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CDSCO

Submission of application to continue import/manufacture of class C & D medical devices


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Importer & Manufacturer   |   CDSCO
16 May, 2024
Enforcement Date: 16 May, 2024
Submission of application to continue import/manufacture of class C & D medical devices

MoHFW has released G.S.R for regulation of Medical Devices in phase wise manner. To avoid disruptions in business continuity importers/manufacturers of class C & D medical devices have to submit an application on or before 30.09.2023 to the Central Licensing Authority. Import/export of device(s) is valid until 3 months from the date of this notice or until a decision on submitted application.


The Ministry of Health & Family Welfare (MoHFW) published notification, S.O. 648 (E) dated 11.02.2020 specifying all medical devices under sub-clause (iv) of clause (b) of section 3 of the Drugs and Cosmetics Act, 1940, effective from 01.04.2020. MoHFW has published G.S.R 102 (E) dated 11.02.2020 for the regulation of class C & D medical devices that will be under licensing regime from 01.10.2023. To ensure business continuity of associations and stakeholders is not disrupted, importers/manufacturers of said medical device(s) have to submit an application to the Central Licensing Authority for the grant of import/manufacture license of said medical devices. The importer/manufacturer can continue the import/manufacture of the said device(s) up to 3 months to the date of issue of this order or until the Central Licensing Authority makes a decision on your submitted application.

Applicable For: Importer & Manufacturer
Reference Number: F. No. 29/Misc/03/2023-DC (344) Notification Link

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