新冠疫情中对《医疗器械应急审批程序》的思考

The Reflection of Emergency Approval Procedures in the COVID-19 Outbreak

目的:综合评价目前我国《医疗器械应急审批程序》的应用,提出改进建议。方法:介绍我国《医疗器械应急审批程序》,并以2019新型冠状病毒检测试剂盒为例,重点分析我国《医疗器械应急审批程序》在应对突发公共卫生事件尤其是本次新型冠状病毒肺炎疫情中发挥的作用,为其进一步完善以及生产企业进行应急申报工作提出建议。结果与结论:《医疗器械应急审批程序》保障了临床急需检测试剂的高效审批,满足疫情控制需要,在本次疫情防控中发挥了重要作用。经过综合分析,从医疗器械监管、生产企业研发及生产、各方信息互通等方面提出探索性建议。

Objective:To evaluate Medical Device Emergency Approval Procedures in China,and make proposals for improvement.Methods:By introducing Medical Device Emergency Approval Procedures in China,we emphasize its role on Chinese public health emergency with an example of IVD in the COVID-19 outbreak,and put forward suggestions for the optimization of the Emergency Review Procedures and emergency declaration of manufacturers.Results and Conclusion:The Emergency Approval Procedures have been proved effective when ensuring the supplement of IVD products which were urgently needed for diagnosis,and greatly contributed to the prevention and control of the epidemic.Based on comprehensive analysis,exploratory suggestions were provided from the aspects of supervision of medical devices,R&D of manufacturers,and information exchange among all stakeholders.