On April 28, 2025, the National Medical Products Administration (NMPA) of China released regulations outlining the basic requirements for the quality management of online sales of medical devices.
These regulations specify the requirements that apply to online sellers and e-commerce platform operators selling medical devices online in China.
The main contents of the regulation are as follows:
1. Quality Management for Online Sellers
1) Online sellers must establish a quality management organization that is appropriate for the scope of online sales, business model, and scale of sales.
2) The quality management organization of the online seller must perform the following roles in addition to those outlined in the medical device distribution and quality management regulations:
- Collect and supervise compliance with relevant laws, regulations, and standards related to the online sale of medical devices
- Develop, guide, supervise, and inspect the implementation of policies related to online sales quality management regulations, and continuously improve them.
- Verify and manage the certification and registration information related to the medical devices being sold.
- Monitor and address quality and safety risks associated with online sales.
- Investigate and handle quality-related complaints related to online sales.
3) The person responsible for online sales, the quality manager, and those in charge of quality management must meet the qualifications required by the medical device distribution and quality management regulations.
4) The online seller must have appropriate hardware, software, and technical conditions suitable for the scope and scale of the online sales, ensuring functions such as data backup and disaster recovery.
2. Quality Management for E-Commerce Platform Operators
1) E-commerce platform operators are legally responsible for ensuring the quality management of medical device online sales. When providing online transaction services for medical devices, they must require online sellers to comply with relevant laws and regulations.
2) The legal representative or key responsible person of the e-commerce platform operator holds the main responsibility for the quality and safety management of medical device online sales. They must ensure that the quality safety manager is able to perform an independent role.
3) E-commerce platform operators must establish a quality and safety management organization that is appropriate for the scale and risk level of the medical device online transaction services, and carry out its responsibilities accordingly.
This regulation will take effect on October 1, 2025.
Please refer to the attached document below.
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