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The Medical Device Master File is a form of technical documentation submitted by its owner to the medical device technical review authority. It is used to authorize medical device registration applicants to reference it as part of their registration submission materials when applying for medical device registration. As a raw material for medical device products, recombinant collagen is eligible for master file registration.
Recombinant collagen, as a raw material of medical devices, is primarily used in the following areas:
1) Application as a passive implant, registered as a Class III medical device;
2) Application as a hemostatic and anti-adhesion material:
If the product is partially or fully absorbable by the human body or intended for internal use, it is regulated as a Class III medical device; If the product is non-absorbable and intended solely for external use, it is regulated as a Class II medical device;
3) Application as a medical wound dressing:
If the product is partially or fully absorbable by the human body or intended for chronic wounds, it is regulated as a Class III medical device; If the product is non-absorbable and intended for non-chronic wounds, it is regulated as a Class II medical device.
1. Technological process
Recombinant collagen is a technology that involves specific sequence design, restriction enzyme digestion and splicing, and vector insertion of human collagen genes, followed by transfer into host cells (including microorganisms, animals, and plants) for fermentation-induced expression to produce collagen or its analogues. The production process of recombinant collagen primarily includes the construction of expression systems, fermentation, and purification. For animal-derived recombinant collagen, the research documentation must additionally include technical data related to controlling the risks of viral and/or infectious agent contamination as well as immunogenicity.
2. Reference indicators
Technical documentation for medical device raw materials (excluding in vitro diagnostic reagents) generally refers to the description of raw material composition, research data on physicochemical properties, biological evaluation data, toxicological risk analysis data, etc. For recombinant collagen, the following indicators may be referenced for testing:
1) Physicochemical Properties
Appearance, visible particles, solubility, moisture and residue on ignition, pH, osmolality, dynamic viscosity, thermal stability, and fill volume and its variation.
2) Identification
Peptide mapping, terminal amino acid sequence, molecular weight, and isoelectric point.
3) Purity
Testing can be conducted using electrophoresis or high-performance liquid chromatography (HPLC).
4) Impurities, Contaminants, and Additives
Impurity testing may involve items such as residual exogenous DNA, residual E. coli proteins, residual yeast proteins, residual CHO host cell proteins (HCP), residual antibiotic content/activity, pro-inflammatory contaminants (e.g., peptidoglycan), heavy metal and trace element content, and additives.
5) Content
Can be calculated based on total protein content and purity.
6) Structural Characterization
Studies can include specificity analysis, primary structure characterization, infrared spectroscopy (IR), circular dichroism spectroscopy (CD), micro-differential thermal analysis (micro-DTA), protease sensitivity analysis, proline hydroxylation analysis, and glycosylation modification analysis.
7) Biological function:
The main biological function of recombinant collagen is to provide a scaffold and a favorable microenvironment for cells. The biological function of recombinant collagen can be evaluated by assessing the cell-collagen interaction, such as cell proliferation, cell differentiation, cell adhesion, cell migration or transmigration.
8) Safety Testing
Sterility, bacterial endotoxins, microbial limits, etc.
9) Biological evaluation:
As a raw material for manufacturing medical device products, recombinant collagen shall undergo necessary biological evaluation in accordance with the requirements of GB/T 16886.1. For recombinant protein products designed based on partial human collagen nucleic acid sequences, if immunogenicity risks cannot be excluded, immunology studies should be additionally considered.
10) Packaging, transportation, and storage:
When manufacturers supply raw materials for medical device research and development, they should provide necessary information and it is recommended that they consider the requirements of relevant medical device products for packaging, storage and transportation of raw materials.
