我国医疗器械临床评价工作的问题与思考

Clinical evaluation of medical devices in China

介绍了国内临床评价监管法规和监管工作的概况。通过对当前部分监管人员和注册申请人在临床评价工作及法规解读中存在的误解进行分析、纠正,使注册申请人能够更加科学、合理地编写临床评价报告,节约申请人的资金成本和时间成本。最后提出了几点建议,以期使国内医疗器械临床评价工作更科学、更具操作性。

The status of clinical evaluation supervision laws and regulations in China was introduced. The misunderstandings of the supervisor and register proposer in clinical evaluation supervision laws and regulations were analyzed and corrected, so that the proposer could write the clinical evaluation report correctly with the cost for time and fund reduced.Some suggestions were put forward to improve clinical evaluation of medical devices in China.