积极探索我国医疗器械监管新模式

An Active Exploration of New Administrative Modalities on Medical Devices in China

通过借鉴世界发达国家医疗器械监管的特点。分析我国医疗器械监管方法与世界发达国家之间存在的差距,着重阐述医 疗器械生产企业监管模式的构建,提出了建立动态化管理、闭环式管理、层次化管理、一体化管理的体系,提出了建立 政府告知、企业承诺、符合性评估的企业许可审批制度等监管方式。

With respect to administrative modalities in developed countries and on the basis of the analysis of the gap in administration between China and developed countries, the paper explicates the establishment of administrative modalities for medical device manufacture, raises up the idea of dynamic management, loop management, tiers management and integration management. The paper also presents a variety of administrative modalities on qualification based manufacture license, i.e. government notice, manufacturer commitment, compliance evaluation.