摘要
为给我国医疗器械监督管理以启示,本文采用内容分析法阐述了UDI的概念及其实施意义,对美国FDA颁布的UDI的最终规则做了介绍,列出了相关医疗器械产品合乎规则要求的日期。建议我国加快对医疗器械监督管理的立法步伐,医疗器械监管部门应将UDI系统列入专题研究,相关企业应尽快学习应用UDI规则。
In order to offer inspiration for medical devices supervision and management, this paper discussed the concept and implementation signiifcance of UDI, made a presentation of the UDI ifnal rule issued by FDA of the U.S., and listed a table of the compliance date of related medical device products to meet the requirements of this date. The results showed that China should accelerate the legislation pace of supervision and management of medical devices, China＆#39;s medical device regulatory authorities should take UDI system to be included in special studies, related enterprises should learn and apply UDI rules as soon as possible.
出处
《中国医疗器械信息》
2014年第4期37-42,共6页
China Medical Device Information
