The Central Drugs Standard Control Organization vide circular dated 30th September, 2022 has clarified that in case, if an existing importer/manufacturer who is already importing /manufacturing any of Class A or Class B Medical Devices, has submitted application to Central Licensing Authority or State Licensing Authority on or before 30.09.2022, as the case may be, for grant of import /manufacturing license in respect of the said device(s) under the provisions of MDR, 2017, the said application shall be deemed valid.
The importer/manufacturer can continue to import /manufacture the said device(s) up to 6 months from the date of issue of this order or till the time, the Central Licensing Authority or State Licensing Authority, as the case may be, takes a decision on the application, whichever is earlier.
