医疗器械网络销售

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网售医疗器械新规落地 守护公众购械“云端”安全
Zhong Guo Xin Wen Wang· 2025-10-02 01:11
Group 1 - The core viewpoint of the articles highlights the implementation of the "Medical Device Online Sales Quality Management Specification" on October 1, which aims to establish clearer safety standards for the rapidly growing online medical device sales sector [1] - The number of companies engaged in online sales of medical devices in China has surged from 8,717 in 2018 to over 360,000, while the number of third-party platform companies has increased from 77 to over 800 [1] - The new specification consists of four chapters and 50 articles, providing specific guidance on common industry issues, helping companies fulfill their responsibilities, and promoting healthy market development [1] Group 2 - Zhejiang Province previously introduced the "Compliance Guidelines for Online Sales of Medical Devices (First Edition)," which includes 29 specific provisions to serve as a practical "operating manual" for companies [2] - The guidelines establish five basic principles: legal compliance, prioritizing quality and safety, ensuring accurate information, maintaining risk control throughout the process, and fully protecting consumer rights [2] - The Zhejiang Provincial Drug Administration has issued reminders for consumers to check the qualifications of sellers and products, choose legitimate platforms, and retain transaction receipts when purchasing medical devices online [2]
《医疗器械网络销售质量管理规范》政策解读发布
news flash· 2025-05-09 10:36
国家药监局今天发布《医疗器械网络销售质量管理规范》政策解读,对《规范》出台的背景、总体思 路、主要内容、销售有特殊验配要求医疗器械的要求、网络销售经营者的责任、经营主体信息公示要 求、电商平台经营者的人员配置和机构设置方面的要求,以及违法违规处置和安全风险管理等方面,向 公众做出详细说明。近年来,我国医疗器械网络销售市场迎来爆发式增长。据统计,从2018年至今,从 事网络销售的医疗器械经营企业由8717家增至36万余家,第三方平台企业由77家增长至851家。(央视新 闻) ...