Abstract: Abstract Purpose：The paper studies the management status and regulations of inspection for international medical device registration quality management system and provides references for the reform of China’s medical device registration review and approval system.Methods：By adopting the comparative research method and starting from the inspection process and legal status of the medical device registration quality management system, this paper compares the management experience of China, the United States, the European Union, Japan, Canada and other countries(regions) and the guidance requirements of the product listing license registration of The International Medical Device Regulators Forum (IMDRF) .Results and conclusions：The products that have obtained the medical device registration license shall be designed, manufactured and delivered to the market under the medical device registration quality management system. Medical device quality management system should be the content of medical device registration system evaluation; According to the product risk organization quality management system on-site inspection, general category II or above products need to organize on-site inspection, which can be completed before registration review or simultaneously.