中国药物警戒 ›› 2012, Vol. 9 ›› Issue (11): 655-661.

• 政策与法规研究 • 上一篇    下一篇

政府规制和行政许可理论及其对中国医疗器械注册管理工作的启示

王兰明1, 王宿2   

  1. 1 国家食品药品监督管理局医疗器械监管司,北京100053；
    2 北京理工大学生命科学与技术学院,北京 100081
  • 收稿日期:2012-05-23 出版日期:2012-11-10 发布日期:2015-08-07
  • 作者简介:王兰明,男,研究员,医疗器械监管。

Discussions on Medical Device Registration in China Based on the Theories of Government Regulation an Administrative Licensure

WANG Lan-ming1 , WANG Su2   

  1. 1 Department of Medical Device Supervision, SFDA Beijing 100053, China;
    2 College of Life Science and Technology, Beijing Institute of Technology, Beijing 100081, China
  • Received:2012-05-23 Online:2012-11-10 Published:2015-08-07

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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。

关键词: 医疗器械, 注册管理, 政府规制, 行政许可

Abstract: 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, efficiency and convenience, and combination with post-surveilance, some concepts and principles for the medical device registration system in China were discussed.

Key words: medical device, registration, government regulation, administrative licensure