[Current situation and consideration of medical instrument clinical trial in China].
OBJECTIVE
To improve the quality of medical instrument clinical trial in China.


METHODS
A systematic analysis on current situation of medical instrument clinical trial in China is conducted to find a way out of problems.


CONCLUSIONS
There is a low level of medical instrument clinical trial now in China. There are still many shortcomings in law and regulations of medical instrument clinical trial. The sponsors and s do not know medical instrument clinical trial well, the measures of quality related to medical instrument clinical trial must be improved.
Xiao
Zhong-Ge
ZG
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University, Shanghai. zgxiao99@yahoo.com
Zhou
Li-Ming
LM
Tian
Zhou-Ping
ZP
Jin
Jian
J
Zhu
Hui
H
D002681:China; D002986:Clinical Trials as Topic / Q000592:standards*; D004864:Equipment and Supplies; D006801:Humans