3. Registered recombinant collagen (as of July 31, 2025)
No. | Owner Name | Master File Registration Item | Master File Registration Number | Registration /Update Date |
1 | Shanxi Jinbo Bio-Pharmaceutical Co.,Ltd. | Implant-grade Recombinant Humanized Type III Collagen | M2021001-001 | 2022/10/31 |
3 | Jiangsu Trautec Medical Technology Co., Ltd. | Recombinant Type III Humanized Collagen Raw Materials | M2021003-001 | 2023/12/8 |
18 | Jiangsu Jland Biotech Co., Ltd. | Recombinant Type III Humanized Collagen Raw Materials | M2021018-001 | 2021/12/24 |
110 | Shanxi Jinbo Bio-Pharmaceutical Co., Ltd. | Recombinant Type III Humanized Collagen Lyophilized Fiber | M2022077-001 | 2022/10/31 |
121 | Xi'an Denovo Hith Medical Technology Co., Ltd. | Recombinant Type III Humanized Collagen Raw Materials | M2022089-000 | 2022/10/31 |
122 | Guangxi Fulaiming Biopharma Co., Ltd. | Recombinant Humanized Type I Collagen Solution | M2022090-000 | 2022/10/31 |
145 | Guangzhou Tyran Biotech Co., LTD. | Recombinant Type III Humanized Collagen Raw Materials | M2023005-000 | 2023/1/4 |
186 | Wuhu Interferon Bio-products Industry Research Institute Co., Ltd. | Recombinant Type III Humanized Collagen Raw Materials | M2023046-000 | 2023/4/21 |
225 | Shanxi Jinbo Bio-Pharmaceutical Co.,Ltd. | Recombinant Humanized Type III Collagen Low-Temperature Gel for Injection | M2023085-000 | 2023/8/14 |
228 | Nitta Gelatin Inc. | beMatrix Collagen | M2023088-000 | 2023/8/14 |
280 | Xi'an Denovo Hith Medical Technology Co., Ltd. | Implant-grade Recombinant Type III Humanized Collagen Raw Materials | M2023140-000 | 2023/11/14 |
283 | Wuhu Interferon Bio-products Industry Research Institute Co., Ltd. | Recombinant Humanized Collagen | M2023143-000 | 2023/12/8 |
314 | Guangzhou Sybetter Medical Co., Ltd. | Medical Bioactive Bovine Type I Collagen Raw Material | M2023174-000 | 2023/12/26 |
316 | Biopharmaceutical Research & Development Center of Guangzhou JiNan University | Recombinant Collagen Raw Material | M2023176-001 | 2024/3/15 |
373 | Guangxi Fulaiming Biopharma Co., Ltd. | Recombinant Humanized Type I Collagen | M2024043-000 | 2024/2/6 |
382 | JHM Biopharm (Tonghua) Co., Ltd. | Recombinant Type III Humanized Collagen Raw Materials | M2024052-000 | 2024/2/6 |
387 | Zhejiang Zhuji Jland Biotech Co., Ltd. | Recombinant Type III Humanized Collagen Raw Materials | M2024057-002 | 2025/2/11 |
393 | Nanjing Do-Won Biotech Co., Ltd. | Recombinant Human Type I Collagen Raw Material - DW-001 | M2024063-000 | 2024/3/15 |
416 | Jiangsu Gproan Biotech Co., Ltd. | Recombinant Type III Humanized Collagen Raw Materials | M2024086-000 | 2024/3/15 |
422 | Jiangsu Yaohai Novagen Biotech Co., Ltd. | Recombinant Type III Humanized Collagen Raw Materials | M2024092-001 | 2024/10/16 |
426 | Guangxi Fulaiming Biopharma Co., Ltd. | Fuhuo Factor (FHTFF) -Recombinant Type I Humanized Collagen (Type B) Raw Material | M2024096-000 | 2024/4/11 |
