基于良好审查规范(GRRP)国际协调性指南文件研究对我国医疗器械监管的启示  

Research and Reflection on the Coordinated Guidelines for Medical Devices Good Regulatory Review Practice Working Group of IMDRF

作　　者：杨宇希 Yang Yuxi(Center for Medical Device Evaluation of China National Medical Products Administration,Beijing 100081,China)

机构地区：[1]国家药品监督管理局医疗器械技术审评中心,北京100081

出　　处：《中国药事》2024年第8期876-881,共6页Chinese Pharmaceutical Affairs

摘　　要：目的:良好审查规范(GRRP)工作组历时7年,起草并发布协调性指南文件8项。本文旨在梳理和研究系列文件要义,探讨医疗器械国际监管协调的发展与优势。方法:梳理GRRP工作情况和指南文件主要内容,分析文件所汇集的国际经验和共识,展示系列文件在我国和成员监管区域的转化应用情况。结果与结论:国际医疗器械监管机构论坛(IMDRF)GRRP工作组从监管机构职责、合格评定机构作决策的结构和过程、产品安全有效等方面制定的协调性指南文件在我国完全实施,符合我国医疗器械创新监管发展的新需要,体现我国在国际监管协调方面的主动作为。Objective:The Good Regulatory Review Practice(GRRP)Working Group has been working for 7 years to draft and publish 8 coordination guideline documents.This article aims to summarize and study the essence of a series of documents,and explore the development and advantages of international regulatory coordination of medical devices.Methods:The work situation of GRRP and the main content of the guideline document are sorted out,and the international experience and consensus gathered in the document are analyzed,as well as the implementation of the series of documents in China and member regulatory regions are explored.Results and Conclusion:The coordinated guideline documents developed by the International Medical Device Regulators Forum(IMDRF)GRRP working group on regulatory responsibilities,the structure and process of decision-making by conformity assessment bodies,and product safety and effectiveness has been fully implemented in China,which meets the new needs of China's medical device innovation regulatory development and reflects China's proactive efforts in international regulatory coordination.

关 键 词：医疗器械合格评定机构 国际医疗器械监管机构论坛 良好审查规范 

分 类 号：R-1[医药卫生] R95