Study on the reform and improvement of the medical device registration system in China.
- Author:
Lanming WANG
1
Author Information
1. Department of Medical Devices Supervision, State Food and Drug Administration, Beijing 100053. sfdawlm@126.com
- Publication Type:Journal Article
- MeSH:
China;
Device Approval;
legislation & jurisprudence;
Equipment and Supplies;
Health Facility Administration
- From:
Chinese Journal of Medical Instrumentation
2012;36(6):426-432
- CountryChina
- Language:Chinese
-
Abstract:
Based on the theories of the Government Regulation and Administrative Licensure, aiming at the current situations of medical device registration system in China, some policy suggestions for future reform and improvement were provided as follows. (1) change the concepts of medical device registration administration. (2) perfect the regulations of medical device registration administration. (3) reform the medical device review organizational system. (4) Optimize the procedure of review and approval. (5) set up and maintain a professional team of review and approval staff. (6) reinforce the post-marketing supervision of medical devices. (7) foster and bring into play of the role of non-government organizations.
