摘要
目的介绍国家药品监督管理局医疗器械技术审评中心(简称“器械技术审评中心”)在统一审评尺度方面进行的实践和探索,供相关人士参考。方法分析现行体系存在的问题及采取的措施,介绍器械技术审评中心在医疗器械安全性方面进行尺度统一的案例。结果器械技术审评中心进一步完善质量管理体系,在统一审评尺度上进行了许多有益地探索。结论尺度统一是确保审评稳定和可重复的重要基础,通过制度的完善可有效促进审评尺度统一。
Objective To outline the practice and exploration carried out by the Center for Medical Device Evaluation,NMPA(CMDE)in the unified evaluation criterion so as to provide a reference for relevant parties.Methods The existing problems in the system and the measures taken were analyzed,and the case of uniformity about medical device safety in CMDR was introduced.Results The CMDE further improved the quality management system,and carried out a number of useful explorations on the unified evaluation scale.Conclusion The unification of criterion is an important basis for ensuring the stability and repeatability of the evaluation,and the improvement of the system can effectively promote the unification of the evaluation criterion.
作者
张世庆
王迎军
ZHANG Shiqing;WANG Yingjun(Center for Medical Device Evaluation of NMPA,Beijing 10081,China;NMPA Research Base of Regulatory Science for Medical Devices,NMPA Key Laboratory for Research and Evaluation of Innovative Biomaterials for Medical Devices,South China University of Technology,Guangzhou Guangdong 510006,China)
出处
《中国药物警戒》
2021年第11期1001-1003,1019,共4页
Chinese Journal of Pharmacovigilance
基金
重大新药创制国家科技重大专项2018年度(2018YFC1106701)。
