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.
Requirements for Domestic Production of Certified Imported Devices
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.
Comprehensive Inspections and Quality Management System Equivalence
The medical products administration bureau will conduct comprehensive inspections of domestic registration applicants, following the procedures for verifying the quality management system of medical device registration. The focus will be on the substantive equivalence of quality management systems in the product design and development process, both domestically and internationally. If differences in the quality management system are identified between the products to be registered domestically and the important medical device products, the registration application must provide a detailed explanation, promising that these differences will not affect the registration items, and conduct a risk analysis to identify the main risk points and control measures. This ensures the product’s safety, effectiveness, and controllable quality.
Priority Handling for Innovative Medical Devices
For imported innovative medical device products manufactured within China in accordance with the document’s requirements, priority will be given to handling corresponding registration, production permits, and other related matters.- Flcube.com
