RAAJ GPRAC PRIVATE LIMITED

Registration on the BIS portal

[LSSSDC Accredited, ISO-29993-2017 Certified ]

Presented By: RAJASHRI OJHA & SNEHA PANDIT
Designation: Regulatory Affairs Consultant
RAAJ GPRAC PRIVATE LTD.
rajashrio@gmail.com, raajgprac@gmail.com
www.raajpharmaelearning.com
©Raaj GPRAC, All rights reserved
 Disclaimer

Contents of this presentation are the presenters personal views and do not
necessarily represent any companies policies and position

Some images are taken – freely available from the internet for a
diagrammatic representation of the content and the source is
acknowledged

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 Medical Devices Rules, 2017
• Medical Device rules are effective from 01.01.2018,
under the Drugs and Cosmetics Act 1940 -
• To regulate the Clinical Investigation, Manufacture,
Import, Sale and Distribution of the medical devices in
the country.
• The Medical Devices Rules, 2017 are harmonised with
the international regulatory practices and provide
comprehensive legislation for the regulation of Medical
Devices, which will foster Make in India also.

©Raaj GPRAC, All rights reserved

 Scope of the regulation
Medical Device Rules,2017 shall be applicable to:
(i)Substances used for in vitro diagnosis and surgical dressings, surgical bandages,
surgical staples, surgical sutures, ligatures, blood and blood component
collection bag with or without anticoagulant covered under sub-clause (i) of
section 3 of the Drugs and Cosmetics Act, 1940 (23 of 1940);
(ii)Substances including mechanical contraceptives (condoms, intrauterine
devices, tubal rings), disinfectants and insecticides notified under sub-clause (ii)
of section 3 of the Drugs and Cosmetics Act, 1940 (23 of 1940); and
(iii) Devices notified from time to time under sub-clause (iv), of clause (b) of
section 3 of the Drugs and Cosmetics Act, 1940 (23 of 1940);
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 Rule no 7 of - MDR, 2017

7. Product standards for medical device.—

(1) The medical device shall conform to the standards laid down by the
Bureau of Indian Standards established under section 3 of the Bureau
of Indian Standards Act, 1985 (63 of 1985) or as may be notified by the
Ministry of Health and Family Welfare in the Central Government, from
time to time.
(2) Where no relevant Standard of any medical device has been laid down
under sub-rule (1), such device shall conform to the standard laid down
by the International Organisation for Standardisation (ISO) or the
International Electro Technical Commission (IEC), or by any other
pharmacopoeial standards. (3) In case of the standards which have not
been specified under sub-rule (1) and sub-rule (2), the device shall
conform to the validated manufacturer’s standards.
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 BIS
BIS is the National Standard Body of India established under the BIS
Act 2016 for the harmonious development of the activities of
standardization, marking and quality certification of goods and for
matters connected therewith or incidental there to.
BIS has been providing traceability and tangibility benefits to the
national economy in a number of ways – providing safe reliable quality
goods; minimizing health hazards to consumers; promoting exports
and imports substitute; control over proliferation of varieties etc.
through standardization, certification and testing

https://bis.gov.in/

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BIS

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 Scope of BIS
• Standards Formulation
• Product Certification Scheme
• System Certification scheme
• Compulsory Registration Scheme
• Foreign Manufacturers Certification Scheme
• Hall Marking Scheme
• Laboratory Services
• Laboratory Recognition Scheme
• Sale of Indian Standards
• Consumer Affairs Activities
• Promotional Activities
• Training Services, National & International level
• Information Services
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 Types of schemes under BIS
The certification scheme operates through a network of 32 Branch Offices set up in State capitals or
major industrial towns and 5 Regional Offices overseeing the work of the Branch offices. Although, the
scheme itself is voluntary in nature, the Government of India, on considerations of public health and
safety, security, infrastructure requirements and mass consumption has enforced compulsory
certification on various products through Orders issued from time to time under various Acts.
To view the products under Mandatory certification for ISI mark
https://bis.gov.in/index.php/product-certification/products-under-compulsory-
certification/scheme-i-mark-scheme/