433 | Jiangsu Gensun Biomaterials Co., Ltd. | Recombinant Type III Humanized Collagen | M2024103-000 | 2024/4/11 |
434 | Jiangsu Gensun Biomaterials Co., Ltd. | Modified Recombinant Humanized Type III Collagen | M2024104-000 | 2024/4/11 |
448 | Biopharmaceutical Research & Development Center of Guangzhou JiNan University | Recombinant Type XVII Humanized Collagen Raw Materials | M2024118-000 | 2024/4/11 |
458 | Xi'an Denovo Hith Medical Technology Co., Ltd. | Recombinant Type IV Humanized Collagen Raw Materials | M2024128-000 | 2024/5/11 |
494 | Zhejiang Zhuji Jland Biotech Co., Ltd. | Recombinant Type I Humanized Collagen Raw Materials | M2024164-000 | 2024/6/8 |
514 | Hebei Nacol Biotech Co., Ltd. | Recombinant Type III Humanized Collagen | M2024184-000 | 2024/6/8 |
520 | Bloomage Biotech Co., Ltd. | Recombinant Type III Humanized Collagen Raw Materials | M2024190-000 | 2024/6/8 |
533 | Shanghai Semelife Cell Technology Co., Ltd. | CEFFE-X01 Recombinant Collagen | M2024203-000 | 2024/7/16 |
537 | Lanzhou Biotech Development Co., LTD | Recombinant Collagen Raw Materials | M2024207-000 | 2024/7/16 |
539 | Guangxi Fulaiming Biopharma Co., Ltd. | Recombinant Collagen | M2024209-000 | 2024/7/16 |
588 | Nanjing Cellnuo Biotech Co., Ltd. | Recombinant Type III Humanized Collagen Raw Materials | M2024258-000 | 2024/8/10 |
598 | Jiangsu Hernrrie Biomedical Technology Co., Ltd. | Recombinant Type III Humanized Collagen Raw Materials | M2024268-000 | 2024/8/10 |
600 | Qinhuangdao Zhiyuan Huabo Electronics Co., Ltd. | Recombinant Type III Humanized Collagen Raw Materials | M2024270-000 | 2024/8/10 |
606 | Shandong D-Nutrimec Biomedical Co., Ltd. | Recombinant Type III Humanized Collagen | M2024276-000 | 2024/8/10 |
610 | Shenzhen Liying Biotech Co., Ltd. | Recombinant Humanized Type XVII Collagen | M2024280-000 | 2024/8/22 |
616 | Guangzhou Sybetter Medical Co., Ltd. | High-transparency Bioactive Porcine Type I Collagen | M2024286-000 | 2024/10/16 |
641 | Shenzhen Mellgen Biotech Co., Ltd. | Recombinant Type III Collagen Raw Materials | M2024311-000 | 2024/10/16 |
646 | Jilin Guoda Biomaterials Technology Co., Ltd. | Recombinant Type III Humanized Collagen Raw Materials | M2024316-000 | 2024/10/16 |
679 | Jiangsu Gproan Biotech Co., Ltd. | Recombinant Humanized Type XVII Collagen Raw Materials | M2024349-000 | 2024/10/16 |
683 | Shinya Biomedical (Huzhou) Co., Ltd. | Recombinant Type III Humanized Collagen Raw Materials | M2024353-000 | 2024/12/9 |
684 | Hantide Biomedical Group Co., Ltd. | Recombinant Humanized Type III Collagen Lyophilized Sponge Raw Material | M2024354-000 | 2024/12/9 |
705 | Shaanxi Witkang Biotech Co., Ltd. | Recombinant Collagen Lyophilized Sponge | M2024375-000 | 2024/12/9 |
712 | Zhejiang Bling Choice Biotech Co., Ltd. | Type I Collagen | M2024382-000 | 2024/12/9 |
727 | Shandong Freda Biological Co., Ltd. | Medical-grade Recombinant Type III Humanized Collagen Raw Materials | M2024397-000 | 2024/12/9 |
