Analysis on the registration and review system of emergency medical devices in China and abroad in the context of COVID-19

Abstract

Objective
 In the context of COVID-19, the domestic and foreign demand for emergency medical devices, such as medical masks and protective suits, is surging, and it is urgent to complete the registration and review of emergency medical devices with high efficiency and quality, which requires a mature and perfect registration and review system as the support. This paper aims to compare and analyze the domestic and foreign registration and review system of emergency medical device, summarize the good experience, and provide feasible suggestions for improving China's emergency medical device registration and review system.
 Method
 USA, Canada, Japan and the European Union were selected to make a comparative analysis with China from the aspects of legal system and emergency registration and review procedure by literature research, comparative analysis and other theoretical methods.
 Results
 The legal system and review mechanism of emergency medical device registration in China have been relatively perfect, but the safety and risk balance mechanism and the comprehensiveness of emergency management measures need to be further improved.
 Conclusion
 On the basis of maintaining its own institutional advantages, China should learn from foreign experience to further optimize the registration and review system of emergency medical devices, so as to improve the ability of response and implementation of China in public health emergencies.