To view the products under Mandatory certification for registration with BIS
https://bis.gov.in/index.php/product-certification/products-under-compulsory-
certification/scheme-ii-registration-scheme/

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 Types of Schemes under BIS
• Normal Procedure (Domestic Manufacturers)
In the normal process, you will have to submit a BIS certification application
along with necessary documents and fees. After the submission of application, a
BIS officer will conduct a verification of your factory premises. Samples of your
products will be taken and will be tested both in the factory & independently. If
the sample is approved, you will get BIS certification. This process can take 4
months to complete.
• Simplified Procedure (Domestic Manufacturers)
If you are registering under the simplified procedure, you will have to submit a
test report of product samples from a BIS-approved laboratory along with
required documents. A BIS officer will conduct verification of your factory
premises if your test reports are satisfactory. The certification is granted within
30 days if verification of factory premises is also satisfactory.

©Raaj GPRAC, All rights reserved

 Types of Schemes under BIS
• Tatkal Scheme
If you are manufacturing those products which require mandatory BIS certification
as per Government notification, you can obtain it under the Tatkal scheme. Tatkal
applications are processed on a priority basis. You will obtain BIS certification within
a defined timeline of 30 days.
• ECO Mark Scheme
Are you manufacturing eco-friendly products? You can obtain BIS license under a
separate BIS certification scheme. All eco-friendly products must fulfil additional
requirements specified under Indian Standards to get an Eco Mark. The process to
obtain an Eco Mark is similar to the Domestic Manufacturer Scheme.
• Foreign Manufacturers Certification Scheme
If you are a foreign manufacturer or an overseas applicant, you can obtain the
license to use the ISI mark under a uniquely designed certification scheme within six
months.

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 BIS Process
• The BIS Act 2016, Rules and Regulations framed there under authorizes
BIS to undertake conformity assessment of products, services, systems
and processes. Under the product certification scheme – I, BIS grants
license to use the standard mark or grants certificate of conformity as
per conformity assessment schemes given in BIS (Conformity
Assessment) Regulations, 2018 . The conformity assessment schemes
are laid down in BIS (Conformity Assessment) Regulations, 2018 which
are based on principles laid down in IS/ISO/IEC 17067: 2013.

• https://bis.gov.in/PDF/bs/BIS_Conformity_Assessment_Regulation_20
18_Gazette_Notification.pdf

©Raaj GPRAC, All rights reserved

 BIS Process
• The BIS Act 2016, Rules and Regulations framed there under authorizes
BIS to undertake conformity assessment of products, services, systems
and processes. Under the product certification scheme – I, BIS grants
license to use the standard mark or grants certificate of conformity as
per conformity assessment schemes given in BIS (Conformity
Assessment) Regulations, 2018 . The conformity assessment schemes
are laid down in BIS (Conformity Assessment) Regulations, 2018 which
are based on principles laid down in IS/ISO/IEC 17067: 2013.

• https://bis.gov.in/PDF/bs/BIS_Conformity_Assessment_Regulation_20
18_Gazette_Notification.pdf

©Raaj GPRAC, All rights reserved

 Indian Standards
• To get an ISI mark from BIS for your products under voluntary certification scheme,
there needs to be a published Indian Standard.

• To view all the published standards

https://www.services.bis.gov.in:8071/php/BIS_2.0/dgdashboard/Published_Standards

• Most of the Indian standards are available free and those which are not are available
at nominal costs. To download the standards
https://standardsbis.bsbedge.com/
Create a free account on the above website and search for required standard. You can
purchase it or if it available for free you can download pdf file.

