In March 2021, the NMPA promulgated a regulatory notice on device master files. On January 18, 2023, they issued another notice titled – Further Clarity on the Registration and Use of Medical Device Master Files. Device Master Files are used to protect intellectual property for companies that make unique raw materials, device components, etc. While manufacturers of these items sell to final device makers, they want to keep their confidential processes (including manufacturing) separate from final device customers. The Chinese CMDE checks to make sure all required documents are provided and then issues a Master File number.
Most Master Files are used for Class 2 or Class 3 devices, clinical trial approvals, etc. Once the final device application is reviewed for approval, the CMDE will more carefully review the information in the Device Master File. Device Master Files include documents on the manufacturing process, chemical composition, mechanical and chemical performance, biocompatibility, etc. For device raw materials and component manufacturers that want to file to Master File but do not have their own office in China, an authorized local agent must do the submittal.