The Indian Ministry of Health issued a set of new guidelines on 17 October, 2016 called “The Medical Device Rules, 2016” to define and regulate medical devices as a separate category. This move is to develop an in-depth regulatory framework for medical devices. The new guidelines will make medical device regulations stringent for both manufacturing and importation of medical devices.
The Medical device draft of the CDSCO covers on all major aspects of Medical Device Regulation in India including device definitions and classifications, notified body roles, validity of licenses etc., This article describes about the new medical device forms and their purposes.
a. Information to be submitted with the application for grant of licence to manufacture or import of a Class A medical device,-
The manufacturer or authorized agent shall submit the duly signed and notarized (in case of import);
Summary of any reported Serious Adverse Event in any of the countries where device is marketed and action taken by the manufacturer and National Regulatory Authority concerned.
In case of import,
Plant registration or approval or renewed certificate issued by the competent authority of the country concerned.
Duly notarized copy of Certificate, issued by the competent authority of the country concerned, in respect of the manufacturer and manufacturing site’s Quality Management System, Full Quality Assurance or Production Quality Assurance.
Duly notarized copy of latest inspections or audit reports carried out by Notified bodies or National Regulatory Authority or Competent Authority within last 3 years, if any.
Summary technical document including,
Device description, specification including variants and accessories,
intended use of the device,
In case of in vitro medical devices, a summary of analytical technology, relevant analysis and test procedure,
material of construction (except in vitro diagnostic medical device),
Working principle and use of a Novel technology(if any),
Labels and Package inserts (IFU, etc..)
Analytical Performance Summary (only in case of in vitro diagnostic medical device)
Site or Plant Master File as specified in Appendix I of this Schedule.
Essential Principles checklist for demonstrating conformity to the Essential Principles of Safety and Performance of the Medical Device.
b. Information to be submitted with the application for grant of licence to manufacture or import of a Class B, Class C or Class D medical device,-
The manufacturer or authorized agent shall submit the duly signed and notarized (in case of import) information pertaining to Manufacturing premises in the following format.
General Information as specified in sub-clause (a) of clause (i) of Part II of this Schedule.
Site or plant Master File as specified in Appendix I of this Schedule.
Device master file as specified in Appendix II or Appendix III, as the case may be, of this Schedule.
Essential Principles checklist for demonstrating conformity to the Essential Principles of Safety and Performance of the Medical Device.
Forms and their Purposes:
| Name of the Forms | Purpose of the Forms |
| MD1 | Application for grant of Certificate of Registration of a Notified Body |
| MD2 | Certificate of Registration for a Notified Body under the Medical Devices Rules, 2016 |
| MD3 | Application for Grant of Licence to Manufacture for Sale and Distribution of Class A or Class B medical device |
| MD4 | Application for Grant of Licence to Manufacture for Sale or for Distribution of (i) Class C or Class D or (ii) Class A or Class B, and Class C or Class D Medical Devices. |
| MD5 | Application for Grant of Loan Licence to Manufacture for Sale or for Distribution of Class A or Class B medical device |
| MD6 | Application for Grant of Loan Licence to Manufacture for Sale and Distribution of (i) Class C or Class D or (ii) Class A or Class B, and Class C or Class D Medical Devices. |
| MD7 | Licence to Manufacture for Sale and Distribution of (i) Class C or Class D or (ii) Class A or Class B, and Class C or Class D Medical Devices. |
| MD8 | Loan Licence to Manufacture for Sale and Distribution of Class A or Class B or Class C or Class D medical device |
| MD9 | Form in which the Audit or Inspection Book shall be maintained. |
| MD10 | Application for licence to manufacture medical device for purpose of clinical investigations, test, evaluation, examination, demonstration or training |
| MD11 | Licence to Manufacture Medical Devices for the Purposes of Clinical Investigations or Test or Evaluation or Demonstration or Training |
| MD12 | Application for issue of import licence to import medical device |
| MD13 | Licence to Import Medical Device |
| MD14 | Application for Licence to Import Medical Devices for the Purposes of Clinical Investigations or Test or Evaluation or Demonstration or Training |
| MD15 | Licence to Import Medical Devices for the Purposes of Clinical Investigations or Test or Evaluation or Demonstration or Training |
| MD16 | Application for Licence to Import Medical Devices for the Purposes by a Government Hospital or Statutory Medical Institution for the treatment of patients |
| MD17 | Licence to Import Medical Device by a Government Hospital or Statutory Medical Institution for the treatment of patients |
| MD18 | Application for Licence to Import Small Quantity of Medical Devices for Personal Use |
| MD19 | Permission to Import of Small Quantities of Medical Devices for Personal Use |
| MD20 | Application for Grant of permission to conduct Clinical Investigation |
| MD21 | Grant of permission to conduct Clinical Investigation |
| MD22 | Application for Grant of permission to conduct Clinical Performance Evaluation |
| MD23 | Grant of permission to conduct clinical performance evaluation |
| MD24 | Application for grant of permission to import or manufacture medical device does not have predicate medical device |
| MD25 | Permission to import or manufacture medical device does not have predicate medical device |
| MD26 | Application for grant of permission to Import or Manufacture of New In Vitro Diagnostic Medical Device |
| MD27 | Permission to Import or Manufacturer New In Vitro Diagnostic Medical Device |
| MD28 | Report of Test or Evaluation of Medical Devices by Medical Device Testing Officer |
| MD29 | Application from a purchaser for test or evaluation of a Medical Device under section 26 of the Drugs and Cosmetics Act, 1940 |
| MD30 | Order Under Section 22(1)(c) of the Drugs and Cosmetics Act, I940 requiring a person not to dispose of stock in his possession |
| MD31 | Receipt for stock of medical devices for record, register, document or material object seized under Section 22(1) (c) or (cc) of the Drugs and Cosmetics Act, 1940 |
| MD32 | Intimation of Person from Whom Sample is taken |
| MD33 | Receipt for Sample of medical device(s) taken where fair price tendered thereof under sub-section (1) of Section 23 of the Drugs and Cosmetics Act, 1940 is refused |
| MD34 | Memorandum to Medical Device Testing Officer |
The health ministry’s newly released draft rules aim to bring India’s regulatory requirements in compliance with International environment. The rules would be in place till the government comes out with a separate legislation to regulate the Rs 30,000-crore medical device sector, which is growing steadily.