Foryou Medical Contributes to Two Group Standards for Recombinant Collagen

On July 16, 2026, the China Food and Drug Corporation Quality and Safety Promotion Association approved and issued two group standards for recombinant collagen:T/FDSA 0185-2026, General requirements of the purification process for recombinant collagen protein and T/FDSA 0187-2026, Purity requirements and detection method (HPLC) for recombinant collagen.Both standards officially came into effect on August 16, 2026. Huizhou Foryou Medical Devices Co., Ltd. participated in the drafting and development of both standards as one of the drafting organizations.

The two standards focus on two key aspects of recombinant collagen: purification processes and purity testing. T/FDSA 0185-2026 establishes general requirements for the development, validation, production, and quality control of recombinant collagen purification processes, while T/FDSA 0187-2026 specifies requirements for determining recombinant collagen purity using high-performance liquid chromatography (HPLC). Together, the standards provide technical references for the research and development, manufacturing, and quality control of recombinant collagen-related products.

Foryou Medical's participation in the development of these standards is supported by its continued technical expertise in collagen and biomaterials. In recent years, the company has leveraged genetic engineering technologies to develop recombinant Type III and Type I collagen and has continued to advance research into their product applications. The company’s self-developed recombinant collagen liquid dressing obtained a medical device registration certificate in April 2025. Foryou Medical also has extensive experience in the research, development, and commercialization of animal-derived collagen.

The publication and implementation of these two group standards provide clearer technical guidance for recombinant collagen purification processes, purity testing, and quality control. For Foryou Medical, participation in their development represents not only a consolidation of its technical experience, but also a concrete contribution to industry standardization by incorporating its experience in R&D, manufacturing, and quality management into the development of industry standards.

Looking ahead, Foryou Medical will continue to advance innovation in advanced wound care, with ongoing investment in biomaterials research, product development, and quality management, supporting the translation of innovative technologies into clinical applications.