政策法规变动对医疗器械产业的影响研究  

Impacts of policy and regulatory changes on medical device industry

作　　者：蒋海洪[1] 徐键[2] JIANG Hai-hong;XU Jian(Shanghai University of Medicine&Health Sciences,Shanghai 201318,China;Shanghai University of Finance and Economics,Shanghai 200433,China)

机构地区：[1]上海健康医学院,上海201318 [2]上海财经大学,上海200433

出　　处：《医疗卫生装备》2018年第1期77-81,共5页Chinese Medical Equipment Journal

基　　金：中国药品监督管理研究会资助项目(CSDR-Q XJG-2017-0005)

摘　　要：目的:以国务院发布关于修订《医疗器械监督管理条例》的决定为契机,分析研究医疗器械政策法规的变动对行业产业的影响。方法:从产业企业规模、产品备案和注册数量、产业发展环境3个方面分析政策法规变动对医疗器械产业发展的影响。结果:政策法规的变动对产业企业规模的扩大影响不大,却使企业的备案与注册行为更加规范,产业发展的制度环境变严、发展环境趋向活跃。结论:基于医疗器械产品全生命周期的法规体系已经初步形成,医疗器械企业应该积极掌握新的法规变化,做好质量合规管理,潜心产品与技术的创新,利用好政策变动带来的红利。Objective To study the impacts of changes in medical device policies and regulations on the industry when the state department decides to revise Medical Devices Supervisory Management Act.Methods The impacts were discussed from the aspects of the scale of enterprise,number of product filing and registration and industry development environment.Results The changes of the policies and regulations had no great effect on the scale of enterprise while standardized the enterprise filing and registration and facilitated its development.Conclusion Management system based on medical device product lifecycle has been initially formed.Medical equipment enterprises should actively grasp the new regulatory changes and improve the quality compliance management by innovating product and technology,in order to make good use of the dividends brought about by changes in policies.

关 键 词：医疗器械 政策法规 企业规模 产品备案和注册 产业发展环境 

分 类 号：R318[医药卫生—生物医学工程] R197.39[医药卫生—基础医学]