中美医疗器械标准管理对比研究与启示  

A Comparative Study on the Standard Management of Medical Devices between China and the United States

作　　者：于欣[1] 母瑞红[1] 余新华[1] Yu Xin;Mu Ruihong;Yu Xinhua(National Institutes for Food and Drug Control,Beijing 102629,China)

机构地区：[1]中国食品药品检定研究院,北京102629

出　　处：《中国药事》2020年第8期877-881,共5页Chinese Pharmaceutical Affairs

摘　　要：目的:为医疗器械标准体系建设提供技术建议。方法:对比分析研究中美国家标准及医疗器械标准管理模式。结果与结论:通过中美标准管理模式对比分析,提出完善医疗器械标准体系建设建议,以此提高医疗器械标准管理水平。Objective:To provide a technical suggestions for the construction of medical device standard system.Methods:A comparative analysis for the national standard and the medical device management mode between China and the United States was conducted.Results and Conclusion:Through the comparative analysis of the standard management mode between China and the United States,some suggestions are put forward to improve the construction of the standard system of medical devices,so as to improve the standard management level of medical devices.

关 键 词：医疗器械 标准 标准体系 

分 类 号：R95[医药卫生—药学]