第一类医疗器械产品备案常见分类问题浅析  

Analysis of Common Classification Issues in the Filing of Class Ⅰ Medical Device Products

作　　者：刘蕊 温莉茵 董谦 易力 汤京龙[1] 张春青[1] LIU Rui;WEN Li-yin;DONG Qian;YI Li;TANG Jing-long;ZHANG Chun-qing(National Institutes for Food and Drug Control,Beijing 100050)

机构地区：[1]中国食品药品检定研究院,北京100050

出　　处：《中国医疗器械信息》2025年第3期14-16,36,共4页China Medical Device Information

摘　　要：文章分析了几种第一类医疗器械在分类界定中的常见问题,以便于备案部门在实际工作中准确判断产品是否为第一类医疗器械,有利于准确开展第一类医疗器械备案及监管工作,助推医疗器械产业高质量发展。This article summarized several common problems in the classification and definition of medical devices of Class Ⅰ,so as to facilitate the accurate judgment of whether a product belongs to medical devices of Class Ⅰ by the medical products administration in practical work.It is conducive to the accurate recordation and supervision of medical devices of Class Ⅰ,and promotes the high-quality development of the medical device industry.

关 键 词：第一类医疗器械 医疗器械备案 

分 类 号：R197.39[医药卫生—卫生事业管理]