GHTF安全与性能基本要求在我国医疗器械注册审查中的应用

The Application to GHTF Essential Principles of Safety and Performance for the Medical Devices Conformity Assessment in China

目的:研究GHTF医疗器械安全与性能基本要求,为我国医疗器械注册审查工作提供借鉴。方法:采用文献研究的方法,对GHTF第一工作组发布的技术文件及进行综合分析,包括医疗器械安全与性能基本要求、医疗器械符合性评价原则、证明医疗器械安全和性能基本要求符合性的技术汇总文件(STED)。结果与结论:GHTF主张以"安全性能基本要求"为核心,以技术汇总文件STED为统领,从而保证注册审查工作的系统性,这是当今发达国家医疗器械管理的经验总结和研究成果;我们应制定符合国情的"安全与性能基本要求",研究行之有效的注册审查体系,为我国医疗器械注册工作的改革提供借鉴。

Objective： This article aim to study the essential principles of safety and perlbrmance draft by GHTF, thus imprnvc the medical devices confonmty asscssmentin China, Mcthods： Based on literature study, an analysis is carried out on GHTF guidance files especially ＂Essential Principles of Safety and Performance of Medical Devices＂,＂Principles of Conformity Assessment for Medical Devices＂ and ＂Summary Technical Documentation for Demonstrating Conformity tothe Essential Principles of Safety and Performance olMedical Devices（STED）＂. Conclusions：GHTF declares＂essential principles of safety and performance＂ as the core, ＂summary technical documentation＂ as the method, thus systemizes the conformity assessment process, which are the experiences and achievements of medical devices regulation in developed countries. We should build our essential principlesof safety and performancebased on China situation,and research applicable assessment system, in order to make suggestions to the medical devices regulation reform.