摘要
医疗器械唯一标识是当前全球医疗器械监管领域的热点,本文概括了唯一标识的国际进展和国家相关宏观政策,从我国唯一标识制度的建设和试点实施两方面介绍了我国唯一标识进展,为各方了解唯一标识相关知识,积极实施和应用唯一标识提供参考和借鉴。
Unique Device Identification(UDI)is a hot topic in the field of global medical device regulation.This article summarizes the progress of UDI on the global scale and national policies associated with UDI,and introduces development of the UDI system in China and the pilot program for UDI implementation.The authors hope to provide relevant information to stakeholders and promote implementation of the UDI system.
作者
易力
黄伦亮
余新华
YI Li;HUANG Lun-liang;YU Xin-hua(National Institutes for Food and Drug Control;National Medical Products Administration)
出处
《中国食品药品监管》
2021年第3期28-35,共8页
China Food & Drug Administration Magazine
