The Central Drugs Standard Control Organisation (CDSCO) has issued a circular clarifying that an existing manufacturer or importer of Class C or Class D medical devices can continue to import/ manufacture these devices till six months from the date of issue of this order. This circular was issued on 12th October, 2023.
Therefore, as per the circular, this extension is available on the fulfillment of the following conditions:
- The importer or manufacturer of class C or class D medical devices has already submitted an application for grant of import or manufacturing licence
- Such application was made to the Central Licensing Authority on or before 30th September, 2023
- The importer or manufacturer is already importing or manufacturing such devices
Hence, on the satisfaction of the above conditions, the circular permits importers and manufacturers to continue their operations until 12th April, 2024 or until their applications are decided, whichever is earlier.
It may be recalled that on 11th February, 2020, the Ministry of Health and Family Welfare had published the Medical Devices (Amendment) Rules, 2020. As per this notification, every medical device notified as a “Drug“ under section 3(b) of the Drugs and Cosmetics Act, 1940, (except the devices specified in the Annexure of Eighth Schedule of these rules) shall be registered with the Central Licensing Authority through an identified online portal established by the Central Drugs Standard Control Organization.
Now therefore, the CDSCO in view of implementing this licensing regime for Class C and Class D medical devices has issued the present circular to limit the disruption to business continuity.