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[Current situation and consideration of medical instrument clinical trial in China]
Zhong-Ge Xiao1, Li-Ming Zhou, Zhou-Ping Tian
1Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University, Shanghai. zgxiao99@yahoo.com
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.
Results & 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.
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