CMDE Releases Draft Guidance for Registration Review of Recombinant Collagen Products for Plastic and Aesthetic Use

On October 21, 2026, the Center for Medical Device Evaluation of the National Medical Products Administration released the draft “Guidance for Registration Review of Recombinant Collagen Products for Plastic and Aesthetic Use” for public comment. The comment period closes on November 15, 2026. The document is intended to guide applicants in preparing and drafting registration dossiers for plastic and aesthetic recombinant collagen products and to provide a reference for technical review.

The draft applies to plastic and aesthetic recombinant collagen products that use recombinant collagen or cross-linked recombinant collagen as the sole active ingredient. The scope described in the document includes facial dermal tissue filling to correct dynamic forehead wrinkles, correction of midface volume loss and/or midface contour defects, and intradermal injection filling of the neck to correct moderate-to-severe neck wrinkles, with the specific scope to be determined based on product design, performance characteristics, and clinical evidence. It does not apply to products whose formulation contains other active ingredients in addition to recombinant collagen materials, such as sodium hyaluronate. Products containing multiple active ingredients, as well as recombinant collagen products using new materials, new designs, or new processes, may refer to applicable parts of the draft based on product characteristics. Products injected into the dermis and/or subcutaneous tissue to fill and increase tissue volume are Class III medical devices under classification code 13-09-02.

The review considerations cover regulatory information, summary information, non-clinical information, clinical evaluation information, instructions for use and labels, and quality management system documents. The non-clinical section focuses on product risk management, performance studies, biological characteristics, safety of biological-source materials, immunotoxicology, sterilization processes, animal studies, and stability studies. Performance studies include quality control of recombinant collagen materials, material selection and formulation design, heterogeneity analysis, cross-linking-related studies, in vitro cell interaction, degradation and metabolism, higher-order structure, reconstitution, dose/frequency, and combination-use studies. For clinical evaluation, the recommended pathway for these products is clinical trials. The instructions for use and labels should specify the scope of application, method of use, contraindications, complications, and identification and emergency management of embolism.

Comments and suggestions should be submitted to CMDE by November 15, 2026, in accordance with the notice.