In recent years, the industry's demand for encouraging innovation, optimising the registration process, and avoiding duplicate submission of registration data has been increased. In order to implement the ‘Opinions on Deepening the Reform of the Review and Approval System and Encouraging Innovation in Drugs and Medical Devices’ and ‘Opinions on Reforming the Review and Approval System of Drugs and Medical Devices’ of the General Office of the CPC Central Committee and the General Office of the State Council, the State Council has further improved the quality of the review and approval of medical devices and set up a more scientific and efficient review and approval system, to encourage innovation and to facilitate the selection of raw materials and key components for medical device manufacturers. To encourage innovation, facilitate medical device manufacturers to select raw materials and key components, and simplify the registration declaration, the National Medical Products Administration(NMPA) conducted in-depth research and listened to the views of all parties, and then on 12 March 2021, the NMPA issued a notice on the registration of medical device master files. The content of medical device master file mainly involves the research data of medical device raw materials, which is one of the core documents in the preparation and review and approval of medical device registration.
In response to the Announcement on the Registration of Medical Device Master File issued by the National Medical Products Administration, Soho Biotech has successively completed the registration of three master files, including ‘Master File for Silk Fibroin Lyophilized Raw Material’, ‘Master File for Silk Fibroin Raw Material’ and ‘Master File for Silk Fibroin Biomaterials’ in September 2022.
Silk Fibroin Lyophilized Raw Material is made of natural silk sericin without any chemical additives, which is suitable for the research in the application of silk fibroin. Silk Fibroin Raw Material is a high-purity silk fibroin solution prepared from natural mulberry silk after a series of purification processes.It can be used for the preparation of porous sponge scaffolds, films, gels, powders, micro-nanoparticles, etc.Silk Fibroin Biomaterials are microporous silk fibroin films made of silk, which are made of purified silk proteins after degumming and processed by freeze-drying process, and have good biocompatibility, flexibility, and effectively maintain the moist environment of the wound.The approval of the above three master files on silk fibroin materials proves that the application of silk materials in the high-end medical field has been recognised by the industry, and in the future, silk materials are expected to become a new platform-type material alongside synthetic materials, metal materials and materials from animal tissue sources, to provide a new direction for the selection of raw material materials for regenerative medical products.
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