IMDRF组织《医疗器械安全和性能的基本原则》内容简介及思考  

IMDRF Essential Principles of Safety and Performance of Medical Devices and IVD Medical Devices Introduction and Consideration

作　　者：孙嘉怿 吴琨 刘斌 张世庆 SUN Jiayi;WU Kun;LIU Bin;ZHANG Shiqing(Center for Medical Device Evaluation,NMPA,Beijing,100081)

机构地区：[1]国家药品监督管理局医疗器械技术审评中心,北京市100081

出　　处：《中国医疗器械杂志》2021年第1期62-66,共5页Chinese Journal of Medical Instrumentation

摘　　要：IMDRF组织修订《医疗器械安全和性能的基本原则》(以下简称《基本原则》),进一步推动了国际医疗器械安全有效认识的统一。为加强医疗器械技术审评科学性,加深对《基本原则》的理解,对《基本原则》进行介绍,重点阐述其在我国医疗器械注册法规体系中的作用,以及与质量管理体系建设、风险受益判定以及注册申报的联系,分析其在医疗器械注册申报实际应用中存在的问题及原因,并为促进《基本原则》的应用,提出相关建议。IMDRF revised the Essential Principles of Safety and Performance of Medical Devices and IVD Medical Devices(hereinafter referred to as"EP"),which further promoted the unification of medical device safety and effectiveness internationally.In order to strengthen the scientific review of medical device and deepen the understanding of EP,we introduce EP,focus on the role of EP and the connection with the construction of quality management systems,risk and benefit determination,and registration,analyze the problems and reasons in the process of medical device registration,and give suggestions to promote the application of EP.

关 键 词：医疗器械 安全和性能 风险 受益 质量管理体系 

分 类 号：F203[经济管理—国民经济]