[Study of the management of clinical trial in the registration of medical devices in China].
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.
Institute of Medical Information/Medical Library, Chinese Academy Of Medical Sciences & Peking Union Medical College Hospital, Beijing, 100020.
Ranran
R
Du
Zhaolian
Z
Ouyang
Kelei
K
Guo
Hui
H
Chi
D002681:China; D002986:Clinical Trials as Topic; D018795:Device Approval; D012107:Research Design