摘要
在对政府规制和行政许可基本理论进行总结分析的基础上,从公共利益至上、许可法定、许可公开、公正与公平、效率与便民、许可与监督相结合等方面,就其对中国医疗器械注册管理工作带来的启示进行了初步探讨。
Based on the theories of the Government Regulation and Administrative Licensure, focusing on the public interests first, licensure set by law, openness to public, justness and fairness, eflfciency and convenience, and combination with post-surveilance, some concepts and principles for the medical device registration system in China were discussed.
出处
《中国药物警戒》
2012年第11期655-661,共7页
Chinese Journal of Pharmacovigilance
关键词
医疗器械
注册管理
政府规制
行政许可
medical device
registration
government regulation
administrative licensure
