By Fineline Cube 
The National Medical Products Administration (NMPA) has released the “Announcement on Quality Management Standards for Online Sales of Medical Devices,” which will take effect on October 1, 2025. The new standards aim to regulate and enhance the quality management of online medical device sales and e-commerce platforms.
Key Requirements for Online Sales Operators and E-commerce Platforms
Entities engaged in the online sales of medical devices and providing e-commerce platform services must adhere to principles of honesty and trustworthiness. They are required to ensure the authenticity, accuracy, completeness, and traceability of medical device information in online transactions. Both online sales operators and e-commerce platform operators must establish and continuously improve a quality management system that aligns with the new standards to ensure its effective operation.
Encouragement of Technological Innovation
The NMPA encourages the adoption of new methods and technologies, such as big data, cloud computing, and artificial intelligence, to implement quality control and enhance the quality management level of medical device online sales.
Additional Requirements for Wholesale Business
If online sales operators engage in the wholesale business of Class II and Class III medical devices, their quality management institutions must also review the qualifications of buyers and implement dynamic management.
Technical and Security Requirements
Network sales operators conducting online sales through self-built websites, clients, or applications must have computer systems, facilities, equipment, or technical conditions with functions such as data backup and fault recovery. They must also develop emergency plans for network security incidents. Relevant information systems and servers used for storing data must be located within the territory of the People’s Republic of China. Operators selling medical devices through e-commerce platforms must confirm the qualifications of the proposed operators, establish files for joining the e-commerce platform, and implement dynamic management.-Fineline Info & Tech