Analysis on China and US Medical Device Emergency Approval Systems and
Their Practical Application
YAN Shu, CHEN Juan, OUYANG Zhaolian
Department of Strategic Intelligence Research on Medical Device and Drug, Institute of Medical Information, Chinese Academy of
Medical Sciences, Beijing 100020, China
Abstract：Objective To generalize the characteristics and advantages of the Chinese medical device emergency approval system and
American medical countermeasures emergency use authorization mechanism, and provide suggestions with the consideration of the
Chinese medical device administration system. Methods The legal basis, management, procedure, and the practices of responding
to medical device shortage during public health emergencies of the two systems were examined and compared. Results Both systems
played important roles in supporting emergency response and increasing the availability of medical devices urgently needed during
public health emergencies. However, because of the early release of Chinese emergency approval system documents with no more
amendment, the completion of contents and details was necessary. Conclusion Advices as expanding the scope and enhancing the
standardization of emergency approval system, scientifically optimizing the criteria of the review and appropriately moderating the
requirement of clinical data, along with strengthening the post-market supervision and providing adequate guidance of re-registration
are provided.
严舒，陈娟，欧阳昭连. 中美医疗器械应急审批制度与实践分析[J]. 中国医疗设备, 2021, 36(7): 120-124.
YAN Shu, CHEN Juan, OUYANG Zhaolian. Analysis on China and US Medical Device Emergency Approval Systems and
Their Practical Application. China Medical Devices, 2021, 36(7): 120-124.
