摘要
为规范医疗器械唯一标识(unique device identification,UDI)系统建设,加强医疗器械全生命周期管理,国家药品监督管理局制定发布了《医疗器械唯一标识系统规则》,并于2019年10月1日起正式施行。创建UDI,需建立符合各利益相关方管理需求的UDI编码规则。本文采用内容分析法,综合分析了现行法规、标准对UDI编码的要求,并结合医疗器械产品生命周期内各方的管理需求,对如何进行UDI编码进行了阐述,并就编码过程中发现的问题,以及所收集到的现有市场上出现的UDI编码问题进行了讨论。建议相关企业应尽快学习UDI系统规则和标准,给产品赋予合规、合理的UDI编码,各UDI应用方应正确使用UDI编码,切实提升医疗器械识别的准确性,提升医疗器械管理的精细化程度,优化医疗器械供应链效率。
In order to standardize the construction of the unique device identification(UDI)system and strengthen the life cycle management of medical devices,the National Medical Products Administration(NMPA)has issued the Rules for the Unique Device Identification System,which is officially implemented from October 1,2019.To creat UDI,it is necessary to establish a UDI code rules that meets the management needs of various stakeholders.This paper uses content analysis method to comprehensively analyze the requirements of current regulations and standards for UDI coding,and explains how to carry out UDI coding in combination with the management needs of all parties in the life cycle of medical device products.At the same time,this paper discusses the problems found in the coding process,as well as the UDI coding problems that have emerged in the existing market.It is recommended that relevant enterprises should learn UDI rules and standards as soon as possible,and give products a compliant and reasonable UDI code.UDI applications should correctly use UDI codes to improve the accuracy of medical device identification and improve the level of medical device management,and optimize the efficiency of the medical device supply chain.
作者
李君
刘政江
LI Jun;LIU Zhengjiang(Shandong Weigao Group Medical Polymer Co.,LTD.Shandong Weihai 264210,China;People's Liberation Army No.970 Hospital,Shandong Weihai 264210,China)
出处
《中国医药导刊》
2019年第9期529-532,共4页
Chinese Journal of Medicinal Guide
