我国医疗器械临床试验现状与思考  

Current Situation and Consideration of Medical Instrument Clinical Trial in China

作　　者：肖忠革[1] 周礼明[1] 田卓平[1] 金剑[1] 诸慧[1] 

机构地区：[1]上海交通大学医学院附属第九人民医院,上海市200011

出　　处：《中国医疗器械杂志》2009年第5期369-371,共3页Chinese Journal of Medical Instrumentation

摘　　要：上海交通大学医学院附属第九人民医院,上海市,200011目的:提高我国医疗器械临床试验的质量和水平。方法:分析我国医疗器械临床试验现状及存在问题,探讨解决办法。结果与结论:我国医疗器械临床试验现状表现为起点低、法规制度不完整,申办者和研究者不够重视,临床试验质量不高,需要在涉及医疗器械临床试验的各方面加以完善。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.

关 键 词：医疗器械 临床试验 伦理委员会 植入 管理 

分 类 号：R969.4[医药卫生—药理学] R197.39[医药卫生—药学]