GUIDELINES FOR MEDICAL DEVICES IN INDIA
Rishav Kumar*, Dr. Kalpana Nagpal
Amity Institute of Pharmacy, Amity University , Sector-125, Noida, Uttar Pradesh
Email: rshv.kumar@yahoo.com
ABSTRACT
We all have someday been through heavy medical device like MRI or CT scan but may not know that these
devices have certain guidelines under which they give significant results. Modern medical diagnosis and
treatment methods are largely dependent on the medical devices. A medical device improves the quality of the
healthcare but only if used under proper regulation and guidelines otherwise it may create problems. The
current guidelines and laws introduced by central drug standards control organization (CDSCO) will improve
the quality and efficiency of the devices. Drug & cosmetic act and rules enable the quality manufacturing of the
devices, their registration and clinical trials; it helps the user to get accurate results which has direct affect on
the patient care. In present scenario where India is a great market for foreign companies for the import of
expensive devices, the guidelines must be strictly implemented for the correct results by devices. Guidelines
for devices varies depending on the class of device, it becomes stricter for the devices with higher risk. These
guidelines can be further used as the basis of advancements in the device regulations in India.
INTRODUCTION
Now a days medical devices are widely used in all branches of diagnosis, monitoring, medicine, surgery,
treatment and health care. The device industry is a major one, with worldwide sales of more than $521.2 billion
per year. As defined by WHO, an article, instrument, apparatus or machine that is used in the prevention,
diagnosis or treatment of illness or disease, or for detecting, measuring, restoring, correcting or modifying the
structure or function of the body for some health purpose. Typically, the purpose of a medical device is not
achieved by pharmacological, immunological or metabolic means. medical device is defined according to
Schedule M-III creates a specific definition of medical devices as separate from drugs. Unlike a drug, a medical
device is defined as a medical tool “which does not achieve its primary intended action in or on the human
body by pharmacological, immunological, or metabolic means.” Medicinal products covered by the Drugs and
Cosmetics Act (DCA) will not fall under Schedule M-III If there is any uncertainty about whether the product
falls under the drug or medical device category of the DCA under this schedule, regulators will consider the
principal mode of action of the product.
Under the 2017 Rules, medical devices means :
A. Specific devices intended for internal or external use in the diagnosis, treatment, mitigation or prevention of
disease or disorder in human beings or animals which are notified by the government from the time to time
under the Drugs and Cosmetics Act, 1940 (“D&C Act”). Some categories of devices have already been
notified by the government. A list of classes of currently notified medical devices is annexed as Annexure D.
B. Specific substances intended to affect the structure or any function of the human body which are notified by
the government. At present, the substances notified are mechanical contraceptives (e.g. condoms,
intrauterine devices, tubal rings) and disinfectants.
C. Surgical dressings, surgical bandages, surgical staples, surgical sutures, ligatures, blood and blood
component collection bag with or without anticoagulant;
D. Substances used for in vitro diagnosis (referred to in the 2017 Rules as “In Vitro Diagnostic Medical
Device”)
E. All substances intended to be used for or in the diagnosis, treatment, mitigation or prevention of any
disease or disorder in human beings or animals. This is a catch-all category for substances.
RISK BASED CLASSIFICATION
Classification of medical devices under Schedule M-III, medical devices will be divided into four classes
according to their risk level: A, B, C, and D. Class A will include low-risk devices such as thermometers and
tongue depressors. Low- to moderate-risk devices such as hypodermic needles will fall under Class B. Class C
will cover moderate-to high-risk devices such as lung ventilators and bone fixation plates; and high-risk devices
heart valves and implantable defibrillators, for example will comprise Class D. The regulatory procedures for
medical devices will vary according to their class. In general, higher-risk devices will require more regulations
and a more stringent conformity assessment process. The regulatory procedure for medical devices varies
according to their class. The objective of the present study is to provide an overview of Regulatory guidelines
for medical devices are importing, registering, and licensing and clinical trials in India. These new Central Drug
Standard Control Organization (CDSCO) documents may be used as a basis for any future comprehensive
changes in medical device regulations in the country.
