摘要
医疗器械的使用安全问题关乎患者的生命健康,其高风险性决定了建立追溯制度的必要性。近年来,我国已经陆续发布了关于加强医疗器械上市后监管和建设可追溯体系的各项方针政策,相关系统试点工作也在稳步推进。通过对美国和欧盟的药品及医疗器械追溯体系整体设计、政策法规和实施推进的工作经验的梳理研究,为我国医疗器械追溯体系建设提供参考。
The safety use of medical devices is related to the health of patients,and its high risk determines the necessity of establishing a traceability system.By studying the design and requirement of drug and medical device traceability system in European Union and the United States,this paper summarizes the advantages of each traceability system,and provide reference for the construction of medical device traceability system in China.
作者
马进
MA Jin(Information Center of National Medical Products Administration,Beijing 100044)
出处
《中国医疗器械信息》
2020年第19期4-6,24,共4页
China Medical Device Information
关键词
追溯体系
追溯平台
医疗器械
唯一标识
traceability system
traceability platform
medical devices
unique identification
