4.2.4
(ii) address theft of records or conducting investigation for missing
4.2.4
records.
4.3.2.2 Record management policy shall support the quality policy of the organization
a) records which establish the conformity of the products to product
specifications and standards shall be maintained including 8.2.4
batch/sample testing and product verification results;
b) records that do not establish the conformity of the products to
8.3
product specifications and standards shall be maintained;
c) records of audits, management reviews and observations of
compliance/non-compliance shall be kept under the supervision of 4.2.4
responsible and identified authorised personnel;
d) records of compliance to regulatory requirements shall be
maintained, including certificates required for establishing and 4.2.4
running a medical device manufacturing site;
e) records of improvisation or change in manufacturing technique,
6.2/ 7.5
infrastructure, and training of staff shall be maintained;
f) records of safety management systems and adverse incidents shall
7.2.3/8.5.1
be maintained;
g) records of all preventive and corrective actions performed shall be
8.5.2/ 8.5.3
maintained;
h) records of all verifications, validations and calibrations shall be
4.2.4/ 7.5 /7.6/8.2.4
maintained;
i) records of all user/customer feedback and complaints shall be
7.2.3
maintained;
j) records of components used for verification of product quality shall
8.2.4
be maintained;
k) records of all sale, installation and product commissioning shall be
7.5.1
maintained.
5. Management responsibility and commitment
a) the management shall provide evidence of its resolution to develop,
implement and improve the quality management system within the
5.1
organization by communicating to the organisation the importance of
meeting customer as well as statutory and regulatory requirements;

b) management reviews of the organization include assessment of the
performance of quality Management System and this assessment is
documented. Top management shall review the organization's
5.6.1
quality management system, at planned intervals, to ensure its
continuing suitability, adequacy and effectiveness and maintain
records;
c) top Management shall establish a procedure to identify customer
requirements and to measure the capability of the organization to 5.2
meet those requirements;
d) there shall be a system to ensure that quality objectives and quality
management system is communicated to all the divisions of the 5.3/ 5.4
organization;
e) the management shall identify indicators to measure the
performance of quality management system in all the divisions of the
5.6.1
organization, which includes collection of suitable data for
performance measurement.
6. Resource management
6.1 Organization shall have appropriate and adequate human resources
a) the organization shall have documented information about the
minimum number of personnel required for each phase of 6.2
production;
b) the organization shall have documented information on the skills,
trainings and experience required by each category of personnel 6.2
required in the production process;
c) the organization shall have a documented procedure for selection,
induction, training and performance monitoring and appraisal of each 6.2
category of personnel;
d) the organisation shall comply with statutorily required qualifications
6.2
and competence levels for performing specific tasks;
e) the organisation shall ensure that personnel hired on temporary
basis/daily wages/short term contract are competent for product
6.2
manufacturing process and this is measured before their
involvement with the manufacturing process;
f) the personnel shall be made aware of duties, responsibilities and
6.2
expectations so as to promote product quality;
g) there shall be defined and documented procedures to take
appropriate action for negligence of duty, especially when such 6.2
negligence adversely affects product quality;
h) there shall be defined procedures to address personnel grievances. 6.2

6.2. Organization shall have defined & documented policy and procedure for training the
personnel
a) there shall be a procedures to identify training requirements and a
documented training schedule/calendar for various categories of 6.2
personnel;
b) records of trainings shall be maintained for a specified time period; 6.2
c) there shall be procedures to monitor and measure the performance
6.2
of personnel after the training programs;
d) training required for performing special tasks or tasks critical to
product quality shall be identified. Records of adequately trained 6.2
personnel and their competence level measured shall be maintained.
6.2.1 Organization ensures good health of staff against occupational hazards
a) there shall be defined and documented procedures to protect and
6.2
promote health of the personnel;
b) the procedures shall include a documented schedule and plan for
6.2
screening of adverse health effects of work on the personnel;
c) there shall be procedures to provide compensation to the personnel
in case of any adverse effects on health or life of the personnel due 6.2
to nature of work.
6.3.1 The organization has appropriate infrastructure to achieve quality product
a) appropriate building, fencing, shelter and environment controlling
devices shall be installed and operational in the manufacturing
6.3/ 6.4
facility, as per the requirement of the products and manufacturing
processes;
b) appropriate energy storage and transmission equipment shall be in
operational state and national/state certifications of these 6.3/ 6.4
installations are valid as on date;
c) appropriate and adequate fire prevention and firefighting installations
6.3/ 6.4
shall be in functional state in the manufacturing facility;
d) the equipment existing in the manufacturing facility shall be
assessed for their appropriateness for the manufacturing process 6.3/ 6.4
and is documented;
e) all such equipment shall comply with national/state/manufacturer’s
7.5.2
guidelines for installation, commissioning and functioning;
f) the appropriate equipment/ facilities shall be adequately installed in
the manufacturing facility for effective communication within the 6.3/ 6.4
different sections of the facility.

6.3.1.1 Specific area requirements shall be met adequately
a) the manufacturing area shall be identified into sections of
appropriate size so as to prevent mix-up of conforming & non- 6.3/ 7.5.3/8.3
conforming products;
b) the area size and area environment of each section of the
manufacturing site dedicated to a specific process/processes shall 6.3/ 6.4
be conducive for integration of quality components in the product;
c) material receipt areas, Storage areas, cleaning and processing
areas shall be segregated to avoid mix up of products that may exist 6.3/ 6.4
during different stages of production;
d) areas where products of biological origin are being used shall be
6.3/ 6.4/ 7.5.5
segregated physically & environmentally.
6.3.2 The organization shall maintain an environment that supports product quality
a) there shall be documented information on the environmental
6.3/ 6.4
requirements of the facility;
b) there shall be a documented process planning to monitor, control
6.3/ 6.4
and maintain the required environment;
c) areas that need special environment conditions due to nature of
6.3/ 6.4
products at specific stages of production shall be monitored;
d) there shall be devices installed to track the trend and regulate the
environment conditions (like temperature, pressure, light, humidity, 6.3/ 6.4
air velocity, particle size etc.) in areas that have special requirement;
e) adequate precautions shall be taken by means of appropriate
infrastructure to control and prevent pollution, dust, dirt and any 6.3/ 6.4
other form of contamination to the products/production area.
6.3.2.1 The organization shall maintain proper waste management & disposal system
a) the waste management regulations as per national/state regulations
5.1/ 6.3/ 6.4
shall be complied with;
b) the infrastructure for waste management & disposal systems shall be
6.3/ 6.4
checked by an appropriate authority and records maintained;
c) the waste management & disposal system shall not endanger the
6.3/ 6.4
quality or conformity of the product;
d) the personnel shall be adequately trained to follow a documented
6.2
waste management & disposal system;
e) any rejected or non-conforming product when disposed, the record
of the identity of such a product shall be maintained to avoid it’s re- 8.3
use.

6.3.2.2 The organization has a plan for the cleanliness of the facility
a) there shall be a documented procedures for cleaning, fumigation,
disinfection of various parts of the manufacturing facility as per 6.3/ 6.4
requirements of the production process;
b) the reagents, chemicals or other items used for cleaning, fumigation
6.1
or disinfection and the procedure for their use shall be available;
c) the schedule for cleaning, fumigation, disinfection of various sections
of the manufacturing facility shall be documented and compliance 6.3/ 6.4
recorded;
d) there shall be a documented procedure(s) to monitor the indicators
suggestive of appropriately clean environment (cultures) at specified 6.3/ 6.4
places in the manufacturing site;
e) there shall be a documented procedure(s) to protect specific
6.3/ 6.4
manufacturing equipment from contamination;
f) there shall be a procedures for restricted entry into clean areas; 6.3/ 6.4
g) there shall be a documented procedures for disinfection of
personnel, items and clothing before their entry into clean/aseptic 6.3/ 6.4
areas;
h) there shall be a documented procedures for disposal of
6.3/ 6.4
contaminated items;
i) there shall be a documented procedures to periodically screen the
health of the personnel who are required to work in clean/aseptic 6.3/ 6.4
areas;
j) there shall be a documented code for hand washing, clothing,
masking, gowning for personnel who are required to work in 6.3/ 6.4
clean/aseptic areas.
6.3.3 Resources (manmade or natural) required to maintain appropriate environment
shall be available in proper quality & quantity
a) the quality and quantity of water available in the facility shall be
appropriate for the production process and this appropriateness is 6.3/ 6.4
scientifically established and observations recorded;
b) the quality of air available in the facility shall be appropriate for the
production process and this appropriateness is scientifically 6.3/ 6.4
established and observations recorded;
c) the air velocity and direction shall be appropriate for the production
6.3/ 6.4
process;
d) records of trends of controlled environment shall be maintained for a
6.3/ 6.4
specified time period;
e) lighting requirements shall be specified and complied for various
6.3/ 6.4
stages of production.

6.3.3.1 Organization shall plan for maintenance of all components of infrastructure
a) there shall be documented periodic preventive maintenance plans
6.3
for building, equipment and energy installations in the facility;
b) the records of preventive maintenance shall be maintained as per
6.3
specified period;
c) organisation shall identify person(s) who is (are) responsible for
6.3
carrying out the maintenance;
d) maintained procedure shall be documented, the lapses, delays
and/or exclusions in maintenance schedule shall be documented 6.3
and brought to the notice of identified personnel;
e) the recommendations for conducting major repair that may arise
during such maintenance shall be documented along with action 6.3/
taken report.
7. Product realization
7.1 Planning of product realization
7.1.1 Organization shall plan for all the phases of product realization
a) there shall be a system to identify and provide all inputs required for
7.1
the various phases of product realization;
b) the organisation shall provide resources specific to the product; 6.1
c) the organisation shall document verification, validation, monitoring,
measurement, inspection and test activities specific to the product 7.1/8.2.4
and the criteria for product acceptance;
d) the objectives of Quality Management System shall be integrated
7.1
throughout product realization;
e) there shall be a system to identify risks to product quality during the
phases of product realization and documented procedures for risk 7.1
minimization;
f) the organization shall maintain a production schedule; 7.1
g) the records of past production schedules shall be maintained as per
7.1
a defined and documented policy of the organization;
h) the organization shall keep records needed to provide evidence that
7.1
the realization processes and resulting product meet requirements.
7.1.2 Organization has established criteria for product acceptance
a) there shall be system to measure conformance of products
7.1/ 8.2.4
throughout the product realization process;
b) the product shall be verified and validated against pre-determined
7.1/8.2.4
standards;
c) there shall be documented acceptance and rejection criteria for all
7.1/ 8.2.4
products;

d) there shall be system of monitoring and testing of all processes that
7.1/ 8.2.4
can influence product quality, acceptance and rejection.
7.1.3 Product realization meets intended and implied requirements
a) customer requirements related to the products shall be defined,
7.2.1/ 7.2.2
reviewed and documented;
b) the products shall meet the requirements of the customer from the
point of completion of the products till the point of final use and is 7.2.1
documented;
c) the product shall meet national/state regulations; 7.2.1
d) when product requirements change (by law or by any other reason),
the product specifications shall be reassessed for its intended or 7.2.1
specified use and documented;
e) changes in product specifications shall be brought to the knowledge
7.2.3
of users/Customers.
7.1.4 The manufacturing plan incorporates product quality & safety
a) the various phases of manufacturing shall be identified; 7.5.1
b) defined controls shall exist at various stages to check and ensure
7.5.1
product conformity;
c) there shall be a system to monitor and test the accuracy in design
and specifications of the products during the various phases of 7.5.1
manufacturing;
d) the entire plan for product realization from design to dispatch shall
be documented including Design Input Review, Design Output
7.3.1/ 7.5.1
Review, Design Verification, Design Validation and Design Changes,
If any;
e) product identification shall be done based on specified criteria; 7.5.3
f) personnel shall be made aware of the manufacturing plan, of their
7.5.1
roles and interactions during the various stages of the plan;
g) verification and validation of quality parameters for the product shall
7.3.4/ 7.3.5 /8.2.4
be performed as per a documented process;
h) verification and validation of measuring instruments used for product
7.6
i) verification and validation of computer programs used for product
7.6
j) records of all calibrations, verification and validations shall be
7.6
maintained as per a defined policy;
k) validation of processes of production shall be performed as per a
7.5.2
documented process.

7.2 Customer-related processes
7.2.1 Customer communication
The organization shall determine and implement effective arrangements for communication
within organization and with customers in relation to;
a) there shall be a communication system to exchange information on
5.5.3
product quality, within the various divisions of the organization;
b) information crucial to product quality shall be communicated within a
5.5.3
specified time period as per a defined and documented policy;
c) communications to the users/customers regarding product quality,
precautions, product installation, maintenance and use shall be done 7.2.3
under an established procedure;
d) enquiries, contracts or order handling, including amendments, and; 7.2.3
e) customer feedback, including customer complaints. 7.2.3
7.3 Traceability, labelling, cleaning and/or sterilization for products shall be ensured
7.3.1 Traceability
a) there shall be a defined policy to ensure traceability of all input
7.5.3
components used for product manufacturing;
b) there shall be a defined policy to ensure traceability of the final
7.5.3.2
products;
c) the traceability shall be ensured to the extent defined for various
7.5.3.2
products;
d) there exists a system to initiate appropriate action whenever
7.5.3
traceability is compromised.
7.3.2 Labelling
a) the labelling of medical devices shall follow guidelines prescribed by
national/state/scientific recommendations including the mention of 7.5.3/7.5.5
shelf life/ expiry date of the product;
b) the extent and type of labelling shall include precautionary material
7.5.3
specific to the medical device;
c) there shall be a system to communicate information on packaging
7.5.5/7.2.3
and storing;
d) there shall be a procedure to ensure that the appropriate documents
are accompanied with products for the necessary instructions about 7.5..2.3/7.5.5
installation and usage of the product;
e) labelling tags for intended use shall be attached according to an
7.5.3
appropriate system to each product.
7.3.3 Cleaning and/or sterilization
a) there shall be defined and documented policy specific to the
products for performing the cleaning and/or sterilization of the 7.5.1.2
product at appropriate stages of the manufacturing;
b) there shall be defined & documented process based on which
cleaning and /or sterilization is performed and validated prior to 7.5.1.2
market release;
c) there shall be a documented criteria based on which the cleaning
and/or sterilization completion is evaluated, maintained and records 7.5.1.2
maintained;
d) guidelines shall accompany the products that are to be subjected to
7.5.1.2/7.5.5
cleaning/sterilization before their final use for intended purposes;
e) there shall be procedures to prevent contamination of the products
7.5.1.2/7.5.5
by other potentially contaminated products;
f) the suitability of all input components that could influence the sterility
7.4.3/7.5.1
of products shall be assessed.
7.4 Operational Life Cycle Management
7.4.1 Organization shall ensure consistency in product characteristics
a) there shall be a system to confirm that the product specifications
8.2.4
match with those specified for the product;
b) any change in product specifications, uses and precautions related
7.3.7
to product use shall be incorporated in the relevant documents;
c) there shall be a documented policy that would prescribe procedure
for communication of changes in uses and precautions to the 7.2.3/ 7.3.7/5.5.3
existing users.
7.4.2 Installation procedures shall be determined by the organization
a) the installation protocols shall include briefing to the customer and
7.5.1.2.2
inspection of the site of installation;
b) there shall be a system to maintain the details of transportation of
7.5.5
medical devices and record of this is maintained for a defined period;
c) for specific products as per defined policy, the unique identification of
product shall be maintained throughout the sales, delivery, 7.5.3.2
installation process and after installation;
d) the requirements for product installation that are expected from the
customer’s side shall be specified beforehand giving customer a time 7.5.1.2.2
period as per the defined policy;
e) the property of the customer that is handled by the organization
during the installation shall be conserved against undue damages 7.5.4
and this responsibility shall be defined in product installation policy;
f) the instructions for installation of the product shall be communicated
7.5.1.2.2
with adequate documentation;
g) the shelf life of the product, including its warranty/guarantee period
shall be mentioned in the documents supplied to the customer with 7.5.1.2.2
the product;
h) there shall be a defined policy for the financial responsibility of any
damage to the product from the point of dispatch to the point of 7.5.1.2.2
receipt at the installation site;
i) there shall be a system to ensure that the arrangements
(infrastructure/energy/manpower requirements etc.) for installation 7.5.1.2.2
are completed before the installation phase begins;
j) there shall be a documented system to ensure the compliance of all
regulatory requirements necessary for the medical device installation 7.5.1.2.2
and scheduled operation before the installation begins;
k) there shall be a system to maintain documentation of completion of
7.5.1.2.2
installation and successful operation of the medical device.
7.4.3 Organization shall maintain after sale documents
a) if defects or non-conformity is detected in the product after receipt of
the product at the installation site, there shall be an established and 8.3
documented procedures to initiate return/repair of the product;
b) products returned to the manufacturer after delivery to the customer
8.3
shall undergo a process of identification;
c) rejected/ returned products to the manufacturer shall be kept
8.3
separate from the conforming products;
d) there shall be a system to initiate investigation of the cause of non-
8.5.2
conformity and procedures to prevent re-occurrence.
7.4.4 Non-conformity after dispatch and maintenance procedures shall be determined by
the organization
a) the maintenance manual shall be included as per a defined policy
7.5.1.2.3
for every specified category of products;
b) records of servicing activities performed by the manufacturer shall be
7.5.1.2.3
documented;
c) the unique identification of product shall be maintained after
7.5.1.2.3
installation – for specific products as per a defined policy;
d) if the investigation for the cause of non-conformity is not performed,
the reason for not performing such investigation shall be 8.5
documented;
e) when the non-conformity is detected after installation or after the
product has been operationalized, there shall be a system to detect
8.3
and document the effects and impacts of such a non-conformity, if
any;
f) there shall be a system to preserve the quality of the product during
7.5.5
internal processing, transit and delivery to the intended destination;

