Guidelines of new medical devices regulation

The newly revised regulations on the supervision and administration of medical devices shall come into effect on June 1st, 2021. the National Medical Product Administration-NMPA is organizing the revision of supporting rules, normative documents and technical guidelines, etc., and issued the implementation guidelines on May 31. From 1 June 2021: Any enterprise or medical device development institution holding a medical device registration or filing for the first type of medical devices shall respectively fulfill the obligations of the registrant and the recorder of medical devices, strengthen the quality management of the whole life cycle of medical devices, and ensure theRead More →

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