摘要
通过将欧盟医疗器械监管新法规与现行指令进行对比,对欧盟医疗器械新法规的修订思路,特别是分类管理思路的变化进行分析探讨,为行业法规人员解读欧盟新法规提供技术支持,为我国进行中的分类管理改革提供参考。
By comparing new medical device regulations with existing directives in the European Union, the revising ideas of new EU medical device regulations, especially the changes of the classification management concepts, were analyzed to provide clues for the industry to interpret the new EU regulations, and references for the classification management innovation in our country.
作者
张春青
周良彬
王越
易力
杨婉娟
戎善奎
李静莉
ZHANG Chunqing;ZHOU Liangbin;WANG Yue;YI Li;YANG Wanjuan;RONG Shankui;LI Jingli(National Institute for Food Drug Control, Beijing, 1000502;Guangdong Medical Devices Quality Surveillance and Test Institute, Guangzhou, 51066)
出处
《中国医疗器械杂志》
2018年第3期202-205,共4页
Chinese Journal of Medical Instrumentation
关键词
医疗器械
分类管理
法规
欧盟
medical devices
classification management
regulation
the European Union
