CDSCO streamlines the process of application for product approved as medical device

Nov 27, 2019 | by Avantis RegTech Legal Research Team

Industry Specific Compliance

The Central Drugs Standard Control Organization (CDSCO) on November 15, 2019, issues an Office Memorandum to streamline the process of an application for product approved as medical device in the country of origin and not covered under the medical devices notified in the country. CDSCO have decided that processing of such applications will be done by New Drugs division or Import division of CDSCO and the applications should be submitted through SUGAM Portal. However the CMC, safety and efficacy data etc of the product should be submitted as per the checklist applicable for medical devices.


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