Current situation and consideration of medical instrument clinical trial in China / 中国医疗器械杂志

ABSTRACT

<p><b>OBJECTIVE</b>To improve the quality of medical instrument clinical trial in China.</p><p><b>METHODS</b>A systematic analysis on current situation of medical instrument clinical trial in China is conducted to find a way out of problems.</p><p><b>RESULTS & CONCLUSIONS</b>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.</p>