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国家药监局:进一步压实电商平台经营者对医疗器械网络销售质量管理责任
Shang Hai Zheng Quan Bao·2025-05-09 09:26

Core Points - The National Medical Products Administration (NMPA) released the "Quality Management Specification for Online Sales of Medical Devices" on April 28, which includes four chapters and fifty articles, focusing on quality management systems for online sales operators and e-commerce platforms [1][2] - The specification emphasizes the responsibilities of e-commerce platform operators in managing the quality and safety of medical devices sold online, including real-name registration of online sales operators and verification of their licenses and registrations [2] - The online sales market for medical devices in China has seen explosive growth, with the number of companies engaged in online sales increasing from 8,717 in 2018 to over 360,000, and third-party platform companies rising from 77 to 851 [2] Group 1 - The specification outlines the need for online sales operators and e-commerce platforms to establish and maintain a quality management system tailored to online medical device sales [1] - E-commerce platform operators are required to implement a quality management system that includes responsibilities for quality management personnel, system functionality, and continuous improvement processes [2] - The specification guides e-commerce platforms to enhance internal risk monitoring and external risk information analysis to improve medical device quality and safety risk management [3]