用“类案同判”法治思维构建医疗器械技术审评技术规范体系的思考  

Considerations on Constructing the System of Evaluation of Medical Devices with the Rule of Simultaneous Judgment in Similar Cases

作　　者：吕允凤 邓刚 LV Yun-feng;DENG Gang(Center for Medical Device Evaluation,NMPA,Beijing 100081)

机构地区：[1]国家药品监督管理局医疗器械技术审评中心,北京100081

出　　处：《中国医疗器械信息》2022年第11期1-3,共3页China Medical Device Information

摘　　要：“类案同判”是指法官正在审理的案件,应当与其所在法院和上一级法院已经审结的或者其他具有指导意义的同类案件裁判尺度一致。同样,对于医疗器械技术审评来说,相同品种的审评尺度应当把握一致,也是保证审评审批公正性的必要要求。医疗器械产品具有品种多、发展快、专业性强等特点,如何建立更为准确、覆盖面更广的审评技术规范体系,使得审评更科学、更有原则,可以借鉴“类案同判”的法治思维,将审评要点的体系与指导原则体系相结合,建立动态更新的审评技术规范体系。Simultaneous judgment in similar cases refers to the case that the judge is trying,which should be in accordance with the judgment standards of similar cases that have been concluded or have other guiding significance.Similarly,for the technical review of medical devices,the review standards of the same products should be consistent,which is also a necessary requirement to ensure the fairness of review and approval.The characteristics of medical device products are many varieties,rapid development,and strong professionalism.How to establish a more accurate and more comprehensive review basis system to make the review process more scientific and more principled?We can learn from the rule of law thinking of“simultaneous judgment in similar cases”and combine the system of mainpoints of technical review with the guideline system to establish a dynamically updated review basis system.

关 键 词：医疗器械技术审评 监管科学 审评要点 

分 类 号：R197.39[医药卫生—卫生事业管理]