NMPA to Regulate On-site Inspections under the Good Practice for the Online Sale of Medical Devices

The National Medical Products Administration (NMPA) has recently drafted the Guidelines for On-site Inspections under the Good Practice for the Online Sale of Medical Devices (Draft for Comment) (the "Draft"), which is now open for public consultation until August 30, 2025.

The Draft outlines 60 inspection items and key points of inspection, of which 29 are identified as critical. According to the Draft, inspectors should examine whether online sale operators of medical devices have established quality management organizations or designated quality management personnel, taking into account factors such as sales scale, business model, and the types and scope of medical devices sold. The setup of the organization or personnel staffing should align with the actual business operations. If a quality management organization has not been established, inspectors should check whether the online sale operator has issued appointment documents for quality management personnel and whether the job descriptions or responsibilities of those personnel cover quality management duties.



(Source: https://www.nmpa.gov.cn/xxgk/zhqyj/zhqyjylqx/20250806151011128.html)

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