网售医疗器械新规落地 守护公众购械“云端”安全

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]