医疗器械唯一标识对植入性医疗器械溯源管理中的应用分析  

Medical Device Unique Identification(UDI)Analysis of Implantable Medical Device Traceability Management

作　　者：陈季亨 郑芙蓉 谢晓东 CHEN Ji-heng;ZHENG Fu-rong;XIE Xiao-dong(Quanzhou Bone-Setting Hospital,Fujian Quanzhou 362000)

机构地区：[1]泉州市正骨医院,福建泉州362000

出　　处：《中国医疗器械信息》2024年第9期139-141,共3页China Medical Device Information

摘　　要：医疗器械唯一标识被称为医疗仪器的电子身份证,在我国医疗器械行业发展过程中,需要推广医疗器械唯一标识的应用。当前我国出台了相关政策法规,提出了医疗器械唯一标识实施的意义和基本要求。但是医疗器械类型较多,企业需要结合实际情况制定科学的计划方案。文章主要分析医疗器械唯一标识对植入性医疗器械溯源管理工作的应用与意义,以期促进医疗领域医疗器械唯一标识的推广利用,进而维护我国医疗器械行业发展的稳定性。The unique identification of medical devices is known as the electronic ID card of medical devices.In the development process of China’s medical device industry,the application of unique identification of medical devices needs to be promoted.In the current period,China has issued relevant policies and regulations,and put forward the significance and basic requirements of the implementation of the unique identification of medical devices.However,there are many types of medical devices,and enterprises need to formulate scientific plans based on the actual situation.This paper mainly analyzes the traceability management of implantable medical devices by unique identification of medical devices(UDI),and promotes the use of unique identification of medical devices in the medical field to ensure the stability of the development of China’s medical device industry.

关 键 词：医疗器械 唯一标识 植入性医疗器械 溯源管理 

分 类 号：R197.39[医药卫生—卫生事业管理]