g) any non-conformity arising during the transit shall be brought to the
notice of the manufacturer and the customer based on a specific 7.5.5/8.3
procedure.
7.4.5 The organization shall arrange for post-production requirements
a) there shall be a system to evaluate the ability of the product to meet
8.2.4
intended use;
b) verification of the product shall be performed according to an
8.2.4
c) validation of the product shall be performed according to an
7.3.6
d) there shall be a system to identify non conformity in final product and
8.2.4/ 8.3
initiate corrective action;
e) there shall be a system to record any deviations in the product as
8.3
compared the documented characteristics defined for that product;
f) there shall be a system to handle unintended acceptance and/or use
8.3
of non-conforming products.
7.5 Purchase
7.5.1 Organization shall have a procurement system that supports product quality
a) there shall be a system to select and evaluate suppliers based on
their ability to supply product as per product/ organisation 7.4.1
requirements;
b) purchase requirements including purchase product specification
7.4.2
shall be adequately specified before placing order to the suppliers;
c) there shall be a system to check the quality and specifications of
input components that are used in the manufacturing of the final 7.4.3/8.2.4
product;
d) the input components shall be selected based on pre-defined and
7.4.3/8.2.4
documented criteria and undergo verification before usage;
e) there shall be a system to identify and separate the non-conforming
input components and to prevent their unintended use in the 8.3
manufacturing process;
f) there shall be a system to ensure the use of proper instruments and
7.5.1
equipment for the manufacturing process of all products.
8. Responsibility of Management – Measurement, Analysis and Improvement
8.1 Organization shall be led by a management which promotes quality in products and
consistency in processes
a) there shall be evidence of management effort to promote quality &
5.1/5.5.2
safety in all the products;
b) there shall be defined and documented roles and responsibilities for
5.5.1
every member of organization;
c) there shall be documented procedures to monitor and measure the
5.6
d) there shall be records of compliance of all regulatory and/or
5.1
national/state regulations;
e) there shall be a defined procedure to update the requirement of
quality management system, regulatory requirements and product 5.4.2/5.6.1
safety guidelines;
f) there shall be evidence of compliance to the market authorization
5.1/8.2.4
regulations for all the products.
8.2 Organization shall have appropriate and adequate number of audits
a) there shall be documented procedures to conduct audits; 8.2.2
b) audits shall be conducted at specified time intervals by qualified and
8.2.2
competent auditors, independent of the area of their activity;
c) there shall be evidence for the action taken on the recommendations
8.2.2
of the audit findings along with reasons for not taking action (if any);
d) there shall be records of internal and/or external audits of the
processes of the facility and the records are preserved for a 8.2.2
specified time period.
8.3 Organization ensures product safety, reliability and credibility
a) there shall be a documented management policy for preserving and
7.5.5
promoting products quality;
b) there shall be defined and documented procedures to promote
product reliability and reasons for failing product reliability is 8.4
analyzed and recorded;
c) there shall be procedures to educate the existing and new
customers/users of the product, of any changes in the product 7.2.3
quality and safety before or after its sale and/or use;
d) there shall be a procedure to collect, analyze and incorporate
8.2
customer/user feedback in enhancing the product quality;
e) adequate information shall be provided to the customer/user about
scope, limitations and jurisdiction of any legal dispute that may arise 7.2.1
about the product;
f) there shall be a policy to bring to public notice any adverse events or
potentially adverse events that could arise due to manufacturing fault 8.5.1
in the product that are already sold;
g) there shall be a policy to bring to the notice of appropriate national/
state/ regulatory authority, any adverse events or potentially adverse
8.5.1
events that could arise due to manufacturing fault in the product that
are already sold;

h) there shall be a policy to take appropriate permission from national/
state/ regulatory authority, before including a medical device product
for any clinical trial that needs to be conducted to establish the 7.3.6
efficacy of effect of the medical device. Not applicable for clinical
evaluation & investigations;
i) there shall be special instructions for use of the product for special
groups of users like neonates, children, elderly, physically and/or 7.2.3
mentally differently able users of the product;
j) the organization shall have established procedures for incorporating
8.4/ 8.5
continuous quality improvement in the product;
8.4 Assessment and improvement in the Quality Management System
a) there shall be a system for the assessment and improvement of
5.6/8.5
Quality Management System;
b) there shall be a system to collect view, feedbacks and reports on
5.6/ 8.4
performance of Quality Management System;
c) there shall be a system for detection of failures/ non conformities in
8.2.3/8.2.4
Quality Management System;
d) there shall be a system to initiate action to rectify the failures/ non
conformities identified in the Quality Management System and 8.5.2
prevent it’s reoccurrence.

Bibliography
1. ISO 9001 :2008, Quality management systems – Requirements
2. ISO 10002, Quality management -- Customer satisfaction -- Guidelines for complaints

handling in organizations
3. ISO 10012, Measurement management systems - Requirements for measurement

processes and measuring equipment
4. ISO 11134, Sterilization of health care products - Requirements for validation and
routine control- Industrial moist heat sterilization
5. ISO 11135, Medical devices - Validation and routine control of ethylene oxide
sterilization (Corrigendum 1 published 1994)
6. ISO 11137, Sterilization of health care products - Requirements for validation and
routine control- Radiation sterilization (Corrigendum 1 published 1995; Amendment 1
published 2001)
7. ISO 13641, Elimination or reduction of risk of infection related to in vitro diagnostic

medical devices
8. ISO 13683, Sterilization of health care products - Requirement for validation and routine
control of moist heat sterilization in health care facilities
General requirements
Clinical investigation plans
11. ISO 14160, Sterilization of medical devices - Validation and routine control of sterilization
of Single-use medical devices incorporating materials of animal origin by liquid chemical
sterilants
12. ISO 14937, Sterilization of health care products - General requirements for
characterization of a sterilizing agent and the development, validation and routine control
of a sterilizing agent
13. ISO/TR 14969, Medical devices - Quality management systems - Guidance on the
application of ISO 13485:2003

14. ISO 14971, Medical devices - Application of risk management to medical devices
15. ISO 15223-1, Medical devices - Symbols to be used with medical device labels, labeling
and information to be supplied - Part 1: General requirements
16. ISO 19011, Guidelines for quality and/or environmental management systems auditing.

Amendment Sheet
RECORD OF CURRENT STATUS OF THE

Technical Criteria for Certification of Medical Devices
The current status of each page and the history of change of the Technical Criteria for
Certification of Medical Devices are set out below.
Sl. Date Of
Page No. Amendment details
No. Amendment
 Highlighting is used within the text of the Requirements to identify current

amendments with any deleted text shown with a strikethrough.
 Previous amendments or revisions are incorporated into the text. Where text on
an individual page is amended the page will be reissued.
 Each reissued page is identified in the header as a ‘page amendment’ making

reference to the “revision number” and the “revision issue date”.

LABELLING CHECKLIST
REQUIREMENTS FOR MEDICAL DEVICES
A. Information mandatory to be marked on the ‘Unit pack for sale’ of Device.
1. Name / Trade Name of the device.
2. The Name & Address of manufacturer
3. Lot / Batch No.
4. Date of Expiry
5. Indication for single use (if applicable)
6. The word “STERILE” (For Sterile Devices)
7. Caution in event of damage to sterile pack
8. Max. Retail Price
B. If space constraint “unit pack for sale”, the following information is also mandatory
on secondary pack of Device, user/ consumer can be cautioned by use of caution
symbol on the unit pack.
1. Device description
2. Mfg. Lic. No. (if applicable)
3. Date of Mfg.
4. Storage / handling instruction
5. Operating instruction / Instruction for use, where appropriate
6. Method of sterilization (For Sterile Devices)
7. Warning / Precautions & Symbols (if applicable)
8. Customer care –Contact Detail.
Note 1. As far as it is practicable and appropriate, the information needed to identify and use
the device safely should be provided on the device itself, and/or on the packaging for each unit,
and/or on the packaging of multiples devices.

Note 2. As far as practicable and appropriate, the information needed to use the Device safely
to be given on the Device itself and/or on the packaging for each unit or, where appropriate, on
the sales packaging. If individual packaging of each unit is not practicable, the information to be
given in the leaflet/ Information to Use supplied with one or more Devices.
Note 3. Each Device to be accompanied by the information needed to use it safely and
properly, taking account of the training and knowledge of the potential users, and to identify the
manufacturer.
Note 4. Where appropriate, the information should take the form of symbols. Any symbol or
identification colour used must conform to the harmonized Standards. In areas for which no
Standards exist, the symbols and colours must be described in the documentation supplied with
the Device”. Graphical symbol as per ISO 15223 can be used as appropriate for all of above.
Any additional labeling requirement specified in related product standard to be included
appropriately.
Note 5. The unit pack can be containing more than one number or type of medical devices.

ESSENTIAL REQUIREMENTS CHECK LIST
Name of Product
PRODUCT GROUP ID: Product:
Group:
Detailed Listing of Products Covered by this Product Group:
Technical
documentatio
Relevant n reference,
Standard, justification
Description of Essential N/A Comply File
reference for claiming
Requirement A Y/N Location
number, date, compliance,
clause comments
and
mitigations
I GENERAL REQUIREMENTS
1 The device must be designed &

manufactured in such a way that,
when used under the conditions &
for the purposes intended, they
will not compromise the clinical
condition or the safety of patients,
or the safety & health of users or,
where applicable, other persons,
provided that any risks which may
be associated with their use
constitute acceptable risks when
weighed against the benefits to
the patient and are compatible
with a high level of protection of
health & safety.
This shall include:
— reducing, as far as possible,

the risk of use error due to the
ergonomic features of the device
and the environment in which
the device is intended to be used
(design for patient safety), and
— consideration of the technical
knowledge, experience,
education and training and where

applicable the medical and
physical conditions
of intended users (design for lay,
professional, disabled or other
users).
2 The solutions adopted by the

manufacturer for the design &
construction of the devices must
conform to safety principles, taking
account of the generally
acknowledged state of the art.
In selecting the most appropriate
solutions, the manufacturer must
apply the following principles in
the following order:
- eliminate or reduce risks as far
as possible (inherently safe design
& construction)
- where appropriate take adequate
protection measures including
alarms, if necessary, in relation to
risks that cannot be eliminated,
- inform users of the residual risks
due to any shortcomings of the
protection methods adopted.
3. The devices must achieve the

performance intended by the
manufacturer and be designed,
manufactured & packaged in such
a way that they are suitable for
one or more of the functions
referred to in Article 1(2)(a) as
specified by the manufacturer.
4 The characteristics &

performances referred to in
sections 1,2 & 3 must not be
adversely affected to such a
degree that the clinical condition &
safety of the patients &, where
applicable, of other persons are
compromised during the lifetime of
the device as indicated by the
manufacturer, when the device is
61
subjected to the stresses which
can occur during normal
conditions of use.
5 The devices must be designed,

manufactured & packed in such a
way that their characteristics &
performances during their
intended use will not be adversely
affected during transport & storage
taking account of the instructions
& information provided by the
manufacturer.
6 Any undesirable side effects must

constitute an acceptable risk when
weighed against the performances
intended.
6a Demonstration of conformity with

the essential requirements must
include a clinical evaluation in
accordance with Annex X.
II REQUIREMENTS REGARDING
DESIGN & CONSTRUCTION
7 Chemical, physical & biological
properties
The devices must be designed &
7.1 manufactured in such a way as to
guarantee the characteristics &
performances referred to in
Section I on the "General
Requirements". Particular
attention must be paid to:
- choice of materials used,
particularly as regards toxicity and,
where appropriate flammability;
- the compatibility between the
materials used and biological
tissues, cells & body fluids, taking
account of the intended purpose of
the device;
- Where appropriate, the results
of biophysical or modeling
research whose validity has been
62
demonstrated beforehand.
7.2 The devices must be designed,

manufactured & packed in such a
way as to minimise the risk posed
by contaminants & residues to the
persons involved in the transport,
storage & use of the devices & to
the patients, taking account of the
intended purpose of the product.
Particular attention must be paid
to the tissues exposed & the
duration & frequency of the
exposure.
7.3 The devices must be designed &

manufactured in such a way that
they can be used safely with the
materials, substances & gases
with which they enter into contact
during normal use or during
routine procedures; if they are
intended to administer medicinal
products they must be designed &
manufactured in such a way as to
be compatible with the medicinal
products concerned according to
the provisions and restrictions
governing those products and that
their performance is maintained in
accordance with the intended use.
7.4 Where a device incorporates, as

an integral part, a substance
which, if used separately, may be
considered to be a medicinal
product as defined in Article 1 of
Directive 2001/83/EC and which
is liable to act upon the body with
action ancillary to that of the
device, the quality, safety and
usefulness of the substance must
be verified by analogy with the
methods specified in Annex I to
Directive 2001/83/EC.
For the substances referred to in
63
the first paragraph, the notified
body shall, having verified the
usefulness of the substance as
part of the medical device and
taking account of the intended
purpose of the device, seek a
scientific opinion from one of the
competent authorities designated
by the Member States or the
European Medicines Agency
(EMEA) acting particularly
through its committee in
accordance with Regulation (EC)
No 726/2004 (1) on the quality
and safety of the substance
including the clinical benefit/risk
profile of the incorporation of the
substance into the device. When
issuing its opinion, the competent
authority or the EMEA shall take
into account the manufacturing
process and the data related to
the usefulness of incorporation of
the substance into the device as
determined by the notified body.
Where a device incorporates, as

