The Drugs Controller General (India) has notification for medical devices pertaining to registration and labelling.
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
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
Rules | Changes to be made |
Rule 19 B | Changes 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 19C | Instead 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 19D | Changes 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 19E | Instead 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”. |
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 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.
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.
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