CAJ | 학술논문

内容: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.
내용:목적:연구GHTF의료기계안전여성능기본요구,위아국의료기계주책심사공작제공차감.방법:채용문헌연구적방법,대GHTF제일공작조발포적기술문건급진행종합분석,포괄의료기계안전여성능기본요구、의료기계부합성평개원칙、증명의료기계안전화성능기본요구부합성적기술회총문건(STED).결과여결론:GHTF주장이“안전성능기본요구”위핵심,이기술회총문건STED위통령,종이보증주책심사공작적계통성,저시당금발체국가의료기계관리적경험총결화연구성과;아문응제정부합국정적“안전여성능기본요구”,연구행지유효적주책심사체계,위아국의료기계주책공작적개혁제공차감.
Objective:This article aim to study the essential principles of safety and performance draft by GHTF, thus improve the medical devices conformity assessmentin China. Methods: Based on literature study, an analysis is carried out on GHTF guidance files especial y“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 ofMedical 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.