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新规下上海市医疗器械第三方物流质量管理关注点及问题解析

Analysis of the Concerns and Problems of Third-Party Logistics Quality Management of Medical Devices in Shanghai Under the New Regulations

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近年来,国家药品监督管理局先后出台了适用于医疗器械第三方物流企业的经营质量管理规范附录及配套指导原则,文章阐述了新规正式施行后,企业在质量管理方面需要重点关注的内容,并对几种现场检查中典型问题进行了解析,以供相关人士参考.
In recent years,the National Medical Products Administration(NMPA)has successively issued appendix and supporting guidelines for the quality management of medical device third-party logistics.This article elaborates on the key contents logistics companies should focus on in quality management after the official implementation of the appendix and guidelines.It also analyzes some typical problems to provide reference for industry supervisors and professionals.

medical devicesthird-party logisticsquality managementproblem analysis

刘雅婷、童美魁、杨宁宁

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上海市医疗器械化妆品审评核查中心 (上海 200020)

医疗器械 第三方物流 质量管理 问题解析

2024

中国医疗器械信息
中国医疗器械行业协会

中国医疗器械信息

影响因子:0.375
ISSN:1006-6586
年,卷(期):2024.30(13)
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