an integral part, a human blood
derivative,
the notified body shall, having
verified the usefulness of the
substance as part of the medical
device and taking into account
the
intended purpose of the device,
seek a scientific opinion from the
EMEA, acting particularly through
its committee, on the quality and
safety of the substance including
the clinical benefit/risk profile of
the incorporation of the human
blood derivative into the device.
When issuing its opinion, the
EMEA shall take into account the
64
manufacturing process and the
data related to the usefulness of
incorporation of the substance
into the device as determined by
the notified body.
Where changes are made to an

ancillary substance incorporated
in a device, in particular related to
its manufacturing process, the
notified body shall be informed of
the changes and shall consult the
relevant medicines competent
authority (i.e. the one involved in
the initial consultation), in order to
confirm that the quality and safety
of the ancillary substance are
maintained. The competent
authority shall take into account
the data related to the usefulness
of incorporation of the substance
into the device as determined by
the notified body, in order to
ensure that the changes have no
negative impact on the
established
Benefit / risk profile of the addition
of the substance in the medical
device.
When the relevant medicines

competent authority (i.e. the one
involved in the initial consultation)
has obtained information on the
ancillary
substance, which could have an
impact on the established
benefit/risk profile of the addition
device, it shall provide the notified
body with advice, whether this
information has an
impact on the established
benefit/risk profile of the addition
65
device or not. The notified body
shall take the updated scientific
opinion into account in
reconsidering its assessment of
the conformity assessment
procedure.
7.5 The devices must be designed N/A - - - -

and manufactured in such a way
as to reduce to a minimum the
risks posed by substances
leaking from the device. Special
attention shall be given to
substances which are
carcinogenic, mutagenic or toxic
to reproduction, in accordance
with
Annex I to Council Directive
67/548/EEC of 27 June 1967 on
the approximation of laws,
regulations and administrative
provisions relating to the
classification, packaging and
labelling of dangerous
substances (1).
If parts of a device (or a device

itself) intended to administer
and/or remove medicines, body
liquids or other substances to or
from the body, or devices
intended for transport and storage
of such body fluids or substances,
contain phthalates which are
classified as carcinogenic,
mutagenic or toxic to
reproduction, of category 1 or 2,
in accordance with Annex I to
Directive 67/548/EEC, these
devices
must be labeled on the device
itself and/or on the packaging for
each unit or, where appropriate,
on the sales packaging as a
66
device containing phthalates.
If the intended use of such

devices includes treatment of
children or
treatment of pregnant or nursing
women, the manufacturer must
provide a specific justification for
the use of these substances with
regard to compliance with the
essential requirements, in
particular of this paragraph, within
the technical documentation and,
within the instructions for use,
information on residual risks for
these patient groups and, if
applicable, on appropriate
precautionary measures.
7.6 The devices must be designed &

reduce as much as possible, risks
posed by the unintentional ingress
of substances into the device
taking into account the device &
the nature of the environment in
which it is intended to be used.
8 Infection & microbial

contamination
8.1 The devices & their manufacturing

processes must be designed in
such a way as to eliminate or
reduce as far as is possible the
risk of infection to the patient, user
& third parties, the design must
allow easy handling and, where
necessary, minimise
contamination of the device by the
patient or vice versa during use.
8.2 Tissues of animal origin must

originate from animals that have
been subjected to veterinary
controls & surveillance adapted to
67
the intended use of the tissues.
Notified Bodies shall retain
information on the geographical
origin of the animals.
Processing, preservation, testing
& handling of tissues, cells &
substances of animal origin must
be carried out so as to provide
optimal security. In particular,
safety with regard to viruses &
other transmissible agents must
be addressed by implementation
of validated methods of elimination
or viral inactivation in the course of
the manufacturing process.
8.3 Devices delivered in a sterile state

must be designed, manufactured
and packed in a non-reusable
pack and/or according to
appropriate procedures to ensure
that they are sterile when placed
on the market & remain sterile,
under the storage & transport
conditions laid down, until the
protective packaging is damaged
or opened.
8.4 Devices delivered in a sterile state

must have been manufactured &
sterilised by an appropriate,
validated method.
8.5 Devices intended to be sterilised

must be manufactured in
appropriately controlled (e.g.
environmental) conditions.
8.6 Packaging systems for non-sterile

devices must keep the product
without deterioration in the level of
cleanliness stipulated and, if the
devices are to be sterilised prior to
use, minimise the risk of microbial
contamination. The packaging
system must be suitable taking
68
account of the method of
sterilisation indicated by the
manufacturer.
8.7 The packaging and/or label of the

device must distinguish between
identical or similar products sold in
both sterile and non-sterile
condition.
9. Construction and
environmental properties
9.1
If the device is intended for use in
combination with other devices or
equipment, the whole
combination, including the
connection system must be safe
and must not impair the specified
performance of the devices. Any
restrictions on use must be
indicated on the label or
instruction for use.
9.2 Devices must be designed &

remove or minimise as far as
possible:
- the risk of injury, in connection
with their physical features,
including the volume/pressure
ratio, dimension, and where
appropriate the ergonomic
features,
- risks connected with reasonably
foreseeable environmental
conditions, such as magnetic
fields, external electrical
influences, electrostatic discharge,
pressure, temperature or
variations in pressure and
acceleration,
- the risks of reciprocal
interference with other devices
normally used in the investigations
or for the treatment given,
69
- Risks arising where maintenance
or calibrations are not possible (as
with implants) from ageing of the
materials used or loss of accuracy
of any measuring or control
mechanism.

minimise the risks of fire or
explosion during normal use and
in single fault condition. Particular
attention must be paid to devices
whose intended use includes
exposure to flammable substance,
which could cause combustion.
10. Devices with a measuring

function.
10.1
Devices with a measuring function
must be designed & manufactured
in such a way as to provide
sufficient accuracy & stability
within appropriate limits of
accuracy & taking account of the
intended purpose of the device.
The limits of accuracy must be
indicated by the manufacturer.
10.2 The measurement, monitoring &

display scale must be designed in
line with ergonomic principles,
taking account of the intended
purpose of the device.
10.3 The measurements made by

devices with a measuring function
must be expressed in legal units
conforming to the provisions of
Council Directive 80/181/EEC, as
last amended by Directive
89/617/EEC.
11 Protection against radiation.
11.1 General
70
Devices shall be designed &
11.1.1 manufactured such that exposure
of patients, users & other persons
to radiation shall be reduced as far
as possible compatible with the
intended purpose, whilst not
restricting the application of
appropriate specified levels for
therapeutic & diagnostic purposes.
11.2 Intended radiation
11.2.1 Where devices are designed to

emit hazardous levels of radiation
necessary for a specific medical
purpose the benefit of which is
considered to outweigh the risks
inherent in the emission, it must
be possible for the user to control
the emissions. Such devices shall
be designed & manufactured to
ensure reproducibility & tolerance
of relevant variable parameters.
11.2.2 Where devices are intended to

emit potentially hazardous, visible
and/or invisible radiation, they
must be fitted, where practicable,
with visual displays and/or audible
warnings of such emissions.
11.3 Unintended radiation
11.3.1 Devices shall be designed &

manufactured in such a way that
exposure of patients, users and
other persons to the emission of
unintended, stray or scattered
radiation must be reduced as far
as possible.
11.4 Instructions
11.4.1 The operating instructions for

devices emitting radiation must
give detailed information as to the
71
nature of the emitted radiation,
means of protecting the patient
and the user and on ways of
avoiding misuse & of eliminating
the risks inherent in installation.
11.5 Ionising radiation
11.5.1 Devices intended to emit ionising

radiation must be designed &
ensure that, where practicable, the
quantity, geometry and quality of
radiation emitted can be varied &
controlled taking account of the
intended uses.
11.5.2 Devices emitting ionising radiation

intended for diagnostic radiology
shall be designed & manufactured
in such a way as to achieve
appropriate image and/or output
quality for the intended medical
purpose whilst minimising
radiation exposure of the patient
and user.
11.5.3 Devices emitting ionising radiation,

intended for therapeutic radiology
shall be designed & manufactured
in such a way as to enable reliable
monitoring & control of the
delivered dose, the beam type &
energy & where appropriate the
quality of the radiation.
12 Requirements for medical

devices connected to or
equipped with an energy
12.1 source.
Devices incorporating electronic

programmable systems must be
designed to ensure the
repeatability & performance of
these systems according to their
72
intended use. In the event of a
single fault condition (in the
system) appropriate means should
be adopted to eliminate or reduce
as far as possible consequent
risks.
12.1a For devices which incorporate

software or which are medical
software in themselves, the
software must be validated
according to the state of the art
taking into account the principles
of development lifecycle, risk
management, validation and
verification.
12.2 Devices where safety of the

patients depends on an internal
power supply must be equipped
with a means of determining the
state of the power supply.
12.3 Devices where the safety of the

patient depends on an external
power supply must include an
alarm system to signal any power
failure.
12.4 Devices intended to monitor one

or more clinical parameters of a
patient must be equipped with
appropriate alarm systems to alert
the user of situations which could
lead to death or severe
deterioration of the patient's state
of health.

minimise the risks of creating
electromagnetic fields which could
impair the operation of other
devices or equipment in the usual
environment.
12.6 Protection against electrical

risks
73
Devices must be designed &
avoid, as far as possible, the risk
of accidental electric shocks
during normal use & in single fault
condition, provided that the
devices are installed correctly.
12.7 Protection against mechanical

& thermal risks
12.7.1 The devices must be designed

and manufactured in such a way
as to protect the patient & user
against mechanical risks
connected with, for example,
resistance, stability & moving
parts.
12.7.2 The devices must be designed &

reduce to the lowest possible level
the risks arising from vibration
generated by the devices, taking
account of technical progress & of
the means available for limiting
vibrations, particularly at source,
unless the vibrations are part of
the specified performance.
12.7.3 The devices must be designed &

reduce to the lowest possible level
the risks arising from the noise
emitted, taking account of
technical progress & of the means
available to reduce noise,
particularly at source, unless the
noise emitted is part of the
specified performance.
12.7.4 The terminals & connectors to the

electricity, gas or hydraulic &
pneumatic energy supplies which
the user has to handle must be
74
designed & constructed in such a
way as to minimise all possible
risks.
12.7.5 Accessible parts of devices

(excluding any parts or areas
intended to supply heat or reach
given temperatures) & their
surroundings must not attain
potentially dangerous
temperatures under normal use.
12.8 Protection against the risks

posed to the patient by energy
12.8.1 supplies or substances
Devices for supplying the patient
with energy or substances must
be designed & constructed in such
a way that the flow rate can be set
& maintained accurately enough to
guarantee the safety of the patient
& the user.
12.8.2 Devices must be fitted with the

means of preventing and/or
indicating any inadequacies in the
flow-rate which could pose a
danger.
Devices must incorporate suitable

means to prevent, as far as
possible, the accidental release of
dangerous levels of energy from
an energy and/or substance
source.
12.9 The function of the controls &

indicators must be clearly
specified on the devices.
Where a device bears instructions

required for its operation or
indicates operating or adjustment
parameters by means of a visual
system, such information must be
understandable to the user &, as
75
appropriate, the patient.
13 Information supplied by the

manufacturer
13.1 Each device must be

accompanied by the information
needed to use it safely & properly,
taking account of the training &
knowledge of the potential users,
and to identity the manufacture.
This information comprises the
details on the label & the data in
the instructions for use. As far as
practicable & appropriate, the
information needed to use the
device safely must be set out on
the device itself and/or on the
packaging for each unit or, where
appropriate, on the sales
packaging. If individual packaging
of each unit is not practicable, the
information must be set out in the
leaflet supplied with one or more
devices.
Instructions for use must be

included in the packaging for
every device. By way of exception,
no such instruction leaflet is
needed for devices in Class I or
Class IIa if they can be used
completely safely without any such
instructions.
13.2 Where appropriate this information

should take the form of symbols.
Any symbol or identification colour
used must conform to the
harmonised standards. In areas
for which no standards exist, the
symbols & colours must be
described in the documentation
supplied with the device.
13.3 The label must bear the following
76
particulars:
a)the name or trade name and
address of the manufacturer. For
devices imported into the
Community, in view of their
distribution in the Community, the
label, or the outer packaging, or
instructions for use, shall contain
in addition the name and address
of the authorised representative
where the manufacturer does not
have a registered place of
business in the Community;
b) the details strictly necessary to
identify the device and the
contents of the packaging
especially for the users;
(c)where appropriate, the word
‘STERILE’;
d) Where appropriate, the batch
code, preceded by the word "LOT"
or the serial number.
e) where appropriate an indication
of the date by which the device
should be used, in safety,
expressed as the year & the
month;
f) Where appropriate, an indication

that the device is for single use. A
manufacturer's indication of
single use must be consistent
across
the Community;
g) if the device is custom-made,
the words "custom made device"
h) if the device is intended for
clinical investigations, the words
"exclusively for clinical
investigations";
i) any special storage and/or
handling conditions;
j) any special operating
instructions;
k) any warnings and/or
77
precautions to take
l) year of manufacture of active
devices other than those covered
by This indication may be included
in the batch or serial number.;
m) where applicable, method of
sterilisation;
n) In the case of a device within
the meaning of Article 1(4a), an
indication that the device contains
a human blood derivative.
13.4 If the intended purpose of the

device is not obvious to the user,
the manufacturer must clearly
state it on the label & in the
instruction leaflet.
13.5 Wherever reasonable &

practicable, the devices &
detachable components must be
identified, where appropriate in
terms of batches, to allow all
appropriate action to detect any
potential risk posed by the devices
& detachable components.
13.6 Where appropriate, the

instructions for use must contain
the following particulars:
a) The details referred to in 13.3

with the exception of d) and e);
b) the performances referred to in
section 3 & any undesirable side
effects:
c) If the device must be installed
with or connected to other medical
devices or equipment in order to
operate as required for its
intended purpose, sufficient details
of its characteristics to identify the
correct devices or equipment to
use in order to obtain a safe
combination;
d) All the information needed to
78
verify whether the device is
properly installed & can operate
correctly & safely, plus details of
the nature & frequency of the
maintenance & calibration needed
to ensure that the devices operate
properly & safely at all times;
e) Where appropriate, information
to avoid certain risks in connection
with implantation of the device;
f) Information regarding the risks

of reciprocal interference posed by
the presence of the device during
specific investigations or
treatment;
g) The necessary instructions in
the event of damage to the sterile
packaging and, where appropriate,
details of appropriate methods of
re-sterilisation;
h) If the device is reusable,
information on the appropriate
processes to allow reuse,
including cleaning, disinfections,
packaging and, where appropriate,
the method of sterilisation of the
device to be re-sterilised, and any
restriction on the number of
reuses. Where devices are
supplied with the intention that
they be sterilised before use, the
instructions for cleaning &
sterilisation must be such that, if
correctly followed, the device will
still comply with the requirements
in section 1;
If the device bears an indication
that the device is for single use,
information on known
characteristics and technical
factors known to the
manufacturer that could pose a
risk if the device were to be re-
used. If in accordance with
79
Section 13.1 no instructions for
use are needed, the information
must be made available to the
user upon request;
i) Details of any further treatment

or handling needed before the
device can be used (for example,
sterilisation, final assembly, etc);
j) In the case of devices emitting

radiation for medical purposes,
details of the nature, type,
intensity & distribution of this
radiation.
The instructions for use must also

include details allowing the
medical staff to brief the patient on
any contra-indications & any
precautions to be taken. These
details should cover in particular:
k) Precautions to be taken in the

event of changes in the
performance of the device
l) Precautions to be taken as
regards exposure, in reasonably
foreseeable environmental
conditions, to magnetic fields,
external electrical influences,
electrostatic discharge, pressure
or variations in pressure,
acceleration, thermal ignition
sources, etc.
m) Adequate information
regarding the medicinal products
which the device in question is
designed to administer, including
any limitations in the choice of
substances to be delivered;
n) Precautions to be taken against

any special unusual risks related
to the disposal of the device.
80
o) Medicinal substances, or
human blood derivatives
incorporated into the device as an
integral part in accordance with
section 7.4;
p) Degree of accuracy claimed for
devices with a measuring function;
q) Date of issue or the latest
revision of the instructions for use.
Compiled by: Date:
Position:
Approved by: Date:
Position:
81
82
Medical Devices

