Page 105 - 《中国医疗器械杂志》2025年第2期

Chinese Journal of Medical Instrumentation 2025 年 第49卷 第2期

监 管 与 测 试

文章编号：1671-7104(2025)02-0219-05

浅谈医疗机构自行研制体外诊断试剂

质量管理体系的通用要求

【作 者】 何婷，白茹，谢能
上海市医疗器械化妆品审评核查中心，上海市，200020
【摘 要】 2021年3月19日，国家药品监督管理局发布了《医疗器械监督管理条例》（中华人民共和国国务院令 第
739号），在第五十三条中明确规定了医疗机构自行研制体外诊断试剂的基本定义和使用范畴，并指出相关
管理办法由国务院药品监督管理部门会同国务院卫生主管部门制定。该举措标志着医疗机构自行研制体外
诊断试剂被重新纳入我国的监管体系。该研究回顾了国内外自行研制体外诊断试剂监管政策的发展历程，
并结合上海市药品监督管理局会同市卫生健康委员会发布的《上海市医疗机构自行研制体外诊断试剂现场
核查要点》以及备案前评估的具体核查工作，梳理了有关自行研制体外诊断试剂质量管理体系的通用要
求，旨在为该项试点工作的进一步开展以及全国范围的推广提供一定的参考。
【关 键 词】 医疗机构；自行研制体外诊断试剂；通用要求
【中图分类号】 F203; R197.39
【文献标志码】 A doi: 10.12455/j.issn.1671-7104.240397
Brief Discussion on the General Requirements of Quality
Management System of In Vitro Diagnostic Reagents
Developed by Medical Institutions
【 Authors 】 HE Ting, BAI Ru, XIE Neng
Shanghai Medical Device and Cosmetics Evaluation and Verification Center, Shanghai, 200020
【 Abstract 】 On March 19, 2021, the National Medical Products Administration(NMPA) issued the Regulations on the
Supervision and Administration of Medical Devices (Order No. 739 of the State Council of the People's
Republic of China), which clearly stipulated in Article 53 the basic definition and scope of use of in vitro
diagnostic reagents developed by medical institutions. It also pointed out that the relevant administrative
measures shall be formulated by the Drug Regulatory Department of the State Council in conjunction with
the Health Department of the State Council. This initiative marks the re-incorporation of in vitro diagnostic
reagents developed by medical institutions into China's regulatory system. This study reviewed the
development of regulatory policies for self-developed in vitro diagnostic reagents at home and abroad,
combined with the Key Points of On-site Verification of Self-developed In Vitro Diagnostic Reagents in
Shanghai Medical Institutions issued by the Shanghai Municipal Drug Administration, in conjunction with
the Shanghai Municipal Health Commission, and the specific verification work of pre-record evaluation,
and sorted out the general requirements for the quality management system of self-developed in vitro
diagnostic reagents. The purpose is to provide some references for the further development of this pilot
work and its nationwide promotion.
【Key words】 medical institution, self-developed in vitro diagnostic reagents, general requirements

0 引言 例》（中华人民共和国国务院令 第739号）（以下
简称《条例》）开始实施，《条例》第五十三条

2021年6月1日，新版《医疗器械监督管理条 明确了医疗机构自行研制体外诊断试剂（以下简
称“自制试剂”）的基本定义和使用范畴 。作为
[1]
收稿日期：2024-07-23 配套文件，《体外诊断试剂注册与备案管理办法》
作者简介：何婷，E-mail: kbqnht19890608@163.com
通信作者：谢能，E-mail: xieneng@yjj.shanghai.gov.cn （ 国家市场监督管理总局令 第48号）于2021年10月

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