Provides Manufacturers with an Additional 6 Months to Complete Application Process

On October 12, 2023, the Central Drugs Standard Control Organisation (CDSCO) issued Circular File No. 29/Misc/03/2023-DC (344) (link), granting a grace period for Import Licenses to qualifying Non-Regulatory Class C and D medical devices. This announcement came nearly two weeks after the October 1st deadline mentioned in G.S.R. 102 (E), which mandates Import Licenses for all Class C and D medical devices imported into India.

This grace period allows Non-Regulatory Class C and D medical devices that were registered and had pending Import License applications as of September 30, 2023, to continue their importation and marketing activities for an additional 6 months while awaiting application review. This process mirrors the one implemented for Class A and B devices last year.

Per the new Circular:

In view of the above, it has been decided that, in case, if an existing importer/manufacturer who is already importing /manufacturing any of the above said Class C or Class D Medical Devices, has submitted application to Central Licensing Authority, for grant of import/manufacturing licensce in respect of the said device(s) under the provisions of Medical Device Rules, 2017, the said application shall be deemed valid and the importer/manufacturer can continue to import /manufacture the said device(s) up to six (6) months from the date of issue of this order or till the time, the Central Licensing Authority, takes a decision on the said application, whichever is earlier.

As stated in G.S.R. 102 (E), released on February 11, 2020, all Class C and D medical devices were to be under the licensing regime beginning October 1, 2023. However, this grace period provides manufacturers with additional time to obtain their Import License(s) and ensures there is no interruption to the medical device supply in India.

For more information on registering your medical device in India, please see our dedicated page on the topic here.