浅谈医疗器械标准信息化管理  

Discussion on Information-based Management of Medical Device Standard

作　　者：许慧雯[1] 郑佳[1] 兰禹葶 王慧超 余新华[1] XU Huiwen;ZHENG Jia;LAN Yuting;WANG Huichao;YU Xinhua(National Institutes for Food and Drug Control (Center for Medical Device Standardization Administration,NMPA),Beijing,102629)

机构地区：[1]中国食品药品检定研究院(国家药品监督管理局医疗器械标准管理中心)

出　　处：《中国医疗器械杂志》2019年第4期300-302,共3页Chinese Journal of Medical Instrumentation

摘　　要：该文浅析了医疗器械标准信息化管理在医疗器械标准制修订全过程精细化管理中的重要作用,介绍了目前医疗器械标准信息化管理工作的现状和医疗器械标准信息管理系统近年来升级完善的情况,提出了医疗器械标准信息化管理的工作思路和建议。The information-based management of medical device standards is of great significance for promoting the development of the medical device standardization. Here we analyzed the important role of the information-based management of medical device standards in the delicacy management of the whole process of establishing and modifying medical device standards, introduced its present situation and upgrade of information-based management system of medical device standards, and put forward work ideas and suggestions for it.

关 键 词：医疗器械 医疗器械标准 信息化管理 

分 类 号：F203[经济管理—国民经济] T-652.1[一般工业技术]