731 | Jiangsu Trautec Medical Technology Co., Ltd. | Recombinant Type XVII Collagen TTB01 Raw Material | M2024401-000 | 2024/12/9 |
763 | Guangdong Zhumei Biomedical Technology Co., Ltd. | Recombinant Type III Humanized Collagen Raw Materials | M2025006-000 | 2025/1/17 |
773 | Jilin Guoda Biomaterials Technology Co., Ltd. | Recombinant Type I Humanized Collagen Raw Materials | M2025016-000 | 2025/1/17 |
775 | Jilin Guoda Biomaterials Technology Co., Ltd. | Recombinant Type XVII Humanized Collagen Raw Materials | M2025018-000 | 2025/1/17 |
781 | Guangzhou Proyeslab Biotech Co., Ltd. | Recombinant Humanized Collagen Raw Materials | M2025024-000 | 2025/1/17 |
794 | Blame Pharmaceutical Co. Ltd. | Recombinant Humanized Type III Collagen Sponge | M2025037-000 | 2025/2/11 |
798 | Blame Pharmaceutical Co. Ltd. | Recombinant Collagen | M2025041-000 | 2025/2/11 |
803 | Guangdong Zhumei Biomedical Technology Co., Ltd. | Recombinant Humanized Type ⅩⅦ Collagen Raw Materials | M2025046-000 | 2025/2/11 |
804 | Guangdong Zhumei Biomedical Technology Co., Ltd. | Recombinant Type I Humanized Collagen Raw Materials | M2025047-000 | 2025/2/11 |
816 | Jiangsu Kamikiss Biotech Co., Ltd. | Recombinant Type III Humanized Collagen | M2025059-000 | 2025/3/18 |
827 | Jiangsu Gproan Biotech Co., Ltd. | Recombinant Type I Humanized Collagen Raw Materials | M2025070-000 | 2025/4/15 |
840 | Jiangsu Gproan Biotech Co., Ltd. | Recombinant Collagen Raw Materials | M2025083-000 | 2025/4/16 |
841 | Novoprotein (Heze) Technology Co., Ltd. | Recombinant Type XVII Humanized Collagen Raw Materials | M2025084-000 | 2025/4/16 |
843 | Novoprotein (Heze) Technology Co., Ltd. | Recombinant Type III Humanized Collagen Raw Materials | M2025086-000 | 2025/4/16 |
844 | Jiangsu Kamikiss Biotech Co., Ltd. | Recombinant Type III Humanized Collagen | M2025087-000 | 2025/4/16 |
880 | Jiangsu Kamikiss Biotech Co., Ltd. | Injectable-grade Recombinant Humanized Type III Collagen | M2025123-000 | 2025/4/16 |
889 | Zhuhai Gene Bioncon Biotech Co., Ltd. | Recombinant Type III Humanized Collagen Raw Materials | M2025132-000 | 2025/5/7 |
898 | Biohong Synthetic Biotech (Yantai) Co., Ltd. | Recombinant Type III Collagen (40 kDa) as Raw Material for Medical Devices | M2025141-000 | 2025/5/7 |
899 | Biohong Synthetic Biotech (Yantai) Co., Ltd. | Recombinant Type III Collagen (20 kDa) as Raw Material for Medical Devices | M2025142-000 | 2025/5/7 |
908 | Hangzhou Beilang Biotech Co., Ltd | Type I Collagen Solution for Injection | M2025151-000 | 2025/5/7 |
910 | Jiangsu Kamikiss Biotech Co., Ltd. | Medical-grade Recombinant Type XVⅡ Humanized Collagen | M2025153-000 | 2025/5/7 |
911 | Jiangsu Kamikiss Biotech Co., Ltd. | Injectable-grade Recombinant Type XVⅡ Humanized Collagen | M2025154-000 | 2025/5/7 |
917 | Novoprotein (Heze) Technology Co., Ltd. | Implant-grade Recombinant Type III Humanized Collagen Raw Materials | M2025160-000 | 2025/5/7 |
920 | Dongguan Everon Healthcare Biotech Co., Ltd. | Recombinant Human Type III Triple Helix Collagen | M2025163-000 | 2025/5/7 |