ICMED (Scheme)
Provisional Approval System for

Certification Bodies

TABLE OF CONTENTS
0 Introduction ............................................................................................... 87
1 Scope ....................................................................................................... 87
2 Criteria for approval .................................................................................. 88
3 Procedure ................................................................................................. 90
4 Fee ........................................................................................................... 91

0. Introduction
0.1 The Certification Bodies (CBs), desirous of operating under the Indian
Certification For Medical Devices (ICMED) Scheme, hereinafter referred to as the
Scheme, shall need to primarily comply with the requirements specified in ISO 17021
and/or ISO17065, as applicable, and the additional requirements prescribed by QCI
and AIMED, as the j o i n t Scheme Owners.
0.2 In order to be formally accredited by the National Accreditation Board for

Certification Bodies (NABCB) as above, the CBs, even if already accredited to ISO
17021 for scope sector 19 a n d / o r ISO 17065, would need to undergo a limited
Office Assessment and a Witness Assessment of an actual audit under the Scheme.
0.3 The CBs would not get a client unless they are approved under the Scheme and
would not be able to offer an audit for witnessing and get the relevant scope
added in their accreditation.
0.4 Further, in order to launch the Scheme, it is necessary that some certification bodies
are available right at the beginning.
0.5 Therefore, it is necessary to establish a procedure for provisional approval of CBs

under the Scheme, till such time they can get the scope added in their
accreditation or get formally accredited from NABCB.
0.6 This document sets out the requirements to be fulfilled by t h e CBs desirous of
operating under the Scheme pending formal accreditation.
0.7 Since initially only management systems based certification is being launched, this
document covers requirements only for such certification bodies and requirements for
product certification bodies shall be added when the relevant certification is launched.
1. Scope
1.1 This document defines the process for Certification Bodies (CBs) to obtain
provisional approval to operate under the Scheme for ICMED 9000 and ICMED
13485 pending formal accreditation for the Scheme by NABCB as per the
prescribed international standard(s).
1.2 This approval shall be valid for a period of one year within which the approved CBs
would have to obtain formal NABCB accreditation.

2. Criteria for Approval
2.1 The CB shall be a legal entity in its economy, or shall be a defined part of a legal
entity, such that it can be held legally responsible for all its certification
activities. A governmental certification body is deemed to be a legal entity on the
basis of its governmental status.
2.2 Accreditation
2.2.1 For ICMED 9000 certification scope, the CB shall hold NABCB accreditation for
QMS certification as per ISO 17021:2011 for IAF Scope 19 covering the scope of
medical devices, NACE (Rev 1.1) DL33.1 and shall have undergone a witness for the
scope in the last 3 years;
2.2.2 For ICMED 13485 scope, the CB shall be accredited for ISO 13485 certification by
NABCB or be accredited for scope DL 33.1 for QMS as per ISO 17021 and in case of
latter, offer the first audit for ISO 13485 for witnessing to NABCB.
2.3 Competence
2.3.1 The CBs auditors for the Scheme shall have the following qualifications and
experience.
(i) A graduate in Bio Technology or degree in Electrical Engineering or Electronics

Engineering or Chemical Engineering or Bio Medical Engineering or Mechanical
Engineering from a University recognized by the Central Government for such
purposes, followed by 2 years’ experience of manufacturing or research or quality
assurance in medical device field.
or
a Graduate in Science, from a University recognized by the Central Government

for such purposes followed by a minimum of 3 years experience in the
manufacturing or quality assurance in medical device field;
or
a Diploma in Engineering or Pharmacy from a Board or Institute recognized by

the Central Government or the State Government, as the case may be, for such
purposes followed with a minimum of four years experience in the manufacturing
or quality assurance of medical device fields;
(ii) Auditor experience - For a first authorization, the auditor shall comply with the

following criteria, which shall be demonstrated in audits under guidance and
supervision:
a) For ICMED 9000 – The auditor shall have gained experience in the entire
process of auditing medical device quality management systems, including
review of documentation and risk management of medical devices,
implementation audit and audit reporting. This experience shall have been
gained by participation as a trainee in a minimum of two audits for a total of at
least 10 mandays under an accredited QMS programme,
b) Additionally for ICMED 13485 - This experience shall have been gained by
participation as a trainee in a minimum of two audits for a total of at least 10
mandays in an accredited ISO 13485 programme,
c) In addition to criteria a) and b) above, the audit team leaders shall have
performed as an audit team leader under the supervision of a qualified team
leader in at least three ISO 9001 audits for ICMED 9000 and ISO 13485 audits
for ICMED 13485.
d) The knowledge and skills for personnel involved with the ICMED 13485
certification as defined in Annexure B of IAF MD 9 shall be applicable.
NOTE: Kindly refer to IAF MD 9 for further guidance for ICMED 13485 auditor
competence and experience requirements.
2.3.2 The CBs may use ISO 9001 auditors who do not have the requisite qualifications as
prescribed above provided they are supported by technical experts (TEs) who meet the
qualifications at 2.3.1 a) and b) above. The time spent by the TE on an audit shall
not be counted in determining the audit time as prescribed under the ‘Certification
Process’ which the CB is expected to spend.
2.4 Publicly available information
2.4.1 The certification body shall maintain a website for providing information about the
Scheme.
2.4.2 The certification body shall maintain and make publicly available information describing
its certification processes for granting, maintaining, extending, renewing, reducing,
suspending or withdrawing certification, and about the certification activities and
geographical areas in which it operates.
2.4.3 The certification body shall make publicly available information about applications
registered and certifications granted, suspended or withdrawn.

2.4.4 On request from any party, the certification body shall confirm the validity of a given
certification.
3. Procedure
3.1 The CB desirous of approval shall apply to QCI in the prescribed format for
approval.
3.2 It shall submit the documents related to auditor competence system and
certification process for the ICMED Schemes along with its application.
3.3 QCI shall designate an assessment team (AT) comprising an assessor for ISO 17021
and a technical expert to assess the competence of the CB for undertaking certification
under the Scheme. The AT shall review the application and the documents
specifically related to the Scheme and undertake an onsite office assessment of 2
mandays (including time of the TE) to verify competence and review certifications done
and submit a report containing both review of documents as well as onsite
findings. Any non-conformities/concerns observed shall be communicated to the CB at
the end of the assessment for necessary action.
3.4 Based on the report, and the action taken by the CB on the non-
conformities/concerns, if any, QCI shall take a decision on granting provisional approval
to the CB.
3.5 The approval shall be for a period of one year within which the CB shall obtain NABCB
accreditation as needed under the Scheme.
3.6 During the validity of approval, QCI shall undertake at least one witness
assessment to confirm the CB’s competence until it obtains NABCB accreditation.
3.7 The approval shall be subject to suspension/withdrawal with due notice of 15 days in
the event of any non- compliance to the requirements of the Scheme or if the NABCB
accreditation for ISO 17021 is suspended/withdrawn.
3.8 The approved CB shall inform QCI without delay about any significant changes
relevant to its approval, in any aspect of its status or operation relating to;
a) Its legal, commercial, ownership or organizational status,
b) The organization, top management and key personnel
c) Main policies
d) Resources and premises
e) Scope of approval, and

f) Other such matters that may affect the ability of the CB to fulfil requirements for
approval.
QCI shall examine such information and decide on the issue on merits with or without
an on-site verification.
4. Fee
4.1 The following fee structure shall apply:
Application fee Rs. 10,000/-
Man-day charges Rs. 20,000/- per man day
Travel / stay On actuals
Corrective actions review Charges – shall be charged after one round of review based
on extent of review required
4.2 QCI at its discretion may revise/levy any other fee necessary with due notice to the
CBs.

Medical Devices

ICMED (Scheme)
Requirements for Certification Bodies

TABLE OF CONTENTS
0 Introduction ............................................................................................... 97
1. Scope and Purpose .................................................................................. 97
2. General requirements ............................................................................... 99
3. Structural Requirements ......................................................................... 111
4. Resource related and team competence requirements ......................... 113
5. Certification Document ........................................................................... 117
6. Complaints and appeals handling system .............................................. 117
7. Management system requirements ........................................................ 118

0. Introduction
0.1 Quality Council of India (QCI), India’s apex quality facilitation and national
accreditation body, and the Association of Indian Medical Device Industry
(AIMED) have signed an MoU on 30 October 2014 to develop and operate
voluntary certification programmes for Medical Devices in order to enable
medical device industry to demonstrate adherence to the best international
standards and enhance its credibility in the world market.
While QCI and AIMED are the joint Scheme owners, the governing structure of
the initiative is under a multi stakeholder Steering Committee and the initiative
would be operated on a non-profit but self-sustaining basis. It would have a
defined consensus based technical criteria laid down for the medical devices
which would be evaluated by competent third party certification bodies. To
identify the competence of certification bodies’ auditors for evaluation of technical
criteria as devised and certification process, a multi stakeholders Certification
committee is being formed. Certification bodies in turn would be accredited by
the National Accreditation Board for Certification Bodies (NABCB), which is
part of the international system of equivalence of accreditations and
certifications, as per appropriate international standards.
0.2 The manufacturing facility requiring certification under this Indian Certification for
Medical Devices (ICMED) Scheme is required to be certified ultimately by an
NABCB accredited Certification Body duly approved by the Quality Council of
India, as the joint Scheme owner, and complying with the requirements as
specified under this Scheme. The requirements that the Certification bodies need
to comply with for getting approved by QCI under this Scheme are detailed in this
document.
0.3 Initially, certification bodies would need provisional approval under the Scheme
the system for which is described in the document Provisional Approval System
for Certification Bodies separately.
1. Scope and Purpose
1.1 This document specifies the “QCI – AIMED Voluntary initiative on medical
devices” here in after known as Indian Certification for Medical Devices
(ICMED) Scheme, specific additional requirements that the certification bodies

need to fulfil in order to be accredited by NABCB for the ICMED Scheme
operated by the Quality Council of India.
1.2 The certification bodies approved under the ICMED Scheme shall be able to offer
the certification for the following levels;
a) ICMED 9000 - ISO 9001 requirements plus additional requirements

specified under the Scheme
b) ICMED 13485 - ISO 13485 requirements plus additional requirements

specified under the Scheme
c) ICMED 13485 Plus, ICMED 13485 plus product specification as per

MoHFW’s Technical specifications
1.3 In order to be able to offer certification the certification bodies shall need to be
accredited by NABCB as per the following requirements:
1.3.1 For offering certification for ICMED 9000 and ICMED 13485, the certification
body shall need to be accredited as per ISO 17021:2011 for ISO 9001 and ISO
13485 respectively read with additional requirements specified in this document
by NABCB.
1.3.2 The certification body shall have been witnessed for ICMED 9000 and/or ICMED
13485 audit, as applicable, by NABCB.
1.3.3 For certification to ICMED Plus, the certification body shall need to be accredited
against ISO 17021:2011 for ISO 13485 and ISO 17065: 2012 with additional
requirements specified in this document and shall have undergone a witness
assessment by NABCB in last one year one year in scope sector 19 (DL33.1) for
ISO 9001 and ISO 13485 .
1.3.4 However if above criteria in 1.3.1 & 1.3.2 is not met then a certification body can
be granted a provisional QCI approval for Medical Devices Certification as per
Provisional Approval System for Certification Bodies, for a period of one year
subject to condition that certification bodies gets accredited by NABCB as per
1.3.1 & 1.3.2 above..
1.3.5 For being able to offer Medical devices Certification for ICMED 13485 Plus, the
certification bodies shall need to be accredited against ISO 17065:2012 for the

additional requirements specified in this document and requirement as specified
in 1.3.3 above.
1.4 The requirements prescribed in this document are additional requirements that
the certification body shall fulfil. Irrespective of which scheme (refer clauses 1.3
and 1.4 of this document) the certification body opts for, the requirements
mentioned in each clause, whether they pertain to ISO 17065: 2012 or ISO
17021: 2011, shall apply.
2. General Requirements
2.1 Legal and Contractual Matters
2.1.1 In addition to the requirements as specified in the respective accreditation

standards (clauses 4.1 of ISO17065:2012 and clauses 5.1 of ISO 17021:2011)
following requirements shall apply:
2.1.2 Certification agreement
2.1.2.1 The certification body shall ensure that its certification agreement requires
that the client comply with the following requirements in addition to those
specified in the respective standards as above:
a) Always fulfill the certification requirements including product requirements as

specified in the ICMED 9000, ICMED 13485 and ICMED 13485 Plus criteria
documents, the certification processes described in the documents “Indian
Certification for Medical Device Scheme Certification Process for Systems
Certification” and “Indian Certification for Medical Device Scheme Certification
Process for Product Certification”, the requirements specified in this
document, as applicable, and the changes in them as communicated by the
certification body from time to time;
b) The certified manufacturing facility and its processes always fulfils the
certification requirements;
c) The liability on account of non-conforming processes/ products shall rest with

the certified manufacturing facility.
d) The client makes all necessary arrangements for the conduct of the initial and
recertification onsite audit/evaluation, surveillance onsite audits/evaluations
(announced and unannounced), onsite special/short notice audits/evaluations
for the purpose of complaints investigation, etc. It shall also include provision
for examining documentation and records, and access to the relevant
equipment and facilities, products, location(s), area(s), personnel, and client's
subcontractors, as needed;
e) The client shall make claims regarding certification only in respect of the
location and the scope for which certification has been granted;
f) The client shall endeavor to ensure that no certificate or report or any part
thereof is used in a misleading manner;
g) Keeps a record of all complaints made known to the client relating to the
compliance with certification requirement and to make these records available
to the certification body for its verification. The client shall also agree to take
appropriate action with respect to such complaints and any deficiencies found
in products/process in accordance with the requirements of the Scheme;
h) The client shall inform the certification body, without delay, of matters that
may affect its ability to conform to the certification requirements. These shall
include changes in the:
i. Legal, commercial, organizational status or ownership, including any

changes in its licensing status for medical device manufacturing and the
Memorandum of Association/Charter having any bearing on medical
device manufacturing
ii. Organization and management (e.g. key managerial, decision-making or

technical staff),
iii. Contact address and production sites/premises,
iv. Modifications in processes or the production methods, changes in

manufacturing/testing equipment and in the internal control measures
which are significant in nature.
v. Any other information indicating that the manufacturing facility may no

longer comply with the requirements of the certification criteria and the
certification scheme.

