Abstract: Objective To analyze the current status as well as the opportunities and challenges facing post-marketing surveillance and evaluation of medical devices in my country, this paper puts forward the thinking of constructing vigilance system of Chinese medical device in the new era. Methods Based on China's national conditions, combined with the development status of my country's medical device industry and the reform of medical device supervision concepts brought about by deepening the review and approval system, this article analyzes the opportunities and challenges facing post-marketing surveillance and evaluation of medical devices in China by reviewing literature, data comparison and other method. Results Combined with the current situation of domestic and foreign regulatory regulations, ideas are offered as to how to improve the regulatory system of surveillance and evaluation quickly, enhance the capabilities of risk control of post-marketing medical device products, and construct vigilance system of Chinese medical device. Conclusion Exploring and promoting the construction of medical device vigilance system is an important subject of medical device supervision in the new era, new situation and new system under the guidance of regulatory science.

Key words: post-marketing surveillance and evaluation of medical device, adverse event, medical device vigilance