To medical products administrations of all provinces, autonomous regions and municipalities directly under the central government, and Xinjiang Production and Construction Corps:

To implement the Regulations for the Supervision and Administration of Medical Devices, the Provisions for Supervision and Administration of Medical Device Distribution, the Measures on Supervision and Administration of Online Sales of Medical Devices, and the Quality Management Specifications for Online Sales of Medical Devices, and to standardize and guide the on-site inspection work for the online sales of medical devices, the National Medical Products Administration (NMPA) has organized the formulation of the Guidelines for On-Site Inspection of the Quality Management Specifications for Online Sales of Medical Devices (hereinafter referred to as the "Guidelines"). These are hereby issued.

The Guidelines apply to the supervisory and inspection activities carried out by the departments responsible for drug supervision and administration in accordance with the law, targeting medical device online sales operators and medical device e-commerce platform operators. Considering that medical device online sales operators and e-commerce platform operators may differ in their business models, service methods, and scope of operations, during the inspection, operators may, based on their business models and characteristics, identify reasonable omissions in comparison with the Guidelines and give the reasons in writing for these omissions. The inspection team dispatched by the department responsible for drug supervision and administration will then confirm this.

During the supervision and inspection, if the medical device online sales operator or the medical device e-commerce platform operator meets all the applicable requirements or is able to make corrections on-site, the inspection result will be "Passed". If only general items (non-marked items) do not meet the requirements, or if there are < 3 non-compliant items in the key items (marked with ※), and the total number of non-compliant key items and general items is < 6, the inspection result will be "Rectification within a specified period". If there are 3 or more non-compliant items in the key items, or if there are non-compliant key items and the total number of non-compliant key items and general items is ≥ 6, the inspection result will be "Failed".

For enterprises with an inspection result of "Rectification within a specified period", they shall complete the rectification within the specified time frame and submit a rectification report to the department responsible for drug supervision and administration in a single submission. Upon receiving the rectification report, the department responsible for drug supervision and administration may, based on the actual situation, organize a re-inspection of the enterprise. If the rectification is confirmed to meet the requirements, the inspection result will be deemed "Passed". If the rectification report is not submitted within the specified time frame, or if the re-inspection finds that the rectified items still do not meet the regulations, the inspection result will be deemed "Failed".

For those deemed "Failed" in the inspection, the department responsible for drug supervision and administration may make the inspection results public and, in accordance with the law, conduct a responsibility interview with the legal representative or the primary responsible person of the medical device online sales operator or the medical device e-commerce platform operator. If the inspection reveals potential quality and safety risks with the medical devices, the relevant authorities will handle the matter in accordance with the applicable regulations.

If, during the inspection, it is found that the medical device online sales operator or the medical device e-commerce platform operator is in violation of the E-Commerce Law of the People's Republic of China, the Regulations for the Supervision and Administration of Medical Devices, the Provisions for Supervision and Administration of Medical Device Distribution, or other relevant laws, regulations, or rules, the department responsible for drug supervision and administration shall take legal action in accordance with the law.

National Medical Products Administration

September 25, 2025