2.1.2.2 Records kept by the client in respect of the complaints received and their
resolution shall be verified by the certification body during the surveillance
visits to the client’s premises.
2.1.2.3 The client shall agree for re-audit/evaluation by the certification body as per
the requirement of the certification scheme, in the event of changes
significantly affecting its capability to comply with the requirements of the
certification scheme.
2.1.2.4 The client shall also agree for re-evaluation by the certification body, in the
event of changes in the standards to which compliance of the manufacturing
facility is certified.
2.1.2.5 In addition to the requirements as specified above the requirements specified

vide clauses 2.5 (confidentiality) shall also be part of the agreement with the
client.
2.1.3 Use of licence, certificate and marks of conformity - In addition to the

requirements as specified in the respective accreditation standards (clause
4.1.3 of ISO17065:2012 and clause 8.4 of ISO 17021:2011) following
requirements shall apply:
2.1.3.1 The certification body shall document clear instructions to clients regarding
appropriate use of certification mark(s)/certificate(s) and for providing
information about their certification status. It shall also identify the aspects
that would be considered as misleading and unauthorised as relevant to the
relevant certification scheme. The certification agreement shall make
appropriate cross references to the above document, so as to make it legally
binding. Only in case of ICMED 13485 plus, the mark(s) shall be used to
imply that the medical device/product is certified.
2.1.3.2 In case the certification body operates more than one product/process
certification schemes, then it may document a procedure specifying generic
requirements common to all schemes and in line with the requirements of
ISO 17021:2011 and ISO 17065:2012 and additional section with specific
requirements as specified for the ICMED scheme.
2.1.3.3 The certification body shall ensure that the certificate is used only with
reference to specific manufacturing facility. Accordingly the Certification Mark
shall be put on the product (also refer Labelling guidelines) carrying
reference to the supplies made by the certified manufacturing facility and
shall carry the following information as minimum:
a) Certification Mark
(Under certification mark, CB’s identification by way of its accreditation no.

as given by NABCB, , and certificate no. will be marked)
b) CB Logo (Optional)
2.1.3.4 Certification mark shall be put only on the products included in the scope of
certification as mentioned on the certificate issued by certification body.
2.1.3.5 The certification body shall have documented procedures for the measures to
be adopted in case of non-compliances to specified requirements with
respect to use of certification mark, misuse, including false claims as to
certification and false use of certification body logo and these shall be part of
its agreement with the certified manufacturing facility. The procedure shall
include the process steps and the actions (including penal actions as
relevant), the certification body intends to take in the event of observing
misuse/misleading use of “ICMED certification” certificates and certification
marks.
2.1.3.6 The certification body shall ensure that the applicants are not misusing the
certification mark.
2.2 Impartiality related requirements – In addition to the requirements as specified

in clauses 4.2 ISO17065:2012 and clauses 5.2 of ISO 17021:2011, following
requirements shall apply. The requirements as specified above are applicable to
the schemes as specified in clause 1.2 of this document.
2.2.1 The top management’s commitment to impartiality shall be demonstrated

through:
a) Documenting the certification body’s policy on safeguarding impartiality and

ensuring that it is understood at all levels of the organization. Implementing
good practices like establishing “Code of Conduct” and requiring internal and
external personnel to abide by it.

b) Having a defined institutional structure and impartiality policy and procedures,
appropriate implementation of these policy and procedures and operation and
conduct of its activities and personnel.
c) Having a system that ensures appropriate management of conflict of interest

for ensuring objectivity of its certification functions.
d) Taking action to respond to any threats to its impartiality arising from the
actions of other parts of the organization, persons outside of the organization,
subcontractors, related bodies or other bodies or organizations.
e) Maintaining a professional environment and culture in the organization that

supports a behaviour of all personnel that is consistent with impartiality.
f) Making available to public through its website, its policy on impartiality.
2.2.2 The certification body shall not have any relationship with the client except third
party conformity assessment. There shall be a minimum separation of 2 years
before application can be entertained, in case the certification body has had a
relationship with the client which is generic in nature, for example, internal audit,
in house training, etc. In cases where the relationship pertained to medical
devices specific (design/ processes/product/packaging & labelling/ marketing
related) activities, then the certification body shall carry out impartiality risk
analysis before entertaining the application. The purpose of the risk analysis shall
be to ascertain if longer separation than two years is required from the last date
of end of relationship as stated above or that the risk is of such unacceptable
level so as to prohibit certification by the certification body. Based on the risk
analysis, appropriate decision shall be taken and the justification for the same
shall be recorded.
2.2.3 Although, testing is considered as a conformity assessment activity, in case the

certification body (the legal entity) also has a laboratory and if the manufacturing
facility it has certified/intends to certify, has a contract/arrangement for getting its
raw material and products samples, as per the frequency described in the
relevant standards/ customer requirements, tested in its lab, then this is
considered as an unacceptable threat to impartiality. In such cases, the
certification body shall not certify such manufacturing facility. This provision shall
also be applicable if the laboratory is a separate business unit within same legal

entity as the certification body as well as if the lab belongs to a related body (a
separate legal entity).
Note – Definition of Related Body is based on the relationships as described in

Note under clause 5.2.2 of ISO 17021:2011.
2.2.4 The requirement in 2.2.3 above is not applicable in case the manufacturing
facility uses a number of laboratories by rotation or otherwise. If the certification
body and its client are both part of government, the the two bodies shall not
directly report to a person or group having operational responsibility for both. The
certification body shall, in view of the impartiality requirement, be able to
demonstrate how it deals with a case where both itself and its client are part of
government. The certification body shall demonstrate that the applicant receives
no advantage and that impartiality is assured.
2.2.5 When a relationship poses an unacceptable threat to impartiality then

certification shall not be provided. Some of these situations requiring prohibitions
as mitigation measures have been described vide clause 4.2.6 of ISO
17065:2012 and clause 5.2 of ISO 17021:2011. These shall be implemented
together with the additional ones provided in this document.
2.2.5.1 In case the related body (see note under clause 2.2.3 of this document) is
engaged in any of the activities as specified in clause 4.2.6 of ISO 17065:2012
or activities like management system consultancy, internal auditing or training,
then certification shall not be provided to the relevant client to whom these
services may have been provided by the related body. There shall be a
minimum separation of 2 years, in case the related body has had relationship
which is generic (not specific) in nature, for example, internal audit, inhouse
training, etc. In cases where the relationship pertained to any services which
were medical device manufacturing specific
(design/processes/product/packaging & labelling/marketing related) activities,
etc, then the certification body shall carry out impartiality risk analysis before
entertaining the application. Purpose of risk analysis shall be to ascertain if,
longer separation than two years is required from the last date of end of
relationship as stated above or that the risk is of such unacceptable level so as
to prohibit certification by the certification body. Based on the risk analysis
appropriate decision shall be taken and the justification for the same shall be
recorded.

2.2.5.2 The certification body shall not certify a manufacturing facility which has
received consultancy for design/processes/product/packaging &
labelling/marketing, internal evaluations/audit or training, where the
relationship between the consultancy organization/individual and the
certification body poses an unacceptable threat to the impartiality of the
certification body. Allowing a minimum period of two years to elapse following
the end of the relationship product consultancy is one way of reducing the
threat to impartiality to an acceptable level however, it shall be considered
based on the nature of services offered.
2.2.5.3 The certification body shall not outsource/subcontract any part of the
certification work, evaluation, marketing, etc, to a legal entity that is engaged in
designing, manufacture, installation, distribution or maintenance of the medical
devices. It shall also not be outsourced to organizations who are engaged in
management system consultancy, internal auditing and training and similar
services to manufacturing facilities.
2.2.6 All certification body personnel, either internal or external, or committees, who
could influence the manufacturing facility certification activities, shall act
impartially and shall not allow commercial, financial or other pressures to
compromise impartiality. Certification bodies shall require personnel, internal
and external, to reveal any situation known to them that may present them or
the certification body with a conflict of interests. These aspects shall be
ensured through a signed agreement between the individuals and the
certification body. Certification bodies shall use this information as input to
identifying threats to impartiality raised by the activities of such personnel or by
the organizations that employ them, and shall not use such personnel, internal
or external.
2.2.7 The certification body’s personnel involved in certification activities shall be

bound by the certification body’s impartiality policy and act impartially in their
work through contractual or employment conditions and assignment conditions
for each evaluation/audit activity. The certification body shall also take an
undertaking with respect to freedom from conflict of interest for every
audit/evaluation assignment allotted to the individuals.
2.2.8 The certification body’s personnel involved in certification activities shall not
provide, while carrying out evaluation/audit, any advice, consultancy or

recommendation to the client on how to address any deficiencies that may be
identified during the evaluation/audit.
2.2.9 The certification body shall require its personnel, internal and external, to report
any situation of influence or pressure from the client that may threaten their
independence in the course of certification activities. Based on such report, the
certification body shall take appropriate actions to ensure its independence in its
certification work.
2.2.10 The certification body shall be responsible for ensuring that neither related
bodies, nor sub-contractors, nor internal or external assessors/auditors operate
in breach of the undertakings that they have given. It shall also be responsible for
implementing appropriate corrective action in the event that such a breach is
identified.
2.2.11 The certification body shall ensure that a conflict of interest analysis is carried out
in accordance with the requirements specified in clauses 4.2.3/4.2.4 of ISO
17065:2012 and clause 5.2.2 of ISO 17021:2011, at least once annually and
whenever a significant change occurs in the CB’s activities, such as changes in
the organizational structure and business activities or of the legal status and
mergers with, or acquisitions of other organizations. This analysis shall be
approved by the impartiality committee (see clause 3.3 of this document)
established by the certification body.
2.2.11.1 Further, where risks to impartiality have been identified as a result of risk
analysis (clause 2.2.11), the certification body shall establish and implement a
documented procedure for mitigation of threats against impartiality. These
shall be through any of the following mitigation means:
a) Not provide certification, since the situation poses unacceptable threat to

impartiality – prohibition. Some of the prohibitions are already stated in the
respective standards (ISO 17065:2012 and ISO17021:2011) and this
document.
b) Carry out the certification in a restricted manner based on disclosures
c) Minimize the risks on the basis of clearly defined control points to ensure
mitigation.

2.3 Liability and financing
2.3.1 In addition to the requirements as specified in clause 4.3 of ISO17065:2012 and

clause 5.3 of ISO 17021:2011, following requirements shall apply. The
requirements as specified above are applicable to all the schemes as specified in
clause 1.2 of this document.
2.3.2 The certification body shall also be able to demonstrate that it has evaluated the
risks arising from its certification activities and that it has adequate arrangements
(e.g. insurance or reserves) to cover liabilities arising from its operations in each
of its fields of activities and the geographic areas in which it operates.
2.3.3 The certification body shall be able to demonstrate that it has a reasonable
expectation of being able to provide and to continue to provide the service in
accordance with its contractual obligations. Certification bodies shall also be able
to provide sufficient evidence to demonstrate its viability, e.g. management
reports or minutes, annual reports, financial audit reports, financial plans, etc.
2.3.4 The means by which the certification body obtains financial support shall be such
to allow the certification body to retain its impartiality.
2.3.5 In addition to the above the certification body shall also demonstrate to the
Impartiality committee, that initially, and on an ongoing basis, commercial,
financial or other pressures do not compromise its impartiality.
2.4 Non-discriminatory conditions
2.4.1 The certification body shall have means of demonstrating compliance to this
requirements of ISO 17065:2012 (clause 4.4), through its policies and
procedures as well as actual practice.
2.4.2 The certification body’s policies and procedures shall ensure that it does not
practice any form of hidden discrimination by speeding up or delaying the
processing of applications.
2.4.3 Certification Fees
2.4.3.1 The requirements as specified in clause 7 of the document “Indian

Certification for Medical Devices - Certification Process” shall apply.

2.4.3.2 The certification body’s fee structure shall be publicly available on its website.
The structure shall provide break up of costs.
2.4.3.3 On request from a specific applicant/client, based on the specific conditions

concerning the applicant, the certification body shall inform the applicable
fees, which shall essentially be derived from the fee structure made publicly
available. It shall not substantially differ from the one available publicly,
unless some plausible justifications are recorded.
2.5 Confidentiality - In addition to the requirements as prescribed in the respective

accreditation standards (clause 4.5 of ISO17065:2012 and clause 8.5 of ISO
17021:2011) following requirements shall apply:
2.5.1 Personnel, including any committee members, contractors, personnel of external

bodies or individuals acting on the certification body's behalf, shall keep
confidential all information obtained or created during the performance of the
certification body's activities. There shall be a mechanism such as obtaining
signed confidentiality agreements, etc, for ensuring the same.
2.5.2 The certification body shall have available and use equipment and facilities that
ensure the secure handling of confidential information (e.g. documents, records).
2.5.3 When confidential information is made available to other bodies (e.g.

accreditation body, agreement group of a peer assessment scheme), the
certification body shall inform its client of this action, in advance, through
agreements, etc.
2.5.4 In case of transfer of certificate or application, when the client decides to move
from one certification body to another certification body, the certification body to
which the client is now moving may ask the previous certification body for
information on the reasons for such movement or the performance of the client
with respect to the certification requirements. The previous certification body
shall be obliged to share this information within a reasonable time, not exceeding
10 days from the date of receipt of the request. Such information shall not be
considered as confidential and the certification body shall inform its client of this
requirement, in advance, through agreements, etc.
2.6 Information Requirements - In addition to the requirements as specified in the

respective accreditation standards (clause 4.6 of ISO17065:2012 and clauses

8.1, 8.3, 8.6 of ISO 17021:2011) and the document “Medical devices
manufacturer Certification Process”, the following requirements shall apply:
2.6.1 Publicly available information
2.6.1.1 Making the information publicly available through the certification body’s
website shall be the only means of meeting this requirement.
2.6.1.2 The following information with respect to Indian Certification for Medical
Devices Scheme shall be made publicly available on the certification body’s
website. The information provided shall be accurate, non-misleading and
where relevant detailed enough for the reader to clearly understand:
a) Information related to the terms and conditions of certification and the use
of certificates/certification mark for ICMED Scheme, as contained in the
Certification Agreement (clause 3 of this document). A description of the
rights and duties of applicants and clients, including requirements,
restrictions or limitations on the use of the certification body's name and
certification mark and on the ways of referring to the certification granted.
b) The CB may also provide any other guidance documents on the certification
criteria for the benefit of the applicant, as long as they are not
advisory/consultative in nature.
c) The certification body shall make publicly available on its website the
information about applications registered and certifications granted,
suspended or withdrawn.
d) On request from any party, the certification body shall provide the means to
confirm the validity of a given certification and the provision for the same
shall be made available on the website.
e) The certification body shall maintain and make publicly available on its
website, a directory of valid certifications under “Indian certification for
Medical devices” scheme that as a minimum shall show the name, relevant
certification criteria, scope and geographical location (e.g. city and country)
and contact details for each applicant and certified client and validity of
certification for the certified clients. Please also see additional requirements
given in the document “Indian certification for Medical devices” Certification

