The National Medical Products Administration officially released the industry standard for tissue engineering medical device silk fibroin (2024 No. 120)
The National Medical Products Administration has officially released
Industry standard for tissue engineering medical device silk fibroin
No. 120 of 2024
Recently, the National Medical Products Administration issued Announcement No. 120 of 2024, stating that the industry standard for tissue engineering medical device silk fibroin (standard number: YY/T 1950-2024, hereinafter referred to as the "Standard") drafted by Zhejiang Xingyue Biotechnology Co., Ltd. has been approved and will be implemented from October 15, 2025.
Silk fibroin derived from natural silk not only has good biocompatibility, but also controllable biodegradability and low immunogenicity. It is rich in 18 amino acids, which help promote skin repair and cell regeneration. With the increasingly active research and application of silk fibroin in the field of medical devices, the requirements for its production, preparation, quality control, and other aspects have gradually increased. The release of this standard has successfully filled the gap in relevant standards in the medical field of silk fibroin.
This standard specifies the performance requirements, labeling, packaging, transportation, and storage requirements for silk fibroin used in tissue engineering medical device products, and describes the corresponding test methods applicable to the preparation of silk fibroin for tissue engineering medical device products.
During the formulation process, the standard participation team delved into the development of the silk fibroin medical field, extensively soliciting opinions and suggestions from various aspects such as medical device manufacturers, research institutions, and clinical users, ensuring the scientific, rational, and practical nature of the standard.
The National Medical Products Administration emphasizes that the safety of medical devices is closely related to public health, and the formulation and implementation of industry standards are of great significance for improving the quality of medical devices and promoting the healthy development of the industry. The release of this standard will further standardize and promote the healthy development of the silk fibroin medical device industry, and improve the quality and safety of related products. At the same time, it also provides support for relevant regulatory work, which helps to ensure the safety and rights of patients.
As one of the drafting units, Xingyue Biology has always adhered to a scientific and rigorous attitude, actively participating in the preparation and revision of standards. As of now, Xingyue Biotechnology has participated in drafting 2 industry standards, 1 group standard, and the international standard "Tissue engineered medical products - Characterization and evaluation of silk fiber as a starting material for TEMPs" that participated in drafting has officially entered the solicitation of opinions. In the future, Xingyue Biotechnology will continue to promote standardization in the silk fibroin industry, providing suggestions and recommendations to promote the development of the silk fibroin industry and improve the overall level of the industry. At the same time, we also look forward to working with more industry colleagues to jointly promote the prosperity of the silk fibroin industry.
