Yang Pengfei, Wang Yanan, Sun Zhiyong, Zhang Yong, Meng Zhaoyang
Center for Medical Device Evaluation, CFDA, Beijing, 100081.
Liaoning Medical Device Test Institute, Shenyang, 110179.
Zhongguo Yi Liao Qi Xie Za Zhi. 2017 Sep 30;41(5):374-376. doi: 10.3969/j.issn.1671-7104.2017.05.017.
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.
医疗器械的临床评价在医疗器械的生命周期中发挥着重要作用。本文介绍了国家食品药品监督管理总局发布的磁共振诊断设备临床评价指导原则和医疗器械临床评价指导原则。分析了它们在框架和内容上的异同，特别是定义、临床评价方法和支持数据。通过比较，注册申请人的临床评价工作可以更加科学合理。同时，也可供食品药品监督管理部门在评估其他产品的临床评价时参考。
