Silk fibroin materials have been included in the national master document of medical raw materials

On March 12, 2021, the National Medical Products Administration issued a notice on the registration of medical device master documents. The main document of medical devices is one of the core documents in the preparation, review and approval of medical device registration, and its content mainly includes research materials for medical device raw materials.

In response to the National Medical Products Administration's announcement on the registration of medical device master documents, Zhejiang Xingyue Biotechnology Co., Ltd. completed two master document registrations, "" and "", in 2021, becoming one of the first domestic enterprises to complete the registration of medical raw material master documents.

Silk fibroin tissue repair material "is woven from mulberry silk, with a specific pore structure and mechanical strength, good biocompatibility and biosafety, and can be degraded and absorbed in vivo; Silk fibroin "is a type of silk fibroin produced through multiple mild processes in a GMP environment, with fibrous, solution like, and membrane like structural forms. The approval of the above two main documents on silk fibroin materials proves that the application of silk materials in high-end medical fields has been recognized by the industry. In the future, silk materials are expected to become a new platform type material that stands alongside synthetic materials, metal materials, and animal tissue source materials, providing new directions for the selection of raw materials for regenerative medical products.