文档介绍：
美国 FDA 唯一医疗器械标识数据库相关规
则及启示
刘清峰*
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(上海医疗器械高等专科学校管理系,上海 20093)
摘要:唯一医疗器械标识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,
为给我国企业和政府监管部门以启示,阐述了了唯一医疗器械标识的概念及实施意义,列
出了各类各类医疗器械的合规日期,介绍了 FDA 关于唯一医疗器械标识数据库的相关规
则;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:卫生事业管理;唯一医疗器械标识数据库(UDID);规则;启示
中图分类号:R19
The Rule of the . FDA Medical Device Unique
Identification Database and Inspiration
Liu Qingfeng
(Management Department,Shanghai Medical Instrumentation College,200093)
Abstract: As a medical device product identification symbols, 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 the implementation significance of UDI made an induction of the UDI final rule
issued by FDA of the . and introduced the relevant rules issued by the FDA about medical
device Unique Device Identification Database. 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 (UDID); Rules;
Inspiration
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,
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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