[Study of the management of clinical trial in the registration of medical devices in China]

Ranran Du; Zhaolian Ouyang; Kelei Guo; Hui Chi

[Study of the management of clinical trial in the registration of medical devices in China]

Zhongguo Yi Liao Qi Xie Za Zhi. 2012 May;36(3):206-9.

[Article in Chinese]

Authors

Ranran Du¹, Zhaolian Ouyang, Kelei Guo, Hui Chi

Affiliation

¹ Institute of Medical Information/Medical Library, Chinese Academy Of Medical Sciences & Peking Union Medical College Hospital, Beijing, 100020.

PMID: 22916481

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.

Publication types

English Abstract
Research Support, U.S. Gov't, Non-P.H.S.

MeSH terms

China
Clinical Trials as Topic
Device Approval*
Research Design