取消第三类医疗技术准入审批的做法

Innovation and Management of Third Type of Medical Approaches After Administrative Approval Cancelled

2015年5月14日,国家卫计委印发"取消第三类医疗技术临床应用准入审批"通知,明确禁止和限制临床应用的第三类医疗技术项目的范围,强调医疗机构承担主体责任,加强事中事后监管工作。对第三类医疗技术审批取消后的相关法律法规缺位、后续实践中伦理委员会的作用和动态管理、再评价综合管理模式等未明确规定的问题进行探讨。

The approval of clinical application of third type medical approaches was cancelled in the notification delivered by the national health and family planning commission in May 14 nd,2015. The notification reaffirmed the forbidden or restrained scopes of clinical application of third type medical approaches,the hospital＇s responsibility and administrative supervision all the times. The aim of this study is to probe into the related laws and regulations,the roles of ethics committee,and integrated management after the cancellation of the approval of clinical application of third type medical approaches.