Govt. Grants License Relaxation of 6 Months for Class-A and Class-B Medical Devices

Gazette Notification G.S.R 102E issued by Ministry of Health and Family Welfare (MoHFW) on 11 Feb 2020 had made the compulsory licensing regime effective from 01 Oct 2022 for all non-regulated Class A and B medical devices. One day before this deadline (i.e. 30 Sep 2022), Central Drugs Standard Control Organization (CDSCO) issued Circular File No. 29/Misc/03/2022-DC(257) whereby 6 months relaxation is granted to all the importers/ manufacturers of Class A and Class B medical devices, to continue with import/manufacturing subject to the certain conditions. It’s a significant decision taken by Government to ensure that business continuity is not disrupted for the said devices due to implementation of licensing regime with effect from 01 Oct 2022.

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The circular states that:

“if an existing importer/manufacturer who is already importing /manufacturing any of Class A or Class B Medical Devices, has submitted application to Central Licensing Authority or State Licensing Authority on or before 30.09.2022, as the case may be, for grant of import /manufacturing licence in respect of the said device(s) under the provisions of MDR, 2017, the said application shall be deemed valid and the importer/manufacturer can continue to import /manufacture the said device(s) up to 6 months from the date of issue of this order or till the time, the Central Licensing Authority or State Licensing Authority, as the case may be, takes a decision on the said application, whichever is earlier.”

In our opinion, the above stated relaxation is applicable to importers/manufacturer of non-regulated Class A and B medical devices if they comply with below stated conditions and they can continue to import/manufacture such devices up to 6 months (i.e. 31 March 2023) or when a decision is taken on application, whichever is earlier:

• Registration of said devices is completed under Voluntary/Mandatory registration regime and already being imported/manufactured in India.

• Import/manufacturing license application of said devices have been submitted to respective licensing authority on or before 30 Sep 2022.

However, new product launches, to be imported/manufactured for the first time, are not covered under this relaxation even if Import/manufacturing license application is submitted on or before 30 Sep 2022 since new products will not comply with condition of already being imported/manufactured. To the best of our understanding, we believe that the main purpose of Circular is to ensure business continuity of existing products in India.

Feel free to reach out to us at info@innoreg.in for any assistance required with registration process of the said devices or other regulatory needs regarding medical devices registration in India.

References:

1. Relaxation Notice 29/Misc/03/2022-DC (257) dated 30 Sep 2020 - Click here (last accessed on 04 Oct 2022)

2. GSR 102(E) dated 11 Feb 2020 - Click here (last accessed on 04 Oct 2022)

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