Regulation/Guidelines

MoHFW Releases New Notification For The Registration And Labelling Requirements Of Medical Devices

  • 8th December, 2021
MoHFW Releases New Notification For The Registration And Labelling Requirements Of Medical Devices

The Drugs and Cosmetics Act, 1940, and Rules regulate all medical devices’ safety, quality, and performance. MoHFW (Ministry of Health and Family Welfare’s) has issued notification vide G.S.R. 102 (E) dated 11.02.2021, regarding registration and labeling requirements for medical devices to be effective from 01.04.2020 which fall under the definition of medical device as per notice vide S.O. 648(E)  dated 11.02.2021

Drugs Technical Advisory Board

The draft notification is released after consulting the Drugs Technical Advisory Board. The new draft rules will be considered on or after the expiry period of seven days from the date the Gazette copies will be made public

Objections and Suggestions

  • The Central Government will review any objections and suggestions received within the specified period. The same will be directed to the Under Secretary (Drugs Regulation), Ministry of Health and Family Welfare, Government of India, Room No. 434, C Wing, Nirman Bhavan, New Delhi – 110011.
  • Any objections and suggestions can be emailed at drugsdiv-mohfw@gov.in.

Draft Rules

  • These rules may be called Medical Devices Amendment Rules, 2021.
  • The new rules will come into force on the date of the final publication of the Official Gazette.
  • According to the notification, medical devices will be subject to voluntary registration from April 2020 to September 2021.
RulesChanges to be made
Rule 19 BChanges are to be made in subrule(2), in item (iii) at the end. The following explanation is to be mentioned:— If an applicant submits on or before 30th November 2021, the applicant will receive ISO 13485 certificate on or before 31st May 2022 instead of the existing compliance present in clause (iii) of sub-rule (2) of rule 19B, a provisional registration number will be generated that will remain valid until 31st May 2022. The provisional number will be valid for all purposes.  
Rule 19CInstead of the words “shall mention the registration number”, the following words, letters and figures are to be replaced “may, if desired, mention the registration or provisional registration number, as the case may be, up to the 31st May 2022, after which it shall be mandatory”.
Rule 19DChanges are to be made in sub-rule(2), in item (iii), at the end, the following should be mentioned:— If an applicant submits on or before 30th November 2021, the applicant will receive ISO 13485 certificate on or before 31st May 2022 instead of the existing compliance present in clause (iii) of sub-rule (2) of rule 19D, a provisional registration number will be generated that will remain valid until 31st May 2022. The provisional number will be valid for all purposes.  
Rule 19EInstead of the words “shall mention the registration number”, the following words, letters and figures are to be replaced “may, if desired, mention the registration or provisional registration number, as the case may be, up to the 31st May 2022, after which it shall be mandatory”.
Table 1: New draft rules

Class A,B,C,D Medical Devices Registration

After October 2021, Class A and B medical devices registration will be subject to mandatory registration until September 2022, and Class C and D medical devices will be subject to compulsory registration until September 2023.

Stakeholders

Stakeholders have informed the Agency that there is still a long way to go in achieving complete preparedness by the industry in light of the disruption caused by COVID-19. A review of the representations is being conducted by the Ministry of Health and Family Welfare, Govt. of India.

For removal of doubt

If the ISO 13485 certificate is not obtained by the 31st May 2022, the applicant’s undertaking is as per the provision. In that case, the provisional registration will be deemed to have been canceled for all purposes without further notice.

Summary:

  • Drugs Controller General of India has issued notification dated 11.02.2021, specifying all the device falling under the definition of medical device to obtain registration number effective from 01.04.2021
  •  The new rules will further amend the Medical Device Rules, 2017.
  • The necessary changes have been made to the medical devices under sub-clause (iv) of clause (b) of section 3 of the Drugs and Cosmetics Act, 1940 (23 of 1940).

Reference:

  1. Registration and labeling requirements of Medical Devices under the provisions of Medical Devices Rules, 2017. Accessed on 22.10.2021.