The National Medical Products Administration (NMPA) has released a notification aimed at further clarifying the regulations surrounding the manufacturing of imported medical devices by companies within China. The document is open for public feedback until December 2, 2024.<\/p>\n\n\n\n
Requirements for Domestic Production of Certified Imported Devices<\/strong>
The document stipulates that for Category II or III imported medical devices that have been certified and are to be produced by enterprises within China, the registration applicant must promise that there will be no changes to the main raw materials and main production processes. Applicants are also required to provide a self-inspection report on the production quality management system of the products in China, ensuring compliance with the “Good Manufacturing Practice for Medical Devices,” and a comparison report on the quality management systems both domestically and internationally.<\/p>\n\n\n\n