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

      Brief Discussion on the General Requirements of Quality Management System of In Vitro Diagnostic Reagents Developed by Medical Institutions

      • 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。

         

        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.

         

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