Process (clause 1.3)”, which are required to be placed on the certification
bodies website.
2.6.1.3 The certification body shall also make arrangement for providing and up-dating
of information with respect to status of certified clients. The certification body
shall have procedure for frequent updating of the information on its website.
The responsibilities for ensuring accuracy of the information made available on
the website, ensuring frequent updates, etc shall be documented.
2.6.1.4 The information on complaints handling process and the certification body’s
procedure shall be directly available to the public, without the public having to
go through layers of cross linkages.
2.6.2 Information exchange between a certification body and its clients
2.6.2.1 Information on the certification activity and requirements- The

certification body shall provide and update clients on the following:
a) a detailed description of the initial and continuing certification activity,

including the application, initial audit/evaluation, surveillance
audit/evaluation, and the process for granting, maintaining, reducing,
extending, suspending, withdrawing certification and recertification;
b) the certification criteria for ICMED scheme;
c) information about the fees for application, initial certification and continuing
certification;
d) the certification body's requirements for prospective clients;
e) documents describing the rights and duties of certified clients as well as

obligations on part of the certification body including the changes within
certified manufacturing facility that need to be informed to the certification
body; information on procedures for handling complaints both by the
certification body as well by the certified manufacturing facility, in respect
of complaints against certified facilities and appeals;
2.6.2.2 Based on the changes affecting certification, including those initiated by the
client the certification body shall decide upon the appropriate actions in
accordance with its documented procedure, which shall include any of the
actions as specified in clause 7.10.3 of ISO 17065: 2012, singly or in
combination. Responsibility for deciding about the course of actions to be
taken shall also be documented.
3. Structural requirements
3.1 In addition to the requirements as specified in the respective accreditation

standards (clause 5 of ISO17065:2012 and clause 6 of ISO 17021:2011)
following requirements shall apply:
3.2 Organizational structure and top management
3.2.1 The organization structure shall include structure of the parent body (legal entity)
if separate from the department/division that offers certification. It shall also
include structure of the related departments in relation to the department offering
certification services.
3.2.2 The certification body shall identify and document all related bodies (separate
legal entities) as well as other departments of the same legal entity and their
activities and functions and their relationships with the certification body when
describing its organizational structure. This shall cover all relationships and
related bodies, bodies related to the certification body based on ownership;
governance; management; management personnel; shared resources, finances,
contracts and marketing. The activities of all related bodies shall also be
documented for the purpose of identifying any potential conflict of interest. The
certification body shall also have a system for disclosure and documentation of
the types of activities carried out by its internal and external personnel and
subcontractors in general and in particular regarding the designing of relevant
product/process/service, consultation, internal evaluation/auditing, training, etc.
The above information shall also be used for identification of actual/potential risks
to impartiality.
3.2.3 The identification of responsibilities, however done, shall clearly and

unambiguously reflect the responsibilities for activities/functions as described
vide clause 5.1.3 a) to n) of ISO/IEC 17065:2012 and clause 6.1.2 a) to i) of ISO
17021:2011.
3.2.4 The requirement specified vide clause 5.1.4 of ISO/IEC 17065:2012 shall cover
the Impartiality committee and any other committees, if established by the
certification body for certification scheme development, planning for certification

evaluation (sampling and determination), certification review and decision
making, appeals process, etc.
3.3 Mechanism (Impartiality Committee) for safeguarding impartiality
3.3.1 An Impartiality committee with specific responsibility for safeguarding the

certification body’s impartiality in its certification functions and for ensuring that
the policy on safeguarding impartiality and related procedures and other systems
are effectively implemented shall be the only means of fulfilling this requirement.
The impartiality committee as specified in clause 6.2 of ISO 17021:2011 will fulfil
the requirement as specified in this document.
3.3.2 The Impartiality Committee shall:
a) Assist the certification body in developing the policies relating to impartiality

of its certification activities,
b) Counteract any tendency on the part of a certification body to allow

commercial or other considerations to prevent the consistent objective
provision of certification activities,
c) Advise on matters affecting confidence in certification, including openness

and public perception,
d) Conduct a review, at least once annually, of the impartiality of the audit,

certification and decision making processes of the certification body, and
e) Approve the conflict of interest analysis and the mitigation measures

described in clause 2.2.12 of this document.
Other tasks or duties may be assigned to the committee provided these

additional tasks or duties do not compromise its essential role of ensuring
impartiality.
The composition, terms of reference, duties, authorities, competence of members

and responsibilities of this committee shall be formally documented and
authorized by the top management of the certification
This committee shall meet regularly, at least once a year, and a complete record
of the proceedings of this committee shall be maintained.

3.3.3 The certification body shall ensure that
a) The committee for safeguarding impartiality shall be separated from the

management of the certification body operations and established at the
highest level within the organization, independent of its day-to-day operations.
b) In the composition of the committee, participation of key interested parties

shall be ensured, with a representation of a balance of interests such that no
single interest predominates. Internal or external personnel of the certification
body are considered to be a single interest, and shall not predominate.
c) Its chairman shall be a person independent from and external to the

certification body.
3.3.4 Impartiality Committee meetings may be observed by the Accreditation Body’s

Assessment Teams as part of the Certification body’s accreditation process.
3.3.5 Although every interest cannot be represented in the Committee, a certification

body shall identify and invite significantly interested parties. Such interests may
include: clients of the certification body customers of organizations whose
management systems are certified, representatives of industry trade
associations, representatives of governmental regulatory bodies or other
governmental services, or representatives of non-governmental organizations,
including consumer organizations. The invited representative to impartiality
committee shall be some way related to medical devices field.
4. Resource related and team competence requirements
4.1 In addition to all generic personnel related requirements as specified in clause 6

of ISO17065:2012 and clause 7 of ISO 17021:2011 following specific
requirements shall apply:
4.2 Audit/evaluation team competence
4.2.1 The auditors/evaluators of the certification body carrying out the audit/evaluation
of the manufacturing facility against the criteria as described in clause 1.2 above
shall have all the following qualifications as described below:
(iii) A graduate in Bio Technology or degree in Electrical Engineering or

Electronics Engineering or Chemical Engineering or Bio Medical
Engineering or Mechanical Engineering from a University recognized by
the Central Government for such purposes, followed by 2 years’ experience
of manufacturing or research or quality assurance in medical device field.
or
a Graduate in Science, from a University recognized by the Central

Government for such purposes followed by a minimum of 3 years
experience in the manufacturing or quality assurance in medical device
field;
or
a Diploma in Engineering or Pharmacy from a Board or Institute recognized

by the Central Government or the State Government, as the case may be,
for such purposes followed with a minimum of 4 years experience in the
manufacturing or quality assurance of medical device field s;
(iv) Auditor experience - For a first authorization, the auditor shall comply with
the following criteria, which shall be demonstrated in audits under guidance
and supervision:
a) For ICMED 9000 – The auditor shall have gained experience in the
entire process of auditing medical device quality management
systems, including review of documentation and risk management of
medical devices, implementation audit and audit reporting. This
experience shall have been gained by participation as a trainee in a
minimum of two audits for a total of at least 10 mandays under an
accredited QMS programme,
b) Additionally for ICMED 13485 - This experience shall have been

gained by participation as a trainee in a minimum of two audits for a
total of at least 10 mandays in an accredited ISO 13485 programme,
c) In addition to criteria a) and b) above, the audit team leaders shall

have performed as an audit team leader under the supervision of a
qualified team leader in at least three ISO 9001 audits for ICMED 9000
and ISO 13485 audits for ICMED 13485.
d) The knowledge and skills for personnel involved with the ICMED
13485 certification as defined in Annexure B of IAF MD 9 shall be

applicable.
NOTE: Kindly refer to IAF MD 9 for further guidance for ICMED 13485
auditor competence and experience requirements.
4.2.1.1 The auditor/evaluator involved in offsite documentation review of information

received with the application/ document review before going for onsite
assessment shall have the qualifications as described in clause 4.2.1 of this
document.
4.2.1.2 The certification body may use ISO 9001 auditors who do not have the
requisite qualifications as prescribed above provided they are supported by
technical experts (TEs) who meet the qualifications at 4.2.1 above. The time
spent by the TE on an audit shall be in addition to the audit time as prescribed
under the ‘Certification Process’ which the CB is expected to spend.
4.2.2 One of the auditors/evaluators in the team shall be nominated as the team
leader. The team leader shall be an ISO 9001 TL Auditor for ICMED 9000,
ISO 13485 TL Auditor for ICMED 13485 and ICMED 13485 Plus, qualified as
team leader as per the requirement given in ISO 17021:2011.
4.2.3 The certification body will have a system for qualifying lead auditor/evaluators
for “Indian Certification For Medical devices” scheme, based on experience of
having performed
a) For ICMED 9000 At least three audits/evaluations under the medical

devices manufacturer certification ICMED 9000 scheme. For one time
initial qualification, some other evaluation methods such as audit
experience as team leader in other similar areas, may be used.
b) For ICMED 13485, At least Five audits/evaluations under the medical

devices manufacturer certification ICMED 13485 scheme. For one time
initial qualification, some other evaluation methods such as audit
experience as team leader in other technically similar areas, may be used.
c) For ICMED 13485 Plus, Requirements as described in 4.2.3 (ii) above

Scheme. For one time initial qualification, some other evaluation methods
such as audit experience as team leader in other technically similar areas,
may be used.

4.2.4 While carrying out audit/evaluation of a manufacturer facility for ICMED criteria
requirements as specified, the audit team shall collectively have competence as
specified in clauses 4.2.1 and 4.2.3 above.
4.3 Other certification body personnel as relevant to the Indian certification for
Medical devices scheme - Other certification body personnel involved in the
scheme certification evaluation activities shall have the competence as stated
below:
4.3.1 Application Review personnel – The functions to be carried out by the

personnel involved in review of application review is to confirm the adequacy of
the information provided by the applicant and identification of the deficiencies
observed. Further in case the application reviewer also needs to carry out
mandays estimation and team nomination, the persons involved in application
review process, shall have thorough knowledge of “Indian certification for Medical
devices scheme” requirements as defined in this document and “certification
process” documents, in addition to meeting the requirements specified in the
relevant requirements for application review personnel as specified in
ISO17021:2011. The application review personnel shall be qualified based on
experience of having performed at least three application reviews under the
Indian certification for Medical devices scheme or through any other equivalent
route.
4.3.2 Technical Reviewer – The certification body personnel involved in technical

review function shall have the same requirement as that specified in clause 4.2.1
of this document. The technical reviewer shall also meet the qualification criteria
as specified in the relevant requirements of ISO17021:2011 and shall preferably
be qualified on the basis of demonstrated competence to carry out the review
function say based on experience of having performed at least three technical
reviews under the “Indian certification for medical devices scheme”. The
technical reviewer shall be independent from the audit/evaluation team. Only
person(s) employed by the certification body or on long term (2 – 3 years) full
time contract with the certification body shall be entrusted the responsibility of
technical review functions.
4.3.3 Decision maker - Any authorized person(s) of the certification body,

independent of the persons involved in the evaluation function.

a) The person(s) or committee, who take(s) the decision on granting certification
under the the ICMED scheme, shall have a level of knowledge and
experience sufficient to evaluate the information obtained from the evaluation
process and the review.
b) The technical review and the decision may be completed concurrently by the
same person(s), provided they fulfil the necessary requirements as specified
in clause 4.3.2 above and has been specifically authorized for decision
making functions.
c) Impartiality and absence of conflict of interest shall be ensured before

entrusting the task of certification decision making.
5. Certification Document
5.1 The certificate to be issued to certified manufacturing facility for the options as
specified in clause 1.2 of this document shall be as per the certification document
template as enclosed vide Annex A.
6. Complaints and appeals handling system
6.1 All the requirement as specified in clause 7.13 of ISO 17065:2012, clauses 9.7
and 9.8 of ISO 17021:2011, and those specified in clause 8 of the document ”
ICMED - - Certification Criteria” are applicable. In addition, the requirements
specified below are also applicable.
6.2 In case of complaints related to a certified client and the products manufactured
by the certified client, the examination and evaluation of the complaints shall take
in to consideration the effectiveness and implementation of the client’s applicable
audit criteria (i.e certification level for which client is certified). The process of
establishing validity of the complaint shall generally involve processes like
conduct of additional surveillance activities – visit to certified client’s premises for
special evaluation, testing and evaluation of the manufacturing process as per
implemented system in the manufacturing facility, if necessary. The decisions on
complaint shall then be based on the result of additional surveillance activities.
6.2.1 The certification body’s complaint handling process shall document the actions to
be taken by the certification body as well as the certified client, in case the

complaint is established to be valid and manufacturer’s controls are found to be
non compliant with the specified criteria. Some of these actions/conditions shall
also be included in the certification body’s legally enforceable contract with the
client.
6.2.2 In respect of appeals, the certification body shall ensure that the
individual(s)/committee entrusted with handling of appeal and its resolution/
decision shall be independent of the persons involved in certification related
recommendations and decision and their position in the certification body shall be
such that it shall not be possible to influence their decisions with respect to the
subject of the appeal.
6.2.2.1 The procedure shall also have provision for giving a written statement to
the appellant, of the appeal findings including the reasons for the decisions
reached and also communicating to the appellant about the provision for giving
an opportunity to formally present his case. Based on the presentation made, the
individual or a committee appointed for hearing the case shall take a final
decision on the appeal and a formal notice of the outcome and the end of the
appeal process shall be given to the appellant.
7. Management system requirements
7.1 In addition to the requirements as specified in the respective accreditation

standards (clauses 7.12, 8 of ISO17065:2012 and clauses 9.9, 10 of ISO
17021:2011) following requirements shall also apply:
7.2.1 The certification body shall document its “Indian Certification for Medical device”
scheme specific documentation in accordance with the requirements specified in
the document “Indian certification for Medical device scheme “Certification
Process” and this document, in order to ensure that the certified clients comply
with the requirements specified in ICMED 9000, ICMED 13485 and ICMED
13485 Plus, as applicable.
7.2.2 All applicable requirements of the above document shall be addressed either in a
manual or in a combination of manual and associated operational procedures.
7.3 Requirements with respect to records

7.3.1 Records of Applicant and Clients – The certification (applicants and clients)
related records shall include records for all Organizations, including all
organisations that submitted applications, and all organizations evaluated,
manufacturing facility certified or with certification suspended or
withdrawn/cancelled. Specifically the records shall include the following:
a) Application information and results of application review and mandays

estimation and team competence records;
b) Audit/Evaluation planning including decision on site visits in case of multisite

certification and preparation records, evaluation plans and other related
records;
c) Justification for audit/evaluation time determination/manday estimation
d) Records of initial/surveillance and recertification audit/evaluation reports and

related records;
e) Records of verification of correction and corrective actions;
f) Records of technical review and certification decisions; committee

deliberations and decisions, if applicable;
g) Certification agreement;
h) Certification Documentation including scope of certification;
i) Records of complaints and appeals, and any subsequent correction or

corrective actions;
7.3.2 Other Records – The certification body shall also maintain the following records;
a) Related records necessary to establish the credibility of the certification of

ICMED Scheme, such as evidence of the competence of
auditors/evaluators, technical experts, technical review personnel and
decision makers, etc, as relevant;
b) Any other records as relevant to the ICMED Scheme “Certification Process”,

in order to provide confidence that the scheme requirements were complied
with.

7.4 Internal audit – following additional requirements shall be applicable:
7.4.1 The objectives of the internal audit shall also include verification of fulfilment of
requirements of the additional ICMED scheme specific requirements as specified
in ICMED scheme “Certification Process” and this document.
7.4.2 The audit program shall cover all applicable elements of ISO 17065:2012 and
ISO 17021:2011 and those specified in ICMED scheme “Certification Process”
and this document.
7.4.3 The internal audit shall be conducted by personnel knowledgeable in certification,

auditing and the requirements of ISO 17065:2012 and ISO 17021:2011 and the
scheme specific requirements as specified in “ICMED scheme “Certification
Process” and this document.
7.4.4 The internal audit report shall clearly report both the compliance (to the
requirements specified vide clause 7.4.1 above and the certification bodies own
systems) aspects as well as the observed gaps (non-conformities), areas for
improvement, along with the objective evidences to support the conclusions
drawn.

