Part 2 NMPA Medical Device QMS/GMP And Its Alignment With International Regulations Or Standards.


This session of the webinar introduces the medical device QMS/GMP and its alignment with international regulations or standards. The history of the medical device regulation in China, an overview of the newly released Decree No. 739. The speaker also introduced the product lifecycle supervision from the perspective of risk management, marketing authorization holder, and unique device identification. It was also mentioned in this video the history of medical device quality management system in China and a comparison of GMP in typical countries including China, US, EU, Canada, and Japan. It also compares the China GMP vs. ISO13485 vs. qSR 820. The speaker also introduced the quality management during the product design control, design history file, the use of DHF in product life cycle management, and the use of DHF to support China NMPA registration.