What does MoHFW's order for regulating all Class C & D medical devices under the Licensing regime have in store for you?

The Ministry of Health & Family Welfare, often abbreviated as MoHFW, has announced a notification vide S.O. 648 (E) dated 11^th February 2020 mentioning all medical devices as per sub-clause (iv) of clause (b) of section 3 of the Drugs & Cosmetics (D&C) Act, 1940, which is in effect from 1^st April 2020.

To regulate all medical devices, the Ministry has published G.S.R. 102 (E) dated 11^th February 2020 to regulate such devices phase-wise. According to the said notification, the Class C & D medical devices will be under a licensing regime from 1^st October 2023.

Meanwhile, this office has received representations from many Stakeholders and Associations requesting that the business continuity not be hindered because of the implementation of the licensing regime w.e.f 1^st October 2023 for Class C & D medical devices.

Considering the above, it has been decided that in case an existing manufacturer/importer who is already manufacturing/importing any of the aforementioned Class C & D Medical Devices has applied to the Central Licensing Authority for obtaining a manufacturing/import license in respect of the already mentioned device(s) under the norms of Medical Devices Rules, 2017, the said application must be deemed valid. Also, the manufacturer/importer shall resume manufacture/ import medical devices up to six months from the date of issue of this order or till the period the Central Licensing Authority has decided on the said application, whichever is earlier.