Based on the theories of the Government Regulation and Administrative Licensure,the current situation of medical device registration system in China were reviewed,the existing problems and weakness were found out, and finally some policy suggestions were provided as follows:①Change the concepts of medical device registration administration;②Perfect the regulations of medical device registration administration;③Reform the medical device review organizational system;④Optimize the procedure of review and approval;⑤Set up and maintain a professional team of review and approval staff;⑥Reinforce the post-marketing supervision of medical devices;⑦Foster and bring into play of the role of non-government organizations. <<