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 BIS Approved labs
• The manufacturers who have to apply for ISI mark, need to get their product tested
in a BIS recognised lab
https://bis.gov.in/PDF/bs/NewLab_list1.pdf

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©Raaj GPRAC, All rights reserved
 BIS Approved labs
To check which in which BIS approved lab your product can be tested, you can check
w.r.t to the Indian Standard corresponding to your product.

http://164.100.105.198:8096/bis_access/iswise_v2.html

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 BIS Guidelines
BIS has created a document which gives an overview about the process
It includes
1. General Principles for GoL (Grant of license)
2. Application
3. Options for GoL
4. Laboratory
5. Conformity of Raw Material
6. Undertaking
7. Factory visit
8. Factory Testing
9. Testing of Sample
10. Processing for GoL

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 BIS Guidelines
Grant of license document – This document covers only the basics of the process

*Note: This document will be given along with this presentation

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 BIS Process
To apply for a BIS license, you have to visit ‘Manak Online’
https://www.manakonline.in/MANAK/login

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Create Login for Manak online

Click on New user for new registration

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Make sure, you read the registration guideline before you register
https://www.crsbis.in/BIS/app_srv/tdc/gl/format/Steps_for_Registration_on_BIS.pdf
You will need the following details to complete registration
1. Valid email address
2. Person of contact ; Name and Designation
3. Contact Details of Manufacturing Unit
4. Contact Details of Manufacturing Unit
5. Address of the Manufacturing Unit
6. Address for Correspondence
7. Address Authentication of Manufacturing Unit (For proof of name and address of manufacturing
unit, kindly upload a valid government issued document in which name and address of the
manufacturing unit to be clearly reflected along with reflection of manufacturing activity for
products related to Registration Scheme.)
8. On submission of the form, a verification email will be sent on the requested email ID. Kindly verify
your email.
9. On confirmation of email, BIS will verify the submitted documents. On positive verification, login
credentials will be given to the manufacturer.
Once, the Company documents are verified use the credentials to log in and you will get the
following screen
Then click on Product Certification.
When you click on Product Certification
You will get this Dashboard
 First you will have to enter your Organisation details

*Note: We will give you a sample application form for reference.

First you will have to enter your Organisation details
First you will have to enter your Factory details
When all the details have been submitted, you will come back to the dashboard and then click on
‘Apply for New license’
Then enter top management, Technical personnel Details
You will have to select the Indian standard against which you wish to test your product
1. Indian Standard – Enter the Indian standard against which you want to test your product

Make sure you enter the correct standard number, because once entered you cannot change it.

2. Then you will have to enter Grade/Type/Variety/Size/Class/Rating

Then once, Indian Standard is selected the Marking Fee will be calculated
This fee is for IS 9473 – N95 masks
This fee is for IS 17423 – Coveralls
Once, the marking fee is accepted
You will move to STI – Scheme of testing and Inspection

Download the file, it will include entire scope of testing.

The product will be tested for which parameters and which parameters will be checked during
inspection.
*Note: We will give you a sample STI document for reference.
Then Selection of Procedure

1. Normal
In the normal process, you will have to submit a BIS certification application along with necessary
documents and fees. After the submission of application, a BIS officer will conduct a verification of
your factory premises. Samples of your products will be taken and will be tested both in the factory
& independently. If the sample is approved, you will get BIS certification. This process can take 4
months to complete
2. Simplified
If you are registering under the simplified procedure, you will have to submit a test report of product
samples from a BIS-approved laboratory along with required documents. A BIS officer will conduct
verification of your factory premises if your test reports are satisfactory. The certification is granted
within 30 days if verification of factory premises is also satisfactory
Brand details
Enter the details of the Brand Name, and you have to inform BIS if there are any changes in the brand
name.
Manufacturing Machinery
Manufacturing Machinery
The excel format of the machinery document to be uploaded. Fill up these details and upload on this portal

Outsourced Process
Testing Equipment
Testing Equipment
The excel format of the testing equipment document to be uploaded. Fill up these details and upload on
this portal

