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Post Approval Changes
For major changes the license holder must obtain prior approval and for any minor change as specified in Sixth Schedule of India MDR, a notification to State or Central licensing authority required.
Medical Device QMS
The manufacturing site must comply with the requirements of quality management system as specified under Fifth Schedule of India MDR, which is required to produce medical devices of same quality.
Indian Agent
An authorized agent should act as the official representative for obtaining import licence in India and submit all necessary documents, as defined in the Fourth Schedule, for the import licence of medical device.
India Medical Device Registration Services
Guidance issued by Government of India on 3rd Sep 2020 regarding Device Classification of Non Notified Devices.
