医用磁共振成像系统临床评价指导原则与通用指导原则的异同分析

Analysis of Similarities and Differences between Guidance of Magnetic Resonance Diagnostic Devices Clinical Evaluation and Guidance of Medical Device Clinical Evaluation

医疗器械临床评价在医疗器械整个生命周期过程中发挥着重要的作用。该文对国家食品药品监督管理总局发布的医疗器械临床评价技术指导原则和医用磁共振成像系统临床评价技术指导原则做了介绍,对两个指导原则的异同进行了比较分析。既阐述了两者框架结构方面的异同,也阐述了条款内容方面的异同。特别是同品种产品定义、临床评价方法及差异性支持资料方面的异同。通过比较可使注册申请人的临床评价工作更科学合理,同时也可对食品药品监督管理部门撰写具体产品临床评价指导原则有所借鉴。

Clinical evaluation of medical devices plays an important role in the life cycle of medical devices. This paper introduces guidance of magnetic resonance diagnostic devices clinical evaluation and guidance of medical device clinical evaluation issued by CFDA. Their similarities and differences of the framework and content are analyzed, especially the definition, clinical evaluation methods and support data. By comparison, the clinical evaluation work of registration applicants can be more scientific and reasonable. At the same time, it can also be used for reference by the food and drug administration departments in evaluating the clinical evaluation of other products.