Study of the management of clinical trial in the registration of medical devices in China.
- Author:
Ranran DU
1
;
Zhaolian OUYANG
;
Kelei GUO
;
Hui CHI
Author Information
1. Institute of Medical Information/Medical Library, Chinese Academy Of Medical Sciences & Peking Union Medical College Hospital, Beijing, 100020.
- Publication Type:Journal Article
- MeSH:
China;
Clinical Trials as Topic;
Device Approval;
Research Design
- From:
Chinese Journal of Medical Instrumentation
2012;36(3):206-209
- CountryChina
- Language:Chinese
-
Abstract:
The key factor responsible for the slowness of registration of medical devices in China is clinical trial. The clinical trial in European and U.S. is taken as an example to analyze the problems in clinical trials in China. Some suggestions are proposed to solve the problem.
