摘要
通过统计分析国内近两年医疗器械产品分类情况,探讨目前分类工作的主要特点和存在的问题,并结合当前我国医疗器械分类管理改革的要求,提出完善医疗器械分类管理工作的对策和建议,为提高分类工作质量和效率提供参考。
The paper supplies an annalysis on the general situation of medical device regulatory classifi cation in the last two years of China.The key features and problems of classification on medical device are iscussed,combined with requests of reform on medical device regulatory lassification,this paper puts forward some suggestions to improve the quality and efficiency on regulatory classification of medical device in China.
作者
王越
许慧雯
兰禹葶
张春青
母瑞红
李静莉
WANG Yue;XU Hui-wen;LAN Yu-ting;ZHANG Chun-qing;MU Rui-hong;LI Jing-li(Nation Institutes of Food and Drug Control (Beijing 100050))
出处
《中国医疗器械信息》
2017年第17期1-3,10,共4页
China Medical Device Information
关键词
医疗器械
分类
属性界定
监管
medical device
classification
attribute definition
supervision
