新型冠状病毒肺炎疫情下我国医疗器械应急审批情况分析

Analysis of actual operation of China's medical device emergency approval under COVID-19 conditions

分析了新型冠状病毒肺炎疫情期间国家及各省市医疗器械应急审批相关政策及其与常规审批的异同,讨论了所需重点医疗器械应急审批的实践运行情况。提出了应从完善和细化应急审批程序、加强上市后监管、统筹规划审评审批能力建设、信息公开透明4个方面完善医疗器械应急审批,以提升未来应对重大突发公共卫生事件的医疗器械应急审批能力及水平。

The policies related to emergency approval of medical devices under COVID-19 conditions were analyzed in provinces and China,and were compared with those for conventional approval.The actual operation of the emergency approval was discussed for the required important medical devices.It was proposed that the emergency approval process of medical devices in China should be improved in four aspects,namely,improving and refining the emergency approval procedure,strengthening post-marketing supervision,planning the review and approval capacity and building information transparency,in order to improve the emergency approval of medical devices to deal with major public medical emergencies in the future.