健康发展与政策研究2025，Vol.28Issue(1)：98-103,6.DOI:10.12458/HDPR.202407039
公立医院医疗机构自行研制体外诊断试剂的发展现况及政策建议
Development status and policy recommendations of in-house in vitro diagnostic reagents by public hospitals in China
摘要
Abstract
The development and use of in-house in vitro diagnostic(IVD)reagents developed by public hospitals play a vital role in the clinical diagnosis and treatment,which represent an important pathway toward high-quality development.This study reviewed and compared the regulatory policies regarding IVD reagents both domestically and internationally,and summarized the implementation of pilot programs in domestic hospitals following the enactment of the Regulation on the Supervision and Administration of Medical Devices(revised in 2021),with a focus on experience from Ruijin Hospital.Challenges identified in the current practice process include limited institutional testing capabilities,unclear verification standards,underdeveloped product commercialization and inadequate pricing mechanism.At the same time,it proposes policy recommendations such as developing practical guidelines,building a quality management system,enhancing the role of medical institutions,and exploring the commercialization pathways of in-house IVD reagents.关键词
体外诊断试剂/实验室自建检测方法/卫生政策Key words
in vitro diagnostic reagents/in-house testing methods/health policy分类
医药卫生引用本文复制引用
沈士祺,谢泽宁,刘志刚,孙斌..公立医院医疗机构自行研制体外诊断试剂的发展现况及政策建议[J].健康发展与政策研究,2025,28(1):98-103,6.基金项目
上海市卫生健康委员会2024年卫生健康政策研究课题科研项目(2024HP23) （2024HP23）
上海交通大学医学院附属瑞金医院广慈课题科研项目(KY2023654) （KY2023654）
上海交通大学医学院附属瑞金医院人才培育之星项目(2024PY154) （2024PY154）
