The NMPA released the “Review Key Points of Recombinant Human Collagen Injection Materials for Plastic Surgery (Draft)” on December 29, 2022, directing manufacturers on type test, preclinical testing, clinical evaluation, and regulatory submission.
Recombinant Human Collagen is a Class III device. The division of registration units should focus on factors such as the technical principle, structural composition, performance indicators and scope of application, based on “Guideline on Division of Medical Device Registration Units”:
- Different types of recombinant humanized collagen.
- Different recombinant humanized collagen amino acid sequences.
- Different injection material dosage forms, such as solution, lyophilized powder, gel, etc.
When the material characteristics such as collagen structure are different, resulting in large differences in product performance indicators, it is recommended to divide them into different registration units.
Other Highlights of the NMPA Recombinant Human Collagen Guideline
- The English name of the imported product should be consistent with the that of country of origin.
- For raw materials that are expected to come into contact with the human body, if raw materials are purchased, the supplier of raw materials and quality standards and test reports should be provided to NMPA
- The type, gene sequence and structural characteristics of recombinant human collagen shall be described in detail.
- According to YY/T 0316 “Medical Device Risk Management Application to 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.
- The registration applicant needs to develop relevant testing methods to ensure that the items in the product technical requirements are tested with finished products, and if the prior art cannot test the item on the finished product, it will provide research materials using intermediate or raw materials to carry out the project, and at the same time need to demonstrate that other alternative items in the product technical requirements support the relevant functionality or safety.
- The inspection method of the product needs to be set according to the technical performance indicators, and the inspection method should give priority to the methods in the national standard/industry standard. For clauses that are not applicable in the relevant national standards/industry standards, the reasons for the non-application need to be explained. All referenced standards are indicated with their number, year or version number. Self-built inspection methods can be explained in the form of product technical requirements appendix.
- Self-built inspection methods can be explained in the form of product technical requirements appendix.
- The model specifications must be of typical products that are representative in this registered unit.
- For self-built methods, it is necessary to provide corresponding basis, theoretical basis and methodological verification data, and ensure that the inspection methods are operable and reproducible.
- For materials or components first applied to recombinant humanized collagen injection for plastic surgery and cosmetology, submit relevant toxicological data analysis, clinical application history in relevant medical devices and other safety evaluation materials.
- Study the degradation and metabolism mechanism and characteristics of humanized collagen, provide research data on the degradation cycle of products in vivo, and provide supporting data on the metabolism of products and their degradation products in vivo.
- Identify hazards, exposure doses, etc. in materials/additives/processing aids and other potential leachables, and map the flow chart of biological evaluation based on risk management
- Biocompatibility risks include, but are not limited to: cytotoxicity, delayed hypersensitivity, intradermal reactions, genotoxicity, subcutaneous implantation reactions, acute systemic toxicity, subchronic toxicity, material-mediated pyrogenicity
- Biosafety study shall mainly focuse on immunogenicity safety: immunotoxicological evaluation and immunogen control and immunochemical testing.