The Central Drugs Standard Control Organisation (CDSCO) on May 16, 2024, issued regulation of all Class C & D Medical Devices under the Licensing regime w.e.f October 01, 2023.
The representations from various Associations and Stakeholders have been received by this office, requesting that the business continuity should not be disrupted due to the implementation of the licensing regime w.e.f. October 01, 2023, for Class C & D medical devices.
It has been decided that, in case, an existing importer or manufacturer who is already importing or manufacturing any of the above said Class C or Class D Medical Devices, has submitted an application on or before September 30, 2023, 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 or manufacture the said device up to three 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)]
