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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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