Annexure A Name and Logo
Certificate No............... of the CB
Size not to exceed
This is to certify that 3.5cm x 3.5 cm
Company’s Name
Company’s Address ICMED – Approval Code
has been assessed and is in

compliance with the requirements of
Indian Certification for Medical

devices Certification Scheme
(ICMED) for
ICMED 9000
ICMED 13485
ICMED 13485 PLUS
(Medical device name)
The Scope of
Certification:_________________________ ICMED 9000
____________________________________ LOGO
ICMED 13485
This certificate, valid from dd/mm/yy until LOGO
dd/mm/yy, is subject to satisfactory continued
compliance by the producer to the requirements
for certification and is subject to stipulated
Surveillance visits1. ICMED 13485
Plus LOGO
Authorised by:
LOGOS and criteria as applicable
Certification Manager
(Full Details including office address)
1
The current status of certification is available on www. (CB and QCI website
www.qcin.org).

Medical Devices

ICMED (Scheme)
Certification Process for Systems

Certification

TABLE OF CONTENTS
0 Scope ..................................................................................................... 127

1 Application for Certification ..................................................................... 127
2 Audit Programme.................................................................................... 131
3 Certification Audit Planning .................................................................... 132
4 Certification Audit ................................................................................... 133
5 Certification Decision .............................................................................. 137
6 Certificate ............................................................................................... 137
7 Surveillance Audits ................................................................................. 138
8 Suspension ............................................................................................ 139
9 Renewal of Certification .......................................................................... 139
10 Withdrawal ............................................................................................. 141
11 Change of Location / Ownership / Name ................................................ 141
12 Complaints and appeals ......................................................................... 142
13 Fee ......................................................................................................... 143

0 Scope
0.1 This document describes the certification process to be followed by the Certification
Bodies approved under the Indian Certification for Medical Devices (ICMED) Scheme in
processing applications received from medical devices manufacturers for certification as
per criteria specified under the Scheme.
0.2 Types of Certification -The following levels of certification shall be available:
a) ICMED 9000 Certification which is as per the requirements of ISO 9001 read with the
additional requirements prescribed under the Scheme in ICMED 9000.
b) ICMED 13485 which is as per the requirements of ISO 13485 read with the additional
requirements prescribed under the Scheme in ICMED 13485
c) Certification of medical devices as per specifications developed by the National

Health Systems Resource Centre (NHSRC) of the Ministry of Health & Family Welfare in
addition to the requirements of the above levels – this level is still under development
0.3 The certification shall be granted for each manufacturing facility/premises after due
verification of compliance to the prescribed criteria.
NOTE: Plant, Unit, Manufacturing facility, Medical device manufacturing facility, Premises,
Manufacturer are interchangeable and all these terms refer to an individual medical
device manufacturing facility.
1. Application for Certification
1.1 Application Form
1.1.1 The manufacturer shall apply in the application from prescribed by the Certification
Body.
1.1.2 The applicant shall clearly indicate the type of certification it is applying for.
1.1.3 The applicant shall provide information about each manufacturing facility to be certified.
1.1.4 The applicant shall clearly indicate if any of the activities covered under the criteria for
certification are being carried out at any premises other than the main premises. This is
to plan and facilitate covering the applicable criteria under the same audit. For example
Design or R &D or Testing or any outsourced processes

1.1.5 The applicant shall specify/list all the activities to be audited and certified. It shall
mention whether all the activities are covered at single or multiple locations/sites. For
multiple sites, overlapping activities, if any shall also be mentioned.
1.1.6 Irrespective of the number of facilities of a manufacturer, to be covered under

certification, each and every manufacturing facility shall be audited for compliance to the
Criteria as applicable.
1.1.7 The applicant shall provide the list of medical devices to be covered under the scope of
certification.
1.2 List of Documents
1.2.1 The applicant shall submit all necessary documents (as per applied criteria) to the
Certification Body (CB) for document review.
1.3 Information for Applicants
1.3.1 The information describing certification processes for granting, maintaining, extending,
renewing, reducing, suspending or withdrawing certification, and geographical areas in
which it operates shall be publicly available on certification body’s website and by other
modes. The information shall include:
a) An Application form;
b) Reference to the Certification Criteria,
c) Procedure for obtaining certification under the ICMED Scheme, a detailed description of
the initial and continuing certification activity, including the application, initial evaluation,
periodic surveillance, evaluations, and the process for granting, maintaining, reducing,
extending, suspending, withdrawing certification and re-certification .
d) List of documents required to be submitted along with the application.
e) Information about the fees for application, initial certification and continuing certification
and policy for the fee
f) Documents describing the rights and duties of applicants/ certified clients, and
g) Information on procedures for handling complaints, feedbacks and appeals.

1.4 Registration of Application
1.4.1 The CB shall respond to all enquiries received from prospective applicant organisations
for certification with complete information for facilitating registration of application, within
7 working days of receipt of the query.
1.4.2 The applicant for certification shall apply to any of the approved Certification Bodies on
the Application format prescribed by the CB, and provide the information as mentioned
in previous clauses and any other information the CB may consider relavant to the
certification process.
1.4.3 The applicant shall declare (in the form of an undertaking in application) whether it has
been an applicant / certified under this Scheme with or by any other certification body,
and if yes then shall provide the previous evaluation reports to the new certification
body. The certification body may verify the information provided by contacting the earlier
certification body.
1.4.4 The prospective applicant for Medical device manufacturer shall along with the
application declare any judicial proceedings relating to its operations, any proceedings
by any Regulatory body or suspension / cancellation / withdrawal of any certification /
approvals under any Regulations or otherwise. Such declaration shall be a part of the
undertaking mentioned in 1.4.3 above.
1.4.5 Certification is granted only against the current relevant certification criteria. The
certification body shall review all applications for the above and ensure the same.
1.4.6 All applications for certification shall be reviewed by the certification body for adequacy
and deficiencies observed, if any, shall be informed to applicant within 7 working days of
receipt of application. Review of applications shall be done by a competent person.
Records of review shall be maintained.
1.4.7 Only complete applications supported with all documents sought shall be accepted and
registered in order of receipt with a unique identification number, acknowledged and
records maintained. Registration shall be done within 7 days of receipt of application or
information in response to the deficiencies communicated as per 1.4.6 above. In case
the applicant discloses any proceedings, suspensions etc as per 1.4.3 above, the
applicant shall not be entertained for a period of one year from the date of conviction,
suspension, withdrawal, deregistration etc.
1.4.8 If the certification of any level under the Scheme has been suspended / cancelled by any
approved CB, the application from such a manufacturer shall not be accepted till
suspension is revoked by the concerned CB or for one year from the date cancellation of

certification. This will be applicable only for the manufacturing facility whose certification
has been suspended/cancelled. However, this will not be applicable to other
manufacturing facilities under same legal entity.
1.4.9 The certifications (ISO 9001 and/ or ISO 13485) by CBs other than IAF MLA signatory
accredited CBs shall not be accepted.
1.4.10 Where manufacturing facility is certified by Certification Bodies accredited by NABCB,

audit related to scheme criteria shall be carried out.
1.4.11 Where the certification (for ISO 9001 and /or ISO 13485) is carried out by IAF MLA
signatory accredited CBs other than NABCB, full audit as per scheme criteria
requirements shall be carried out.
1.4.12 If ISO 9001 and/or ISO 13485 certification of the applicant is under suspension,
application for certification shall not be entertained till the suspension of ISO 9001 and/or
ISO 13485 certification is revoked. In case ISO 9001 and/or ISO 13485 certification of a
manufacturing facility is cancelled by any CB, the application certification Under the
Scheme may be carried out considering manufacturing facility as new client.
1.4.13 The antecedents of the applicants shall be checked in relation to the Scheme.
Applications from manufacturers who have earlier either misused the Certification, or
whose earlier certificate was cancelled because of violation of terms & conditions /
misuse of certification or have been implicated / convicted by the court in relation to their
manufacturing activities, shall not be entertained for a period of one year of conviction /
strictures by the court / cancellation of the certificate by any CB.
1.4.14 Applications from manufacturer found to be misusing the certification while their
application is being processed for grant of certification, shall not be processed any
further, and rejected after a due notice of 15 days. Fresh applications from them shall be
treated as per clause 1.4.13 given above.
1.4.15 Requests for grant of certification from previous applicants as per 1.4.16 (a), (b) &(c) /
expired certificates shall be processed like fresh applications and the entire procedure
for grant of certification shall be adhered to subject to clauses 1.4.8 to 1.4.12 above.
1.4.16 An application shall be rejected or closed under the following conditions;
a) if Initial Evaluation is not carried out within 3 months of registration of application
b) if the entire certification process is not completed within 6 months of registration of

application.

c) If the applicant shows no progress towards completion of corrective actions within 3
months of Initial Evaluation and 6 months of Registration of application.
d) Misuse of certification under the Scheme
e) Evidence of any malpractice
f) Voluntary withdrawal of application.
1.4.17 The application fee, if charged by CB, shall be non refundable.
2. Audit programme
2.1 Audit Programme
Considering the type of the certification sought, the following program shall be followed:
Certification activity ICMD 9001 ICMED 13485
Certification Audit – Stage 1 √ √
Certification Audit – Stage 2 √ √
Surveillance –“Once in a year”, Second surveillance √ √

audit shall be a unannounced audit which shall be
carried out within period of 9 to 12 months from
previous surveillance audit.”
a) For ICMED 9000 and ICMED 13485 the audit cycle shall include
 Initial certification audit in two stages (Stage 1 and Stage 2) as per ISO 17021:2011 ;
and
 Recertification audits (generally 3 months before the end of 3 year validity)
2.2 Sampling of manufacturing facility to be Audited
2.3 Audit Mandays
2.3.1 The mandays required to conduct an effective audit shall be calculated in accordance
with the following Table:

Audit Man-days
Bifurcation of Stage – I (20%) and Stage - II (80%)
Certification activity ICMED 9000 ICMED 13485
Certification Audit/ As per IAF MD 5 As per IAF MD 9

Surveillance/
Recertification Plus Plus
1 man day on Site 1 man day on Site
2.3.2 Time duration shall be calculated for each manufacturing facility and each manufacturing
facility shall be individually audited by CBs
2.3.3 The minimum audit time for each on site audit shall be at least one man-day (8 hrs. per
day) .
2.3.4 Document review, audit preparation and report preparation time shall be additional and
shall be at least one man-day.
3.1 Preliminary information to be provided to the CB
3.1.1 CBs shall inform client regarding documentation to be provided by manufacturing facility
for “Document review” in compliance to scheme criteria requirements as applicable
3.1.2 Before starting the application review, the applicant shall provide the Certification Body
with the documentation in compliance to ICMED 9000 and ICMED 13485 requirements,
as applicable.
3.1.3 Apart from information regarding the equipment and facilities of manufacturing facility
particularly sterilization process, the applicant shall provide information regarding the
plan and frequency of controls carried out on incoming material, production facilities and
testing equipment in order to allow auditors to have a preliminary overview of the
manufacturing facility.
3.1.4 The documentation to be provided shall include the following:
a) Quality Manual – Addressing all the requirements as per criteria document
b) Procedures – (Procedures related to process and general area of operation such as

purchase, H.R. etc)

c) Quality Plan – Addressing controls applied & verification frequency of inspection of
Incoming material, Process controls and and final Product(s) etc.
d) Standard operation procedures/ Work instructions
e) Form and Formats.
3.2 Audit Team
3.2.1 The CB shall appoint an Audit Team having the necessary competences and skills
required to conduct the audit.
Audit Type Audit Team composition
Certification Audit Auditor + Technical Expert (if Auditor is not qualified for medical device
sector)
Surveillance same as above
3.3 Audit Plan
3.3.1 The CB shall ensure that the Audit is conducted during working days in which all
manufacturing and support processes are functional.
3.3.2 No audit shall be planned in case the manufacturing facility is non-operational
3.3.3 The Auditors, if more than one, may conduct part of the audit in parallel being focused
on specific processes/ areas.
3.3.4 All the activities as included in the scope of certification of manufacturing facility such as
design, manufacture, construction, marketing, installation, servicing or supply of the
medical device etc shall be audited irrespective of location.
3.3.5 The audit of the controlling/ head office shall be planned in case it is catering to multiple
manufacturing facilities to verify all the functions of its activities.
4. Certification Audit
4.1 Stage 1 Audit
4.1.1 The stage 1 audit is performed to:
a) Audit the client's management system documentation;

b) Evaluate the client's location and specific conditions and to undertake discussions with
the client's personnel to determine the preparedness for the stage 2 audit;
c) Review the client's status and understanding regarding requirements of the standard, in
particular with respect to the identification of key performance or significant aspects,
processes, objectives and operation of the management system including scheme
requirements;
d) Collect necessary information regarding the scope of the management system,

processes and location(s) of the client, and related statutory and regulatory aspects and
compliance (e.g. quality, environmental, legal aspects of the client's operation,
associated risks, etc.);
e) Review the allocation of resources for stage 2 audit and agree with the client on the
details of the stage 2 audit;
f) Provide a focus for planning the stage 2 audit by gaining a sufficient understanding of
the client's management system and site operations in the context of possible significant
aspects;
g) Evaluate if the internal audits and management review are being planned and
performed, and that the level of implementation of the management system
substantiates that the client is ready for the stage 2 audit.
h) Auditors shall identify personal protective equipment which may be reasonably required
during while auditing processes in stage – 2 audit and report in stage – 1 audit and
ensure availability of the required personnel protective equipment during Stage – 2 audit.
4.1.2 The Stage – I audit shall be carried out by a competent audit team on site to judge the
adequacy of the system to meet requirements of applicable ICMED 9000 and ICMED
13485 criteria. It shall result in a formal report
4.1.3 The stage 1 audit shall be carried out at the client's premises in order to achieve the
objectives..` The CB shall have a defined guideline for the same. (Also Ref IAF MD 2).
4.2 Stage 2 Audit
4.2.1 The Objectives of stage 2 audit shall be to verify compliance to the applicable certification
criteria, regulatory requirements, verification of documents and records, and interviews
with personnel involved in various relevant activities. The stage 2 audit shall be
conducted on site.
4.2.2 .Competence of people at manufacturing facility shall be audited to verify the effective
knowledge QA/ QC and of internal procedures, applicable standards related to medical
device being produced. The competency of the personnel shall be as per applicable
regulation. The requirement is as follows.
“The manufacture & Quality Assurance will be conducted under the active direction and
personal supervision of competent technical staff consisting of at least one person each
for manufacturing & Quality Assurance who is a whole time employee and who is
i) a Graduate in Engineering or Pharmacy from a University recognized by the Central

Government for such purposes and has had at least eighteen month practical
experience in the manufacturing or Quality Assurance of devices after his graduation; or
ii) a Graduate in Science, from a University recognized by the Central Government for
such purposes and has had at least three years practical experience in the
manufacturing or Quality Assurance of devices after his graduation; or
iii) a Diploma in Engineering or Pharmacy from a Board or Institute recognized by the

Central Government or the State Government, as the case may be, for such purposes
and has had at least four years practical experience in the manufacturing or Quality
Assurance of devices after his diploma; or
iv) having a foreign qualification, the quality and content of training of which are
comparable with those specified in clause(i), clause (ii) and clause (iii) above and is
permitted to work as competent technical staff. “
4.2.3 Safety during audits
4.2.3.1 The Audit at medical device manufacturing facility involves risks linked to work
environment. The responsibility for risk analysis and the identification of the most
suitable means of protection is shall be that of the manufacturer..
4.2.3.2 Auditors must have personal protective equipment which may be reasonably required to
while auditing different manufacturing processes of manufacturing facility particularly
sterilization.
4.3 Non conformities
4.3.1 Any non conformities observed during audit, with respect to the certification criteria shall
be informed in writing to the applicant for taking necessary action. The non conformities
shall be classified as Major or Minor depending on their severity.
a) Major Non conformity – A non conformity that affects the capability of the management
system to achieve the intended results. A number of minor NCs on the same aspect
shall be clubbed together and raised as single major NC.

