NMPA to Issue Quality Management Specifications for Online Sale of Medical Devices

On September 18, 2023, the National Medical Products Administration (“NMPA”) released the Quality Management Specifications for Online Sale of Medical Devices (Exposure Draft) to solicit public comments until October 14, 2023.

Consisting of 74 articles in four chapters, the document standardizes the quality management of online sales operators and platform operators, and clarifies that online sales operators shall establish and improve their quality management systems and information management capabilities that are commensurate with their business scope and scale. The document also clarifies the requirements for platform operators in relation to the management system, information disclosure, quality control, after-sales, recall and self-operation.