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美国唯一医疗器械标识数据库规则及启示

发表时间:2014-06-15  浏览量:1775  下载量:597
全部作者: 刘清峰
作者单位: 上海医疗器械高等专科学校管理系
摘 要: 为给我国企业和政府监管部门以启示,阐述了唯一医疗器械标识(unique device identification,UDI)的概念及实施意义,列出了各类医疗器械的合规日期,介绍了美国食品药品监督管理局(Food and Drug Administration,FDA)关于唯一医疗器械标识数据库(unique device identification database,UDID)的相关规则。并指出我国应加快对医疗器械监督管理的立法步伐,相关企业应尽快学习和应用UDI规则。
关 键 词: 卫生管理学;唯一医疗器械标识数据库;规则;启示
Title: Rules of the USA medical device unique identification database and inspiration
Author: LIU Qingfeng
Organization: Management Department, Shanghai Medical Instrumentation College
Abstract: In order to offer inspiration for medical devices enterprises and Chinese regulatory government for medical devices, this paper discussed the concept and the implementation significance of unique device identification (UDI), and made an induction of the UDI final rule issued by Food and Drug Administration (FDA) of the USA and introduced the relevant rules issued by the FDA about medical device unique device identification database (UDID). The results showed that China should accelerate the legislation pace of regulatory for medical devices, and related enterprises should learn and apply UDI rules as soon as possible.
Key words: health management; unique device identification database; rule; inspiration
发表期数: 2014年6月第11期
引用格式: 刘清峰. 美国唯一医疗器械标识数据库规则及启示[J]. 中国科技论文在线精品论文,2014,7(11):1087-1091.
 
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