If Testing equipment not available In-house

Production Information
Undertakings

Once, these are accepted. Then click on Next

In the next window, You will have to upload the following documents

• Document establishing legal identity of the firm*

• Process flow chart covering all process of manufacturing (From Raw material to Finished goods),
including details of in-process controls at each stage.
• Quality assurance systems followed (Quality manual, Quality plan, test formats)
• Drawing of product
• Location of the plant (from nearest airport/ guidance on how to reach)*
• Layout of the factory*
• Copies of certificates of qualification of quality control personnel
• Copies of calibration certificates of testing equipment
• Documents authenticating the firms premises*
• Hygiene condition document
In the next window, You will have to upload the following documents

• Document establishing legal identity of the firm*

• Process flow chart covering all process of manufacturing (From Raw material to Finished goods),
including details of in-process controls at each stage.
• Where Applicable, ‘Consent Letter’ from BIS recognized laboratory (for requirements which have to be
and / or are proposed to be got tested from outside Lab for which the applicant does not have In-House
Test Facilities).
• Quality assurance systems followed (Quality manual, Quality plan, test formats)
• Drawing of product
• Location of the plant (from nearest airport/ guidance on how to reach)*
• Layout of the factory*
In the next window, You will have to upload the following documents

• Copies of certificates of qualification of quality control personnel

• Copies of Test Certificates of Raw Material
• Undertaking that the license granted shall be put to under stop marking if the Verification Sample(s)
Drawn During Verification Visit of the BIS officer prior to the Grant Of License fail to conform to the
Indian Standard
• Copies of calibration certificates of testing equipment
• Documents authenticating the firms premises*
• Hygiene condition document

*Note: All undertakings will be printed on company letterhead and should be signed and stamped.

Once all the documents are uploaded you will move to the payment option
BIS will then review all the uploaded documents and then raise deficiencies or queries.
You will have 15 days to respond to the quires or your application could be rejected.

You will get notification on registered email address about queries.

To view queries, Login – Go to view application
To view application details or queries
Document if accepted, then there is a tick otherwise query is raised
Completion of application

1. All queries are satisfactorily responded to.

2. Payment is completed

Once, these 2 steps are completed then an Inspection date will be given by BIS.

And based on the procedure you have selected, BIS will complete its inspection and grant
of license.
Points which will be checked during factory visit
Factory Visit –
i)a self-evaluation cum verification report in the proforma, as given in Annexure-II
ii) Details of Quality Control Personnel
iii) Calibration Certificates of Testing Equipment to be verified during the visit
iv) Copies of Test Certificates of Raw Material, as applicable
v) Drawing of sample(s) of the Product and / or Components, as applicable
vi) Report of Hygienic Condition, if applicable
vii) Plant layout indicating the location of manufacturing area, storage area for raw material and
finished product, testing laboratory etc.
viii) Location Plan of the factory
ix) For the tests which are permitted to be subcontracted and not available with the manufacturer,
copy of the agreement or consent letter from the outside laboratory for which arrangement for sub-
contracting is made
x) Inspection and Test Plan proposed to be followed, if different from Scheme of Inspection andTesting
of the Bureau
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Check points during factory inspection

If your testing equipment is in-house

• Make sure each equipment is calibrated from a NABL accredited laboratory.
• Make sure installation reports and validation reports of each equipment are available.
• Make sure each equipment’s invoices are available
• File including all the documents uploaded to the BIS portal
• Each test mentioned in the Indian standard or STI will have to be performed in front of the BIS
inspector
• Make sure, you have performed each test before hand and stipulated the time needed for each
test. So ‘Man Days’ for the inspector can be calculated.
• Format of the factory test report is given in the next slide
Check points during factory inspection
Check points during factory inspection

If your testing equipment is NOT in-house

• File including all the documents uploaded to the BIS portal

• Raw material list
• Invoices of raw material
• Test reports of raw material
• The manufacturing process flowchart
• The manufacturing machinery list
• Process for packaging
After the factory inspection, if your company has zero
non conformities and the product complies
completely with the Indian Standard.

Then BIS will grant the license.

 Rajashri Survase-Ojha
9819125208
rajashrio@gmail.com
www.raajpharmaelearning.com