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CDSCO

License Applications for Class C and D Medical Devices deemed valid for upto 6 months


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Importer & Manufacturer   |   CDSCO
12 October, 2023
Enforcement Date: 12 October, 2023
License Applications for Class C and D Medical Devices deemed valid for upto 6 months

As per the notification dated 12th October 2023, CDSCO stated that all applications submitted by the manufacturer or importer of Class C and D medical devices would be considered valid for upto 6 months with effect from 1st October 2023. This prevents any disruption in business continuity due to the implementation of the licensing regime.


CDSCO published a notification vide G.S.R. 102 (E) dated 11th February 2020, for Class C and D medical devices to be brought under the licensing regime from 1st October 2023. On 12th October 2023, CDSCO declared that the applications submitted by the manufacturer or importer of Class C & D medical devices are deemed valid for upto 6 months. This ensures that this business continuity shall not be disrupted by the implementation of licensing authority. Therefore, if an importer/manufacturer is already importing/manufacturing any of Class C and D medical devices and has already submitted the application to the Central Licensing Authority under the provisions of the Medical Devices Rules 2017, the application would be valid and the importer/manufacturer can continue to manufacture/import these medical devices upto six months from the date of issue of the order or until the licensing authority decides on the application.

Applicable For: Importer & Manufacturer
Reference Number: 29/Misc/03/2023-DC(344) Notification Link

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