The Central Drugs Standard Control Organization (CDSCO) on October 12, 2023, issued a notification regarding the regulation of all Class C & D Medical Devices under Licensing regime w.e.f October 01, 2023.
The CDSCO has received representations from various Associations and Stakeholders, requesting that the business continuity should not be disrupted due to the implementation of a licensing regime for Class C & D medical devices w.e.f. October 01, 2023.
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 licence in respect of the said device(s) under the provisions of Medical Devices 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 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.
[Notification No. 29/Misc/03/2023-DC (344)]
