摘要
目的研究我国2014年国务院发布的《医疗器械监督管理条例》(国务院650号令),系统评价其对医疗器械市场准入的要求。方法采用系统评价的层次分析法,从注册、注册变更、延续注册等七个方面的要求进行分析,并与我国要求进行比较。结果与结论《医疗器械监督管理条例》的制定体现了规制理论中根据风险分别加强规制和放松规制的思路,在许可法定、许可效率和便民、许可与监督相结合方面进行了有益的改革。为保证其能够有效地被落实和执行,必须重点做好其配套法规的修订工作,建立以《医疗器械监督管理条例》为纲领,以局令、规范性文件和指导原则为依托的全面法规体系。
OBJECTIVE To study the regulation law＂medical device regulation＂（ State Council Decree No. 650） published on 2014,thus system reviews its impacts on the medical devices premarket evaluation in China. METHODS Based on system theory and analytic hierarchy process,an analysis is carried out on seven aspects including premarket evaluation,change of registration,continuation of registration,also a comparative study made with international practice. RESULTS AND CONCLUSION ＂Medical device regulation＂aim to strengthen and loose regulation based on the risk of medical devices,which is an application of regulation theory. In order to apply the new lay effectively,supporting regulations should be carefully designed and organized,thus make a comprehensive regulation system with laws,regulations and guidance documents.
出处
《中国药学杂志》
CAS
CSCD
北大核心
2015年第24期2166-2169,共4页
Chinese Pharmaceutical Journal
基金
辽宁省社会发展攻关计划"辽宁省医疗器械产品市场准入路径优化研究"资助项目(2011225028)
关键词
医疗器械
监督管理条例
市场准入
规制
系统评价
medical devices
supervision and regutation
premarket evaluation
regulation
system review