Class Risk- Level Device example
A Low-Risk Thermometer, Tongue depressors
B Low-Moderate Hypodermic needles, suction equipment
Risk
C Moderate-High Lung ventilator, bone fixation plate
Risk
D High-Risk Heart valves, implantable defibrillator
Table; The draft schedule M-III, released by Central Drug Standards control Organization (CDSCO) of
India, includes a proposed risk classification for medical devices, based on their intended use.
IMPORTANCE OF MEDICAL DEVICES
Medical devices have extended the ability of physicians to diagnose and treat diseases, making
great contributions to health and quality of life. Implementing a full regulatory programme can be
very demanding on resources, especially for a developing nation. All medical devices will undergo
conformity assessment procedures to ensure compliance with quality and safety standards before
they are allowed on the Indian market. The CLAA will adopt as regulatory standards the Bureau of
Indian Statistics (BIS) and International Organization for Standardization (ISO) specifications for
quality management systems. To meet these standards, medical devices must be designed and
manufactured in a way that achieves their intended purpose and does not compromise patient
health or safety
1. Diagnostic devices: Ultrasound machines, MRI machines, PET scanner, CT scanner, X-ray
machines
2. Monitoring Devices: glucose monitor, Electrocardiograph, Blood pressure monitor, Body weight
monitor
3. Treatment Machines: Infusion pump, medical lasers, LASIK surgery machines
4. Life Supporting Machines: Medical ventilator, Incubator, Anaesthetic machines, Dialysis
machines, ECMO
5. Medical Laboratory equipments: Blood analyzer, urine analyzer, Bench top analyzer, Blood
gas analyzer.
6. Contraceptive Devices: Intra uterine devices, condoms, Diaphragm, Contraceptive sponge.
The Indian medical device market is growing steadily. It was valued at US$3.5 billion in 2015 and could
expand to approximately US $4.8 billion by 2019. As India's economic, healthcare, and social landscapes
evolve, its medical device market emerges as a promising opportunity for foreign manufacturers. Medical
device regulation in India only apply to certain product categories. However, India's underdeveloped
regulatory framework is a significant obstacle for foreign manufacturers of regulated device types. The weak
rupee makes it difficult for some medical device companies to remain profitable in this market, particularly for
manufacturers competing with low-cost Chinese products. Also, foreign manufacturers will also encounter
significant competition from American, European, and Japanese companies.
International Conference at Amity university, 23rd May 2018, Noida , India
STANDARDS
The formal definition of a standard that should be adopted in the medical device domain is given by the ISO:
Standards are documented agreements containing technical specifications or other precise criteria to be used
consistently as rules, guidelines or definitions of characteristics, to ensure that materials, products, process and
services are fit for their purpose. Standards can establish a wide range of specifications for products, processes
and services.
1. Prescriptive specifications obligate product characteristics, e.g. device dimensions, biomaterials, test or
calibration procedures, as well as definitions of terms and terminologies.
2. Design specifications set out the specific design or technical characteristics of a product,
e.g. operating room facilities or medical gas systems.
3. Performance specifications ensure that a product meets a prescribed test, e.g. strength
requirements, measurement accuracy, battery capacity, or maximum defibrillator energy.
4. Management specifications set out requirements for the processes and procedures
companies put in place, e.g. quality systems for manufacturing or environmental management systems.
A standard may contain a combination of specifications. Prescriptive, design and performance specifications have
been commonplace in standards. Management specifications are also rapidly gaining prominence.
Why do we need standards?
Standards can serve different purposes. They can:
3. Provide reference criteria that a product, process or service must meet.
4. Provide information that enhances safety, reliability and performance of products, processes and services.
5. Assure consumers about reliability or other characteristics of goods or services provided in the marketplace.
6. Give consumers more choice by allowing one firm’s products to be substituted for, Or combined with, those of
another.
