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Industry specific-Medical Central Ministry of Health & Family Welfare Drugs and Cosmetics Act, 1940

Conditions for mentioning the registration number on Medical Devices for the manufacturer and importers

18-Jan-2022 | G.S.R. 19(E)

The Ministry of Health and Family Welfare has issued the Medical Devices (Amendment) Rules, 2022.

- Rule 19B & 19D of the Rules defines "Registration of central medical devices for the manufacturer and importers", under sub-rule 2(iii), the proviso has been inserted, which states that "the manufacturer and importers submits an application, on or before the 28th February, 2022, they shall obtain undertaking of ISO 13485 certificate, on or before the 31st May, 2022, in lieu of certificate of compliance with respect to ISO 13485 defined under such sub-rule and generate the provisional registration number, which will remain valid up to the 31st May, 2022 or the date on which ISO certificate is obtained, whichever is earlier, for all purpose.
Further, the explanation states, by the virtue of proviso, that "In case, ISO 13485 certificate not obtained before the 31st May, 2022, the provisional registration shall be cancelled for all purposes without any notice."

- Rule 19C & 19E (Mentioning the registration number on the medical devices), prior to the amendment, the Manufacturer and importer requires to mention the registration number on the label of the medical device.

Now, as per the substitution of words under the rule, states "mentioning of registration number or provisional registration number, is as per the desire of the manufacturer and importers, on the label of the medical device, for a period up to 31st May, 2022".
After 31st May 2022, mentioning the registration number will be mandatory for all registration holders.

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