浅谈中美医疗器械监管创新

Discussion on Administrative Innovation of Medical Device in China and U.S

摘要: 该文首先梳理我国现有的医疗器械创新审评审批路径，同时介绍了美国针对创新型医疗器械的优先审评途径、快速通道路径、人道主义豁免和定制器械审批路径，并详细介绍了用以支持科学审评的创新工具和方法，为完善我国医疗器械监管创新提供参考。

Abstract: This article refreshes the innovative review approach of medical device in China at first. It proposes reference through presenting a series of existing review and approval of innovative medical device in U.S. as well as new tools and methods for supporting scientific review.