CDSCO Regulatory Update
The Ministry of Health and Family Welfare (MoHFW) has issued a notification, S.O. 648 (E) dated 11.02.2020, listing all medical devices falling under sub-clause (iv) of clause (b) of section 3 of the Drugs and Cosmetics Act, 1940, effective from 01.04.2020.
To regulate these medical devices, MoHFW has released G.S.R. 102 (E) dated 11.02.2020, outlining regulations for their phased implementation. According to this notification, Class C & D medical devices will come under a licensing regime from 01.10.2023.
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Following this, various associations and stakeholders have expressed concerns regarding the potential disruption to business continuity due to the licensing regime implementation starting from 01.10.2023 for Class C & D medical devices.
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Considering these representations, it has been decided that if an existing importer or manufacturer, who is already involved in importing or manufacturing any Class C or Class D Medical Devices, submits an application to the Central Licensing Authority for an import or manufacturing license by 30.09.2023 under the provisions of the Medical Devices Rules, 2017, the application will be deemed valid. Consequently, the importer or manufacturer can continue importing or manufacturing the said devices for up to three months from the date of this order issuance or until the Central Licensing Authority makes a decision on the application, whichever comes first.
