Recently, Yaohai Novagen has completed the registration of medical device master files (registration number: M2024092-000) at the Medical Device Technical Review Center of the State Food and Drug Administration for the fully human sequence "recombinant type III humanized collagen" medical device raw material expressed by fermentation and purification in the Pichia yeast system.

Medical device master file registration means that before putting a medical device on the market, the manufacturer or applicant submits detailed technical documents and supporting materials to the relevant regulatory authorities to prove that its products comply with regulations and standards. The owner of the master document can authorize the medical device registration applicant to cite it as part of the registration application materials when applying for medical device registration and other matters. Medical device manufacturers can quickly select raw materials during product research and development registration and application, avoid repeated submission and review of relevant technical information, optimize the registration application process, and significantly shorten the time to market for products.

The successful registration and use of Yaohai Novagen's "recombinant humanized type III collagen" medical device raw material shows that Yaohai Novagen's recombinant humanized type III collagen can be used as one of the standard raw materials for the design and development of other domestic medical device products. This milestone event marks that Yaohai Novagen has made significant progress in the field of medical device research and development, demonstrating that Yaohai Novagen's recombinant humanized type III collagen raw material has excellent product properties and quality standards, and represents that Yaohai Novagen has stepped up to a new level in the field of medical device development and is striding into the fast lane. In the future, the company will continue to explore research and development, accelerate the development of innovative biomaterials business segments, and promote the development of my country's biomedicine and pharmaceutical equipment fields!