I. Background of International Standard Development
On June 4, 2026, according to the National Standardization Administration, two international standard proposals, "Surgical Implants Recombinant Collagen" and "Surgical Implants Silk Fibroin Protein," led by Chinese experts, were officially approved. This marks the first time that an international standard system for recombinant collagen and silk fibroin protein in the global surgical implant field has been established.
China serves as the project leader for both standards, with experts from countries such as the United States, Germany, and France participating in their development, signifying that China is transitioning from an industry participant to an international rule-maker in the core biomaterial field of recombinant collagen.
II. Standard Content Framework
According to publicly available information, the two standards will establish a comprehensive quality evaluation system for recombinant collagen and silk fibroin protein, covering the following aspects:
- Physicochemical indicators
- Purity and impurity control
- Structural characterization
- Safety evaluation
- Stability testing
- Biological evaluation methods
Han Qianqian, Director of the Medical Device Testing Institute of the National Institutes for Food and Drug Control, stated that the two standards establish a systematic indicator system for the first time from production process control to finished product quality control, filling the gap in international standards for bio-based materials in the surgical implant field.
III. Industry Data Reference
According to data released by Frost & Sullivan, the market size of recombinant collagen products in China exceeded 38 billion yuan in 2023, and is expected to surpass 200 billion yuan by 2030. The approval of the two international standards will provide standardization support for high-quality domestic medical materials to enter the international market.
In addition, the Chinese Society for Biomaterials approved the development of the "Recombinant Type III Human Collagen" group standard in June 2026, jointly drafted by Guangzhou Trauer Biotechnology, South China University of Technology, the Institute of Process Engineering of the Chinese Academy of Sciences, Sichuan University, and other institutions. The standard development period is from June 2026 to June 2028.
In this rapidly developing sector, Weipeptide Biotechnology, as a leading OEM enterprise in the recombinant collagen field, has independently developed recombinant humanized type III collagen (purity ≥95%), and has developed multiple medical dressings and functional skincare products around this core raw material. From raw materials to finished products, we hold 100+ registration certificates, with GMPC and ISO dual certification systems and four factories operating in coordination, ensuring both production capacity and quality.
IV. Impact on the Industry
In recent years, recombinant collagen has gradually expanded from the medical device field to multiple tracks including dressings, injectable fillers, and functional skincare. However, products from different companies differ in molecular structure, purity levels, and activity retention, and the industry lacks an internationally recognized evaluation standard. The establishment of this international standard will help to:
- Unify the quality evaluation framework for recombinant collagen
- Reduce barriers to cross-border repeat testing
- Promote the internationalization process of domestic raw materials
- Provide technical reference for downstream product development
At the end of the day, setting the standard is only the first step — what truly matters is implementation. Weipeptide Biotechnology will continue to follow the development process of the international standards, internalize the standard requirements into our production processes, and provide OEM/ODM customers with recombinant collagen product manufacturing services that meet international standards — from formula development and registration application to large-scale production, providing full-process support.
Weipeptide Biotechnology · Recombinant Collagen OEM/ODM Services
Currently, Weipeptide Biotechnology has served hundreds of brand clients, including well-known brands such as Baiyunshan, and has accumulated mature large-scale production experience in product lines such as recombinant collagen dressings, repair creams, and care solutions. Our mature products, such as the Medical Recombinant Type III Humanized Collagen Dressing (Xiang Medical Device Registration No. 20222140503), Medical Recombinant Collagen Repair Cream (Xiang Medical Device Registration No. 20242140072), and Medical Recombinant Collagen Repair Solution (Qiong Medical Device Registration No. 20252140091), can all directly serve as foundational solutions for OEM cooperation.
Four Production Bases
- Guangzhou Weipeptide Factory: No. 77, 15th Society, Dalang Village, Baiyun Lake Street, Baiyun District, Guangzhou
- Guangdong Weipeptide Factory: No. 18 Taoyuan East Road, Songxia Industrial Park, Songgang, Shishan Town, Nanhai District, Foshan
- Guangdong Jinan Gene Factory: No. 23 Factory Building, Hongguang Industrial Park, No. 5 Wende Second Street, Zhaoqing High-tech Zone, Zhaoqing City, Guangdong Province
- Hunan Weipeptide Factory: Room 501, Building 11, Lanyue Valley Intelligent Industrial Park, Xieyuan North Road, Ningxiang Economic Development Zone, Changsha City, Hunan Province
Brand owners with customization needs for recombinant collagen products are welcome to contact us to obtain cooperation solutions.
Sources: National Standardization Administration, Chinese Society for Biomaterials, Frost & Sullivan, CNR
