医疗器械电子说明书法规监管现状  

Domestic and Foreign Medical Device Electronic Instruction Manual Regulations Regulatory Status

作　　者：王森妹 李德全 陈勇强 柳永英 Wang Senmei;Li Dequan;Chen Yongqiang;Liu Yongying(Edan Instruments,Inc.,Shenzhen Guangdong 518122,China)

机构地区：[1]深圳市理邦精密仪器股份有限公司,广东深圳518122

出　　处：《医疗装备》2025年第5期43-47,共5页Medical Equipment

基　　金：深圳市科技计划项目(GJHZ20240218114608015)。

摘　　要：随着全世界范围内现代科技的数字化、智能化发展,部分国家和地区已经对某些医疗器械实施说明书电子化,将其作为纸质说明书的补充。医疗器械说明书的提供形式由纸质转向电子化,有利于提升说明书的监管效能和可维护性,并可促进生态环保。该研究阐述了国内外医疗器械电子说明书的相关监管法规和实施情况,分析了医疗器械电子说明书的施行意义,并探讨中国现阶段的支持性政策和面临的挑战,为医疗器械电子说明书的发展提供参考。With the development of digital intelligence in modern science and technology,some countries and regions in the world have implemented electronic instructions for certain medical devices as a supplement to paper instructions.The form of medical device instructions shifts from paper to electronic,which is conducive to improving the regulatory efficiency and maintainability of instructions and promoting ecological and environmental protection.This paper expounds the relevant regulatory regulations and implementation of electronic instructions for medical devices at home and abroad,analyzes the implementation significance of electronic instructions for medical devices,discusses the supporting policies and challenges at this stage in China,and provides reference for the development of electronic instructions for medical devices.

关 键 词：医疗器械 监管法规 电子说明书 

分 类 号：R955[医药卫生—药学]