医疗卫生装备2018，Vol.39Issue(1)：77-81,5.DOI:10.7687/j.issn1003-8868.2018.01.077
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
摘要
Abstract
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Key words
medical device/policies and regulations/enterprise scale/product filing and registration/industry development environment分类
医药卫生引用本文复制引用
蒋海洪,徐键..政策法规变动对医疗器械产业的影响研究[J].医疗卫生装备,2018,39(1):77-81,5.基金项目
中国药品监督管理研究会资助项目(CSDR-Q XJG-2017-0005) （CSDR-Q XJG-2017-0005）
