摘要
鉴于国内各省级局的医疗器械技术审评机构在组织架构、技术人员队伍建设、专业背景及法规理解等差异较大,统一审评尺度一直是医疗器械审评审批制度改革的应有之义。梳理分析美国食品药品监督管理局(FDA)第三方510(k)审核项目,从其审评流程对第三方审核机构的监管等进行研究,并对该项目的运行绩效与常规510(k)审核进行比较分析,以推动我国医疗器械审评制度的改革与发展。在国内医疗器械审评审批制度改革中,借鉴FDA经验在全国审评机构范围内实施有效的审评制度,借助第三方机构完善第一类医疗器械产品备案工作,开展第三方审评,优化省级审评审批能力考核并推动审评信息共享与技术交流等,加快医疗器械产业高质量发展。
The differences of organizational structure,team construction of technician,professional background and understanding of regulations among various provincial institutes of technique evaluation of medical device were larger.And the unified standards of evaluation are the responsibility of the reform of the evaluation and approval system of medical device.The third party 510(k)audit project of American Food and Drug Administration(FDA)was sorted out and analyzed,and the supervision on the third party audit institute was studied from its’evaluation flow.And the operation performance and routine 510(k)audit of this project were compared and analyzed so as to promote the reform and development of the evaluation system of China.In the reform of the domestic evaluation and approval system of medical device,the experience of FDA should be referred to implement effective evaluation system within the nationwide evaluation institutes.And the third party institute should be used to improve the works of product recording of the first kinds of medical devices,and to develop the evaluation of the third party,and to optimize the ability check of evaluation and approval of provincial level and promote the information sharing and technical exchange of evaluations,and to accelerate the development with high quality of the industry of medical device.
作者
俞卉
袁鹏
杨挺
朱文武
YU Hui;YUAN Peng;YANG Ting(Department of Evaluation I,Evaluation center of medical device in Zhejiang Province,Hangzhou 31112,China;不详)
出处
《中国医学装备》
2021年第5期191-195,共5页
China Medical Equipment
基金
浙江省食品药品监督管理局科技计划项目(2018023)“我国医疗器械评审模式改革研究”。
关键词
第三方510(k)审核
医疗器械审评审批
制度改革
产品备案
审评信息共享
The 510(k)Third Party Review Program
The review and approval of the medical device
System reform
the record of class I medical devices
The availability of review information
作者简介
俞卉,女,(1992-),硕士,工程师,研究方向:医疗器械技术审评;通信作者:朱文武,cool.wenwu@qq.com。
