NMPA Issues Guidelines for On-Site Inspections Under the Good Practice for the Online Sale of Medical Devices

The National Medical Products Administration (NMPA) has recently issued the Guidelines for On-Site Inspections Under the Good Practice for the Online Sale of Medical Devices (the "Guiding Principles"), together with a notice to specify the related arrangements.

The Guidelines apply to supervisory inspections conducted by medical products regulatory authorities on online medical device sellers and e-commerce platform operators. The document specifies detailed inspection items and priorities corresponding to the provisions of the Good Practice for the Online Sale of Medical Devices, with key items clearly identified. It also sets out three possible inspection outcomes: "Passed," "Rectification within a Time Limit," and "Failed." In cases of "Failed," medical products regulatory authorities may publicly disclose the inspection results and conduct accountability interviews with the legal representative or principal person in charge of the relevant online medical device seller or e-commerce platform operator. If the inspection reveals potential risks to medical device quality and safety, the authorities will take action in accordance with applicable regulations.



(Source: https://www.nmpa.gov.cn/xxgk/fgwj/gzwj/gzwjylqx/20250926145725125.html)

Note: The link to the Chinese official website of the document is for your reference.