This guidance document is intended to assist registration applicants in preparing and drafting registration application materials for oral repair membranes, while also providing technical reference for the review of registration application materials by technical evaluation departments.

This guidance document outlines general requirements for the registration application materials of oral repair membranes. Applicants should determine the applicability of the content based on the specific characteristics of their product. If certain sections are not applicable, the applicant must provide a detailed explanation of the reasons and corresponding scientific justification, and supplement or refine the registration application materials according to the product's specific features.

This guidance document serves as a reference for registration applicants and technical reviewers. However, it does not cover administrative matters related to evaluation and approval, nor is it enforceable as a regulation. It must be used in compliance with relevant regulations and mandatory standards. If alternative methods that meet regulatory requirements are available, they may be adopted, but detailed research and validation data must be provided.

This guidance document is formulated based on current regulations, standards, and the existing level of scientific understanding. As regulations and standards evolve and technology advances, the content of this guidance document will be adjusted accordingly.

1. Scope of Application

The oral repair membranes covered in this guidance document are typically used in conjunction with oral bone-filling materials in dental implant procedures. They are intended for reconstructing alveolar bone tissue in the implant area of patients with missing teeth, addressing insufficient horizontal or vertical bone volume. These membranes prevent the infiltration of fibroblasts and epithelial cells from soft tissues while providing time and space for slower-proliferating osteoblasts to enter the bone defect area, thereby guiding bone/tissue regeneration.

Oral repair membranes can be classified by degradation properties into:

• Absorbable membranes (natural and synthetic polymer-based, such as collagen membranes, silk fibroin membranes, polylactic acid membranes)

• Non-absorbable membranes (e.g., polytetrafluoroethylene (PTFE) membranes, titanium membranes)

This guidance document primarily applies to naturally derived absorbable repair membranes. For non-absorbable membranes, absorbable metallic alloy membranes (e.g., magnesium-based, zinc-based), or synthetic polymer absorbable membranes (e.g., polylactic acid), relevant sections of this guidance may be referenced where applicable.

2. Key Points for Registration Review

(1) Regulatory Information

1. Product Name
The product name should follow national or industry standard nomenclature or be based on clinical intended use and application site, complying with regulations such as:

• General Naming Rules for Medical Devices

• Guidance on General Naming Principles for Dental Instruments

The name may include descriptors such as:

• Technical features: "Absorbable," "Repair," "Barrier"

• Material composition: "Collagen"

• Clinical application site: "Oral"
  Example: "Absorbable Collagen Oral Repair Membrane"

2. Classification Code
Based on the Medical Device Classification Directory, the product falls under:

• Management Category: Class III

• Subcategory: 17 – Dental Instruments

• Primary Category: 17-08 – Oral Implant and Tissue Reconstruction Materials

• Secondary Category: 17-08-06 – Bone Filling and Repair Materials

3. Principles for Registration Unit Division
The division of registration units must comply with the Guidance on the Division of Medical Device Registration Units. Generally, registration units are divided based on:

• Technical principles

• Structural composition

• Performance indicators

• Intended use

Different registration units are required in the following cases:

• Different raw material compositions (e.g., collagen vs. silk fibroin)

• Different biological sources (e.g., porcine pericardium vs. bovine pericardium vs. silkworm cocoon-derived)

• Different tissue sources from the same species (e.g., bovine pericardium vs. bovine Achilles tendon)

• Different preparation processes (e.g., decellularized vs. collagen-extracted)

Same registration unit applies if:

• The biological source, tissue origin, and processing method are identical (e.g., decellularized porcine small intestinal submucosa collagen membranes with different sizes or designs).

4. Product List
Clearly define the model/specification naming convention and the division principles. For products with multiple models/specifications, specify the differences between them. Use comparison tables or annotated diagrams to describe:

• Structural composition

• Function

• Product features

• Technical parameters