Chinese Journal of Pharmacovigilance ›› 2012, Vol. 9 ›› Issue (11): 655-661.

• Orginal Article • Previous Articles     Next Articles

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

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