Recently, the official website of the Center for Medical Device Evaluation (CMDE) under the National Medical Products Administration (NMPA) announced that sodium polyglutamate for medical devices, independently developed by Freda Biotechnology, has successfully completed Master File registration (Master File Registration No.M2024350-000). This marks the first Master File registration for such product in China.

Medical Device Master File (MDMF) registration refers to the process where medical device manufacturers submit technical documentation, quality management system files, and other required materials to regulatory authorities for filing. This serves to demonstrate product compliance and regulatory conformity. The submission primarily includes technical documentation, quality management system files, biocompatibility test reports, and other materials that comprehensively describe the product's design, manufacturing processes, and quality control measures.

Next, the company will, in accordance with the raw material sector planning of the group, expand into more application areas of raw materials, and provide customers with more and better products and services.