b) Minor Non conformity – All other gaps and non conformities shall be classified as
Minor. These shall generally be related to other implementation issues which do not
directly affect the capability of the management system to achieve the intended results.
4.3.2 In case of major and minor NCs the organization shall carry out root cause analysis and
inform the same along with correction and corrective actions, within a period of one
month or 3 months respectively. All non-conformities are required to be closed before
initial certification through verification of adequacy of the correction and corrective
actions. All Major non-conformities, shall invariably require a follow-up audit.
4.4 Audit Report
4.4.1 The Certification Bodies shall send the Audit Report within 7 working days from the date
of the completion of the audit to the client.
4.4.2 The audit reports for stage 1 and stage 2 shall clearly provide evidence and conclusions
about the fulfilment of the audit objectives as described above and shall contain
sufficient detailed information regarding conformity with all the relevant certification
requirements, including the Certification Criteria. The Certification Body shall develop
appropriate report format(s) and report writing guidance document to ensure that the
report provides, adequate and complete details for ensuring appropriate, evaluation,
review and decision in respect of grant of certification. The Audit report shall have the
following as minimum:
a) Scope of the Certification,
b) Name and address of manufacturing facility (ies) audited
c) Name(s) of auditor/membbers of the team
d) Date & time of audit
e) Audit Criteria
f) Structure of the audited manufacturing facility
g) Report on auditing including that for all “Additional Requirements” with evidence of
compliance
h) Nonconformities, if any
i) Processes excluded by the Scope of the certification, if any,
NOTE: ISO 17022 may be referred to for further guidance on Audit reporting

5. Certification Decisions
5.1 Certification decision shall be the sole responsibility of the certification body and the
decision shall be taken by its internal person(s) competent for the job provided they have
not been involved in the process of audit of the organization. Impartiality and absence of
conflict of interest shall be ensured before entrusting the task of certification decision
making
5.2 Conditions for granting a certificate:
5.2.1 The CB shall grant the certification when all the following conditions are met with:
a) The audit report with suitable recommendation is available
b) All NCs raised have been closed.
c) There are no other issues impacting grant of certification
There shall be no conditional grant of certification.
6. Certificate
6.1 The manufacturer may achieve one of the following certificates:
Certificate Object Extension Certificate Number
Single All the processes Single manufacturing One certificate number

Manufacturing carried out facility
facility
Multi-Site Group of manufacturing Group of One number (the certificate

facilities sharing manufacturing shall have an annexure
common facilities or facilities with the list of certified
processes Manufacturing facilities)
Company Entire company All manufacturing One number per company

facilities (the certificate shall have
an annexure with the list of
certified manufacturing
facilities)

6.2 Certification Documentation - The certificate shall include the following information:
a) Certificate number
b) Certification scheme name
c) Reference to certification criteria
d) Manufacturer’s name (that of the legal entity) with all locations in the schedule
e) Certified Manufacturing facility address
f) Scope of certification
g) Scheme logo
h) logo of the CB
i) Accreditation number with logo
j) Date of certification
k) Expiry date
l) Signature of the CB's authorized representative
In case of company certification, the CB shall annex to the certificate the list of the
certified manufacturing facilities.
6.3 Validity
6.3.1 The certificate shall be valid for 3 years from the date of issue.
7. Surveillance audits
7.1 Surveillance audits, announced and unannounced shall be carried out on site at a
frequency mentioned in clause 2.1, by a competent audit as as per clause 3.2 above.
The audit mandays for surveillance audits shall be as defined in clause 2.3
7.2 Non conformities observed during surveillance audit shall be categorized as major and
minor as defined in clause 3.4.

8. Suspension
8.1 The certification body shall issue instructions to the certified organization for suspension
of certification when
a) the major NCs issued are not closed in timelines prescribed
b) repeated major NCs are raised in consecutive surveillance assessments
c) there is failure to organize a surveillance audit within the specified time period
d) there is non payment of outstanding dues
e) any major changes have taken place in the legal status, ownership, name etc without
prior information to the CB
f) any wilful misuse of the logo of the Scheme is detected
g) any wilful false declaration in the application form or otherwise is detected
h) excessive or serious complaints against the certified organization management system

are received and are found to be valid
i) the certified oranization voluntarily requests a suspension. Such request must be

submitted in writing to the CB along with the reasons. The CB may decide to accept the
request but may not allow the client to revoke suspension on its own.
8.2 The certification body shall issue due notice of at least one week for suspension of
certification to the certified organization.
8.3 When certification is suspended, the certification body shall require that, during the
period of suspension, the certified organization makes no misleading claims.
8.4 The certification body shall revoke suspension only when Corrective actions have been
taken and verified by the certification body.
9. Renewal of certification
9.1 The certification shall be renewed at the expiry of 3 years validity period. However the
renewal process and the renewal of certification decision shall be taken on or before the
certificate expiration date. In order to achieve the same the certification body shall send
the Renewal notice to the certified units at least four months prior to expiry of certificate
validity period.

9.2 The certified organization shall apply for renewal in the prescribed format along with fee,
if any prescribed by the CB at least 3 months before expiry of the certification.
9.3 The onsite surveillance audit conducted towards the end of third year and before the
expiration of the certificate shall be considered as the recertification audit (refer clause
2.3 ). The objectives of this audit will be a combination of stage 2 and surveillance
audits, unless there has been any changes in product and process requirements, which
would then also require assessment of the organization’s revised processes, controls
and systems.
9.4 The certification body shall review the performance of the certified unit who has sought
renewal of the Certificate, with respect to compliance to certification criteria during the
entire certification cycle, prior to a decision on the renewal of the certificate. The review
shall essentially be based on the following:
a) Surveillance and recertification audit reports for the audits carried out during the
certification cycle. The NCs raised and the satisfactory resolution of the issues
raised and their effectiveness.
b) Any suspension of certificate during the previous validity period;
c) corrective actions taken
d) complaints if any received,
e) Adverse information from stakeholders and regulators, if any.
9.5 The review shall be conducted by competent person (s) designated for the job.
9.6 The decision for renewal of certificate shall be taken by the competent personnel
authorised for the same, based on the satisfactory performance of the certified
organization.
9.7 The certification body shall not renew certification with conditions for compliance to be
verified subsequently. There shall be no conditional renewal of certification.
9.8 When performance of the certified unit is not satisfactory, the certification body shall
withhold the renewal of the certificate clearly stating the reasons and give time for
effecting corrective actions. The verification and decision on renewal should be taken
within 3 months of the certification expiry date.
9.9 The corrective actions shall be verified generally on site unless the Certification Body
can verify the same off site prior to considering for renewal of certificate. The justification
for off site review shall be recorded.
9.10 In case the manufacturing unit does not complete satisfactorily actions within three
months, the certificate shall stand expired from the date of expiry of previous validity.
9.11 When a certificate is not renewed, it shall expire at the end of validity period.
10. Withdrawal
10.1 Certification body shall withdraw the certificate when
a) Certified organization contravenes the terms and conditions of certification and

provisions of the ICMED scheme
b) The certified organization is not conforming to the requirements of the Certification

Criteria and the corrective actions taken are not ensuring compliance,
c) the proposed plan for corrective actions will take a considerable time beyond 6 months
for implementation;
10.2 Certification body shall withdraw the certificate at the request of the certified plant, if the
operation(s) in the certified organization can no longer be carried due to reasons of
natural calamities such as flood, fire, earthquake etc, lock out declared by the
management, or closure of business operations etc.
11. Change of location/Ownership/Name
11.1 The certified organization shall inform the CB of any change in the location of the
manufacturing unit.
11.2 On receipt of such information, the certification body shall issue instructions to the
certified organization for suspension of certification with immediate effect.
11.3 The manufacturing unit shall be subject to an onsite audit at the new site like an Initial
audit of an applicant.
11.4 If the audit is satisfactory, the Certification Body shall transfer the Certificate to the new
location.
11.5 The CB shall endorse the change of premises on the Certificate.
11.6 In the event of change of Ownership, the organization shall provide necessary
documentary evidence. The new management of the organization shall submit its
acceptance to the agreement with the Certification Body, and payment of fees. The
same process shall be followed as and when an existing applicant undergoes a change
in management. Such changes shall not call for a visit to the production site.

11.7 In case of change of Name, the manufacturer shall inform the change in the name to the
CB supported with documentary evidence, and if satisfied the CB shall endorse the
Certificate in the new name.
12. Complaints and appeals
12.1 The certification body shall have a documented procedure for handling of complaints
and appeals.
12.2 The procedure for complaint handling shall include complaints from all stake holders,
especially its certified organization as well as customers of its certified organizations..
12.3 The procedure for receipt and handling of complaints shall be made available to public
on the CB’s website and shall also be easily accessible on the website.
12.4 Upon receipt of a complaint or appeal, the certification body shall confirm whether the
complaint or appeal relates to certification activities for which it is responsible and, if so,
shall address it. The certification body shall acknowledge receipt of a formal complaint or
appeal.
12.5 The certification body shall be responsible for gathering and verifying all necessary
information (as far as possible) to progress the complaint or appeal to a decision.
12.6 The procedure shall include the process steps for receiving and recording, evaluating
and establishing validity of the same, investigating and make decisions on complaints
and appeals. The process step shall also include the activities of root cause analysis,
correction and corrective actions.
12.7 If the complaint relates to a certified organization, then the examination and evaluation of
the complaints shall take in to consideration the effectiveness and implementation of the
certified organizations system.
12.8 The CB’s complaint handling process shall document the actions to be taken by the CB
as well as the certified organization,. Some of these actions/conditions shall also be
included in the CB’s legally enforceable contract with the certified organization.
12.9 The certification body shall record and track complaints and appeals, as well as actions
undertaken to resolve them.
12.10 The decision resolving the complaint or appeal shall be made by, or reviewed and
approved by, person(s) not involved in the certification activities related to the complaint
or appeal. To ensure that there is no conflict of interest, personnel (including those
acting in a managerial capacity) who have provided consultancy for a certified
organization, or been employed by the certified organization, shall not be used by the
certification body to review or approve the resolution of a complaint or appeal for that
certified organization within two years following the end of the consultancy or
employment.
12.11 Whenever possible, the certification body shall give formal notice of the outcome and the
end of the complaint process to the complainant.
12.12 In respect of appeals the CB shall ensure that the individual(s)/committee entrusted with
handling of appeal and its resolution decision shall be independent of the persons
involved in certification related recommendations and decision and their position in the
CB shall be such that it shall not be possible to influence their decisions with respect to
the subject of the appeal.
12.13 The procedure shall also have provision for giving a written statement to the appellant, of
the appeal findings including the reasons for the decisions reached and also
communicating to the appellant about the provision for giving an opportunity to formally
present his case.
12.14 Based on the presentation made, the individual or a committee appointed for hearing the
case shall take a final decision on the appeal and a formal notice of the outcome and the
end of the appeal process shall be given to the appellant.
12.15 The certification body shall give formal notice of the outcome and the end of the appeal
process to the appellant.
12.16 The certification body shall take any subsequent action needed to resolve the complaint
or appeal.
13. Fee
13.1 A fee to be charged to the organization for various activities of the certification scheme,
without any discrimination between manufacturing facilities, geographical location, size
of the manufacturing facility.
13.2 The CBs fee structure shall be publicly accessible and also be provided on request. The
fee structure shall provide break up of costs.
13.3 CB shall notify and obtain consent to its fee structure from the organizations prior to
grant of certification. As and when the fee undergoes a change, the same shall be
communicated to all including applicants and the manufacturing facility certified under
this scheme of certification for their acceptance.

onMedicalDevices
2nd Floor, Institution of Engineers Building

2, Bahadur Shah Zafar Marg, New Delhi – 110 002. India
Tel. : 91-11-2337 9321, 2337 8057 Fax 91-11-2337 9621

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QCI-AIMEDVoluntaryinitiative

2nd Floor, Institution of Engineers Building

0.4 The “Indian Certification of Medical Devices (ICMED) Scheme” as it is being

3. Certification of medical devices as per specifications developed by the National

Sl No. Description Page No.

2. Composition of Steering Committee-------------------------------------- 9

3. Composition of Technical Committee------------------------------------ 11

4. Composition of Certification Committee ---------------------------------12

5. Technical Criteria for Certification of

6. Technical Criteria for Certification of

7. Essential Requirement Check Sheet ----------------------------------- 60

8. Provisional Approval of Certification Bodies -------------------------- 83

9 Requirement for Certification Bodies ----------------------------------- 93

10. Certification Process ------------------------------------------------------- 123

3.2 The Steering Committee shall be supported by a Technical Committee and a

4.1.1 Representation of a balance of interests in the Steering Committee such

4.1.2 Key interests should include representatives of regulatory/standards bodies

4.1.5 Representation to individual experts should be given exercising due care in

4.1.6 It is desirable to invite organizations to nominate Principal and Alternate

4.2 Steering Committee: It shall comprise of Government(s), regulatory bodies, medical

4.1.7 SC may coopt any other members.

4.1.8 Quorum - The presence in person, at a meeting of the Steering Committee

4.1.9.2 Receiving recommendations of Technical/Certification Committees and

4.1.9.3 Constituting any other committees, as needed

4.1.10 Meetings - The SC shall meet at least once every year.

4.2.1 TC may coopt any other members subject to reporting to SC.

4.2.3 Terms of reference - The TC is responsible for;

4.2.3.2 Defining the certification criteria, and

4.2.3.3 Resolving any related issues;

4.2.4 Meetings - The TC shall meet at least once every year.

4.3 Certification Committee (CC): It shall comprise of experts from organizations as

4.3.1 Quorum - The presence in person, at a meeting of the Certification Committee

4.3.2 Terms of reference - The CC is responsible for;

4.3.2.1 Developing, maintaining and revising as appropriate the certification process

4.3.2.2 Developing, maintaining and revising as appropriate the requirements for

4.3.2.3 Developing guidance document to assist industry to apply for Certification

4.3.2.4 Designing the Certification Marks, if any

4.3.2.6 Resolving any issue relating to certification

Meetings - The CC shall meet at least once every year.

Dr. Jitendra Kumar Sharma (NHSRC)

Dr. K. K. Kalra National Accreditation Board for Hospitals &

QCI – AIMED Voluntary Initiative on

Indian Certification of Medical Devices

Technical Criteria for Certification of

Issue 1 | March 2016 13

Dr. B.K. Rao The Associated Chambers of Commerce and Industry

Issue 1 | March 2016 14

Sl No. Description Page No.

Technical Committee for QCI – AIMED

Issue 1 | March 2016 15

Issue 1 | March 2016 16

a) needs to demonstrate its ability to consistently provide medical devices that

b) aims to enhance customer satisfaction through the effective application of the

1.3 Text in Italic is in addition to the requirement ISO 9001: 2008

a) ISO 9000, Quality management systems — Fundamentals and vocabulary

b) ISO 9001:2008 Quality Management System - Requirements

Issue 1 | March 2016 17

Issue 1 | March 2016 18

Issue 1 | March 2016 20

Issue 1 | March 2016 21

Issue 1 | March 2016 24

Issue 1 | March 2016 29

1. ISO 8402, Quality management and quality assurance Vocabulary.