NMPA issued "Guideline on Recombinant Humanized Collagen Raw Materials" and "Guideline on Recombinant Collagen Wound Dressings" on May 23, 2023. The two guidelines are final versions after the drafts for feedback released in late 2022.
NMPA Collagen Guideline on Recombinant Humanized Collagen Raw Materials
The 54-page collagen raw materials guideline elaborates the four key points for registration review in China:
- Material performance study
- Material Immunological safety
- Biological risks
- Stability and direct contact container study
Highlights of the guideline include:
- The type, gene sequence and structural characteristics of recombinant human collagen shall be described in detail.
- According to GB/T 42062 "Risk Management Application for Medical Devices", risk analysis is carried out from biological hazards, environmental hazards, hazards related to use, hazards caused by functional failure, maintenance, etc. for raw materials, production and processing processes, product packaging, sterilization, transportation, storage, and use.
- For the finished products, the registration applicant needs to develop relevant testing methods to ensure that the main technical indicators for testing shall comply with product technical requirements (PTRs), If there are other indicators, it is recommended that the registration applicant formulate them in combination with applicable standards such as YY/T 1627, product design features and clinical applications. Registration applicants shall provide the rationale if they do not adopt the clauses (including national standards and industry standard requirements).
- For materials or components first applied to recombinant humanized collagen injection for plastic surgery and cosmetology, registrants shall submit relevant toxicological data analysis, clinical application history in relevant medical devices and other safety evaluation materials.
- Biocompatibility risks include, but are not limited to cytotoxicity, delayed hypersensitivity, intradermal reactions, genotoxicity, subcutaneous implantation reactions, acute systemic toxicity, sub-chronic toxicity, material-mediated pyrogenicity.
- Biosafety study shall mainly focus on immunogenicity safety: immunotoxicology evaluation and immunogen control and immunochemical testing.
Guideline on Recombinant Collagen Wound Dressings
The document confirms that the collagen wound dressings are Class II devices. When classified into subcategories of -01 wound dressing, -04 gel dressing and -08 liquid, paste dressing, they can be exempted from clinical trial.
If you have any questions about these two guidelines, please email me at gpalma@ChinaMedDevice.com
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Grace Fu Palma
ChinaMed Device, LLC
MA, U.S.
gpalma@ChinaMedDevice.com
978-390-4453
www.ChinaMedDevice.com
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