浅谈创新型治疗类医疗器械中临床试验设计的注意要点

随着产业的升级转型,创新型治疗类医疗器械日益增多。随着医疗器械监管逐渐到位,绝大多数此类产品在注册申报时需要进行规范的临床试验。在进行临床试验设计时,需注意试验设计要点。文章通过查阅相关注册法规、指导原则、国内外公开资料,结合相关项目经验,对此类医疗器械在临床试验设计中出现的问题进行相关探讨,以期对该类产品的临床试验设计提供参考。

Discussion on the Clinical Trial Design in Innovative Medical Devices

With the upgrading and transformation of the industry,the innovative medical devices are increasing day by day.And as the regulation of medical devices is gradually in place,most of these products require standardized clinical trials when they are registered.There are many considerations that need to be paid attention to in the design of clinical trials.The paper discusses the problems in the clinical trial design of this kind of medical devices,so as to provide reference for the clinical trial design of this kind of products.