The Ministry of Health & Family Welfare (MoHFW) had issued a notification on February 11, 2020, designating all medical devices under sub-clause (iv) of clause (b) of section 3 of the Drugs & Cosmetics Act, 1940, effective from April 1, 2020. To regulate these medical devices, MoHFW had published G.S.R. 102 (E), outlining a phased approach for their regulation. According to this notification, Class C and D medical devices were scheduled to enter the licensing regime starting October 1, 2023.

Hence, DCGI has notified, that if an existing importer or manufacturer, already engaged in importing or manufacturing any of the aforementioned Class C and D medical devices, submits an application to the Central Licensing Authority for an import/manufacturing license under the Medical Devices Rules, 2017, on or before September 30, 2023, the application will be deemed valid. The importer or manufacturer can continue their operations for up to three months from the date of this order or until the Central Licensing Authority makes a decision on the application, whichever occurs first. Click here to read more.