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

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...

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Bibliographic Details
Main Authors: Ting HE, Ru BAI, Neng XIE
Format: Article
Language:zho
Published: Editorial Office of Chinese Journal of Medical Instrumentation 2025-03-01
Series:Zhongguo yiliao qixie zazhi
Subjects:
Online Access:https://zgylqxzz.xml-journal.net/article/doi/10.12455/j.issn.1671-7104.240397
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