Types of Standards (CDSCO 2018)
7. Basic Standards or Horizontal Standards: Standards indicating fundamental concepts, principles and
requirements with regard to general safety and performance aspects which are applicable to all kinds or a wide
range of products and/or processes (e.g. standards concerning risk management, clinical investigation and the
quality management system for the manufacture of medical devices.)
8. Group Standards or Semi-Horizontal Standards: standard indicating aspects applicable to families of
similar products and/or processes making reference as far as possible to basic standards (e.g. standards
concerning sterile medical devices, electrically powered medical devices, stability of in vitro diagnostics
reagents)
9. Product Standard or Vertical Standards: Standards indicating necessary safety and performance
aspects of specific products and/or processes, making reference, as far as possible to basic standards and
group standards(e.g. standards for infusion pumps, for anesthetic machines or for blood glucose meter for self-
testing.)
# Essential Principles applicable to all medical devices including IVD medical
devices - General Principles
10. Medical devices should be designed and manufactured in such a way that, when used under the conditions
and for the purposes intended and, where applicable, by virtue of the technical knowledge, experience,
education or training, and the medical and physical conditions of intended users, they will perform as intended
by the manufacturer and not compromise the clinical condition or the safety of patients, or the safety and
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 and safety.
11. The solutions adopted by the manufacturer for the design and manufacture of the devices should conform to
safety principles, taking account of the generally acknowledged state of the art. When risk(s) reduction is
required, the manufacturer should control the risk(s) so that the residual risk associated with each hazard is
judged acceptable. The manufacturer should apply the following principles in the priority order listed: identify
known or foreseeable hazards and estimate the associated risks arising from the intended use and
foreseeable misuse; eliminate risks as far as reasonably practicable through inherently safe design and
manufacture; reduce as far as reasonably practicable the remaining risks by taking adequate protection
measures, including alarms; and inform users of any residual risks.
12. Medical devices should achieve the performance intended by the manufacturer and be designed,
manufactured and packaged in such a way that, during normal conditions of use, they are suitable for their
intended purpose.
13. Medical devices should be designed, manufactured and packaged in such a way that their characteristics and
performances during their intended use will not be adversely affected by transport and storage conditions (for
example, fluctuations of temperature and humidity) taking account of the instructions and information provided
by the manufacturer.
14. Every medical device requires clinical evidence, appropriate for its intended use and classification of the
medical device, demonstrating that the device complies with the applicable provisions of the essential
principles.
Devices with a diagnostic or measuring function:
Diagnostic devices should be designed and manufactured in such a way as to provide sufficient accuracy,
precision and stability for their intended use, based on appropriate scientific and technical methods. In
particular the design should address sensitivity, specificity, trueness, repeatability, and reproducibility, control of
known relevant interference and limits of detection, as appropriate. Where the performance of devices depends on
the use of calibrators or control materials, the traceability of values assigned to such calibrators or control
materials should be assured through a quality management system. Any measurement, monitoring or display
scale should be designed in line with ergonomic principles, taking account of the intended purpose of the device.
Wherever possible values expressed numerically should be in commonly accepted, standardized units, and
understood by the users of the devices .
Import Regulations
Presently, the Indian market for medical devices is largely unregulated. Medical devices are freely imported into
India. The purchaser (whether it is a government hospital, a private hospital or a doctor) evaluates the quality of
the product being purchased. Normally, the FDA and Conformité Européene (CE) approved products are
preferred because of their better quality and performance. But, India being a price sensitive market, low-priced
medical devices finds a big market. To ensure the quality of healthcare service, the Government of India (GOI) is
in the process of developing regulations for medical devices. The authority regulating medical devices in India are
the CDSCO in the Ministry of Health. The regulatory procedure will be clear only after the government notifies the
regulations and the CDSCO provides the import guidelines. This paper presents the registration requirement and
the standard procedure to import medical devices into India. It provides an overview of the Indian Government’s
plan to regulate medical devices.
CONCLUSION
India is one of the largest market for the foreign companies as well as consumer for the medical devices and the
regulation for the guidelines must be implemented strictly to ensure the quality of the diagnosis and treatment and
the opportunities in the business for the medical devices.
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