6 Month Extension for CDSCO Class C & Class D Non-Notified Medical Device

The Ministry of Health & Family Welfare (MoHFW) issued a notification, on February 11, 2020, categorizing all medical devices under sub-clause (iv) of clause (b) of section 3 of the Drugs and Cosmetics Act, 1940, with effect from April 1, 2020. 

To ensure the regulation of medical devices, MoHFW introduced G.S.R. 102 (E) on February 11, 2020, outlining a phased approach to regulate these devices. According to this notification, Class C and D medical devices will come under a licensing regime starting from October 1, 2023. 

During this period, the Ministry has received representations from various associations and stakeholders who have expressed concerns about the potential disruption to business continuity resulting from the implementation of the licensing regime for Class C and D medical devices from October 1, 2023. 

In light of these concerns, it has been decided that, in cases where existing importers or manufacturers of Class C or Class D Medical Devices have submitted applications to the Central Licensing Authority for the grant of import or manufacturing licenses under the provisions of the Medical Devices Rules, 2017, these applications will be considered valid. Importers and manufacturers who have already filed the application to Central Licensing Authority on or before 30th September 2023, can continue to import or manufacture the mentioned devices for up to six months from the date of this order or until the Central Licensing Authority makes a decision on the applications, whichever comes first.