NMPA adjusts production license for imported medical devices

On September 25, the national medical product administration issued an announcement to adjust the domestic production license of imported medical devices (class II and class III). If the main raw materials and production processes are not changed and the quality management system is consistent, some of the approved original application materials can be used for the registration for domestic production. The documentation of overview, research data, clinical evaluation data, product risk analysis data of medical device products, in vitro diagnostic reagent products, research data of main raw materials (when applicable), research data of main production process and reaction system (whenRead More →

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