国内医疗器械临床试验现状的分析

Analysis of current situation of medical device clinical trial in China

近年来,医疗器械临床试验开展数量上升趋势明显,为此国家药品监督管理局针对医疗器械临床试验进行了一系列的改革措施,监管路径也越趋规范和严格。本文主要从临床试验机构角度针对目前国内医疗器械临床试验的现状,从机构分布、监督管理、风险管理和行业不足几方面进行总结和分析,旨在为参与临床试验的各方提供参考。

In recent years,with the quantity increased significantly,more and more problems arisen in medical device clinical trials.Therefore,the National Medical Products Administration had carried out a series of reform measures for it,and the regulation measures was becoming more standardized and stringent.To provide reference for all parties involved in the implementation of clinical trials,this article summarizes and considers the current status of medical device clinical trial in China,including the distribution of institution,supervision,risk management and current shortcomings.