医疗器械飞行检查发现的问题及分析  

Brief Analysis of the Problems Existing in the Unannounced Inspection of Medical Device

作　　者：姜帆 JIANG Fan(Liaoning Center for Drug Evaluation and Inspection,Liaoning Shenyang 110036)

机构地区：[1]辽宁省药品审评查验中心,辽宁沈阳110036

出　　处：《中国医疗器械信息》2025年第3期4-6,28,共4页China Medical Device Information

摘　　要：通过对2024年开展30家医疗器械生产企业飞行检查中发现的主要问题进行汇总分析,了解生产企业质量管理体系存在的共性问题并提出整改建议,以推进企业按法规要求运行质量管理体系。The defects in the unannounced inspection existing in 30 different medical device manufacturers are classified and analyzed.This article summarizes the common problems existing in the operation of the quality system of manufacturers and gives corrective advices.It’s aimed to promote the operation of the quality system in the enterprises according to the requirements of laws and regulations.

关 键 词：医疗器械 飞行检查 问题分析 

分 类 号：R197.39[医药卫生—卫生事业管理]