Current situation and consideration of medical instrument clinical trial in China.

Author: Zhong-Ge XIAO ¹ ; Li-Ming ZHOU ; Zhou-Ping TIAN ; Jian JIN ; Hui ZHU
Author Information

1. Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University, Shanghai. zgxiao99@yahoo.com
Publication Type:Journal Article
MeSH: China; Clinical Trials as Topic; standards; Equipment and Supplies; Humans
From: Chinese Journal of Medical Instrumentation 2009;33(5):369-371
CountryChina
Language:Chinese
Abstract:
OBJECTIVETo improve the quality of medical instrument clinical trial in China.
METHODSA systematic analysis on current situation of medical instrument clinical trial in China is conducted to find a way out of problems.
RESULTS & CONCLUSIONSThere 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.