中美欧医美注射类医疗器械监管情况及思考

      Regulatory Requirements and Considerations of Medical Aesthetic Injection Medical Devices in China, USA and European Union

      • 摘要: 该文总结了医美注射类医疗器械在中国、美国和欧盟上市情况以及法规监管情况,对比分析了我国与美国、欧盟法规的监管异同。中美欧在医美注射类医疗器械的监管方面有所不同,但实质上趋同。建议我国医疗器械监管部门完善相关指导原则的制定、加大对该类产品的标识管理以及上市后产品的监管力度,建立产品全生命周期的电子信息化监管系统,提升我国对医美注射类医疗器械的监管水平和能力,促进医美行业健康发展。

         

        Abstract: This study summarizes the marketing access and regulatory requirements of medical aesthetic injection medical devices in China, the USA, and the European Union (EU), and conducts a comparative analysis of the regulatory similarities and differences among these regions. There are differences in supervision of medical aesthetic injection medical devices in China, USA, and EU, but they are essentially converging. It is recommended that Chinese medical device authorities improve the guidelines requirements, strengthen the labeling management and post-market surveillance of products, establish an electronic information management system for the total product life cycle, enhance the review level and capability of medical aesthetic injection medical devices in China, and promote the healthy development of the aesthetic industry.

         

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