医疗器械“注册人制度”“九宫格管理”模式的探索

      Exploration of “Speed Dial Management” Model for Medical Device “MAH Policy”

      • 摘要: 阐述了我国近年来医疗器械“注册人制度”陆续出台的相关政策,在政策变革面临新发展机遇时,医疗器械“注册人制度”“九宫格管理”模式及该模式中总结的“三方、三规、三流”核心要素,形成了一套标准化、可实施、可复制的注册人项目交互管理机制,对医械行业推广实施“注册人制度”具有较强的借鉴意义。

         

        Abstract: This article expounds relevant policies of domestic medical device "MAH Policy" in recent years. When facing new development opportunities at this time of policy innovation, "Speed Dial Management" model summarized through the practice of "MAH Policy", together with the core elements of "three parties, three regulations and three flows" extracted from it, form a standardized, implementable and reproducible management mechanism. The experience has strong reference significance for the promotion and implementation of "MAH Policy" among medical device industry.

         

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