925 | Hainan Duoyuan Biotech Co., Ltd. | Type III Recombinant Human Collagen Raw Material - DY01 | M2025168-000 | 2025/5/29 |
926 | Hainan Duoyuan Biotech Co., Ltd. | Type II Recombinant Human Collagen - DY02 | M2025169-000 | 2025/5/29 |
927 | Hainan Duoyuan Biotech Co., Ltd. | Type Ⅲ Recombinant Human Collagen Raw Material - DY03 | M2025170-000 | 2025/5/29 |
932 | Hangzhou Mayliu Biotech Co., Ltd. | Recombinant Type III Humanized Collagen Raw Materials | M2025175-000 | 2025/5/29 |
946 | Tianjin Songguo Biomedical Technology Co., Ltd. | Type I Collagen Raw Material | M2025189-000 | 2025/5/29 |
947 | Blame Pharmaceutical Co. Ltd. | Recombinant Type III Humanized Collagen | M2025190-000 | 2025/5/29 |
952 | Jiangsu Kamikiss Biotech Co., Ltd. | Injectable-grade Recombinant Humanized Type I Collagen | M2025195-000 | 2025/5/29 |
953 | Jiangsu Kamikiss Biotech Co., Ltd. | Medical-grade Recombinant Humanized Type I Collagen | M2025196-000 | 2025/5/29 |
962 | Changzhou Timerein Biotech Co., Ltd. | Recombinant Type III Humanized Collagen Raw Materials | M2025205-000 | 2025/6/23 |
967 | Yuanpu (Tianjin) Biotech Co., Ltd. | Recombinant Type III Humanized Collagen | M2025210-000 | 2025/6/23 |
968 | Yuanyi (Tianjin) Biotech Co., Ltd. | Recombinant Type III Humanized Collagen | M2025211-000 | 2025/6/23 |
990 | Shenzhen Liying Biotech Co., Ltd. | Recombinant Humanized Type XVII Collagen Raw Material | M2025233-000 | 2025/7/11 |
993 | Shenzhen PAM²L Biotech Co., Ltd | Recombinant Type III Humanized Collagen | M2025236-000 | 2025/7/11 |
994 | Shenzhen PAM²L Biotech Co., Ltd | Recombinant Type ⅩⅦ Humanized Collagen | M2025237-000 | 2025/7/11 |
1001 | Shanghai Semelife Cell Technology Co., Ltd. | CEFFE-X01 Recombinant Collagen | M2025244-000 | 2025/7/11 |
1005 | Shenzhen Medgen Life Science Co., Ltd. | Type I Collagen for Injection Raw Material | M2025248-000 | 2025/7/11 |
1012 | Shaanxi Giant Biogene Biotech Co., Ltd. | Recombinant Type I Humanized Collagen Raw Materials | M2025255-000 | 2025/7/31 |
1017 | Shaanxi Guantu Biotech Co., Ltd. | Recombinant Humanized Type I & III Hybrid Collagen Raw Material | M2025260-000 | 2025/7/31 |
1019 | Jiangsu Trautec Medical Technology Co., Ltd. | Recombinant Type I Humanized Collagen Raw Materials | M2025262-000 | 2025/7/31 |
1022 | Gaoqing County, Zibo City, Shandong Province | Reconstituted Humanized Collagen Type XVII Lyophilized Sponge Raw Materials | M2025265-000 | 2025/7/31 |
1023 | Changzhou Institute of Materia Medica Co., Ltd. | Injectable-grade Recombinant Humanized Type XVII Collagen (Sterile Bulk Substance) | M2025266-000 | 2025/7/31 |
1026 | Beijing Baizhen Biotech Co., Ltd. | Recombinant Type III Humanized Collagen Raw Materials | M2025269-000 | 2025/7/31 |
1027 | Changzhou Timerein Biotech Co., Ltd. | Recombinant Type XVII Humanized Collagen Raw Materials | M2025270-000 | 2025/7/31 |
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