《医疗器械网络销售质量管理规范》政策解读发布

Core Viewpoint - The National Medical Products Administration (NMPA) has released an interpretation of the "Quality Management Standards for Online Sales of Medical Devices," detailing the background, overall approach, and key contents of the regulation [1] Group 1: Background and Growth - The online sales market for medical devices in China has experienced explosive growth in recent years, with the number of companies engaged in online sales increasing from 8,717 in 2018 to over 360,000 [1] - The number of third-party platform companies has also risen significantly, from 77 to 851 [1] Group 2: Key Contents of the Regulation - The regulation outlines specific requirements for medical devices that have special fitting requirements for online sales [1] - Responsibilities of online sales operators are clearly defined within the regulation [1] - There are requirements for the public disclosure of business entity information [1] - The regulation specifies personnel configuration and institutional setup requirements for e-commerce platform operators [1] Group 3: Compliance and Risk Management - The regulation includes provisions for handling violations and illegal activities [1] - It emphasizes the importance of safety risk management in the online sales of medical devices [1]