文档介绍：
美国唯一医疗器械标识规则介绍及启示
刘清峰*
(上海医疗器械高等专科学校管理系,上海 200093)
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摘要:唯一医疗器械标识在医疗器械产品上市后监管中起重要作用,受到各国政府监管部门
的重视,本文阐述了唯一医疗器械标识的概念,列表总结了相关医疗器械产品的合规日期,
认为 UDI 的实施可以减少医疗差错,将医疗器械使用信息的整合简化为数据系统,促使医
疗器械不良事件的快速鉴定,促使所报告问题的解决方案的快速推进,促使器械召回方案快
速有效地解决,FDA 的安全警示可以更具针对性和有效性。详细介绍了 FDA 颁布的 UDI
规则的内容。结果表明我国应尽快颁布实施 UDI 系统,相关企业应尽快学习和应用 FDA 颁
布的 UDI 规则,通过加强管理稀释成本来提高经济效益。
关键词:卫生事业管理;美国 FDA;UDI 规则;启示
中图分类号:R19
Introduction of the Device Identification and
Enlightentment
Liu Qingfeng
(Management Department,Shanghai Medical Instrumentation College, Shanghai 200093)
Abstract: As a medical device product identification symbol, Unique Device Identification plays
an important role in the regulatory affairs. In order to offer inspiration for medical devices
enterprises and Chinese regulatory government for medical devices, this paper discussed the
concept and gave a summary pliance dates for the Final Rule. It believed that UDI could
reduce medical errors, simplify the integration of device use information into data systems,
provide for more rapid development of solutions to reported problems, provide for more rapid,
more efficient resolution of device recalls, better focused and more effective FDA safety
communication. It also introduced the relevant rules issued by the FDA about medical device
Unique Device Identification. The results showed that China should issue Chinese UDI system as
soon as possible,related enterprises should learn and apply UDI rules and improve efficency by
enhencing management and diluting cost.
Key words: Health Management; the . FDA;the rule of UDIs;enlightenment
0 引言
唯一医疗器械标识(Unique Device Identification,缩写为 UDI)作为一种产品标识符号,
在医疗器械产品上市后监管起重要作用,受到各国政府监管部门的重视[1]。2013 年 9 月 24
日,美国政府颁布了唯一医疗器械标识最终规则(Unique Device Identification System; Final
Rule,以下简称 UDI 规则)[2]。本文就美国食品药品监督管理局(以下简称美国 FDA 或 FDA)
实施 UDI 的规则进行介绍,在此基础上建立起给我国的启示。
1. 唯一医疗器械标识(UDI)简介
唯一医疗器械标识(UDI)的概念
唯一医疗器械标识是英文 Unique Device Identification