Absorbable Hemostatic Product and other 11 Medical Devices Registration Review Guidelines issued by China's CMDE

Absorbable hemostatic product and other 11 medical devices registration review guidelines have been revised and published by the Center for Medical Device Evaluation (CMDE) on August 12, 2024. These guidelines are:

1. Hydrogel dressing registration review guidelines
2. Dialysis fluid filter registration review guidelines
3. Single-use sterile side hole blunt needles registration review guidelines
4. Single-use intravenous needles registration review guidelines
5. Safety and efficacy of medical devices applying nanomaterials part III biocompatibility toxicology evaluation registration review guidelines
6. α-Cyanoacrylate medical adhesives registration review guidelines (2024 revision)
7. Absorbable anti-adhesion products for abdominal and pelvic surgery registration review guidelines (2024 revision)
8. Absorbable Surgical Sutures registration review guidelines (revision 2024)
9. Absorbable Hemostatic Products registration review guidelines (2024 revision)
10. Single-Use Membrane Oxygenator registration review guidelines (for CPB) (revision 2024)
11. Single-Use Hydrocephalus Shunts registration review guidelines (2024 revision)
12. Single-Use Hemodialysis Tubing registration review guidelines (2024 revision)

These updates are crucial for manufacturers aiming to navigate the regulatory landscape in China. In this article, we will explore the key highlights from these newly revised guidelines, particularly focusing on α-cyanoacrylate medical adhesives, absorbable anti-adhesion products, absorbable surgical sutures and absorbable hemostatic products.

Absorbable Hemostatic Product Registration Review Guidelines

Absorbable hemostatic products are typically used during surgeries when conventional hemostatic techniques are ineffective, and they are absorbed by the body over time. Common materials include oxidized cellulose, gelatin, collagen, and plant-based polysaccharides. This guideline does not cover devices that control bleeding from vascular anastomoses, temporary vascular closures, or hemostatic devices containing thrombin or pharmaceuticals.

Key regulatory considerations:

• Regulatory Information: Accurate documentation is crucial, including the product application form, communication records, and authorization letters. Products should be classified following the Guiding Principles for the Division of Medical Device Registration Unit, with different materials and traits grouped into distinct registration units.
• Product Overview: The product's category, classification code, and name mustalign with China’s Medical Device Classification Catalog. These devices fall under Class III medical devices and must comply with the Naming Rules for Common Names of Medical Devices.
• Detailed Product Description: A comprehensive description must include the product’s properties, composition, dimensions, raw materials, intended use, and mechanism of action. Performance indicators and degradation characteristics are also required, along with comparison tables for different models and specifications.
• Non-Clinical and Clinical Data: Risk management information as per GB/T42062 must be provided. Clinical evaluation data should follow the Technical Guidelines for Clinical Trial Design of Medical Devices. If clinical trials are conducted, the data should follow the Code for Quality Management of Clinical Trials of Medical Devices.

α-Cyanoacrylate Medical Adhesives Registration Review Guidelines

α-Cyanoacrylate adhesives are composed of α-cyanoacrylate n-butyl ester, α-cyanoacrylate n-octyl ester, or similar esters, and may include excipients and associated application tools.

Key Regulatory Considerations:

• Product Name and Classification: The product name must follow the Naming Rules for Medical Device Common Names, describing its main components and use (e.g., "α-cyanoacrylate isobutyl medical adhesive"). These adhesives are categorized as Class III medical devices under "Adhesives" and "Cardiovascular Embolization Devices" in the Medical Device Classification Catalog.
• Registration Unit: Registration should follow the Administrative Measures for the Registration and Filing of Medical Devices, considering factors like the adhesive’s technical principle, structure, and performance. Different compositions or applications should be registered as distinct units.
• Product Specifications and Labeling: In accordance with the Medical Device Specifications and Labeling Regulations, the product labeling must include the composition, properties, and intended use of the adhesive. The labeling should also cover the sterilization method, expiration date, application instructions, and technical specifications.
• Usage Instructions: Detailed instructions should guide healthcare professionals on proper application methods, such as spot bonding or ultra-thin spraying, and strict dosage control. Clear warnings must be provided for contraindications, including use on infected or mucosal areas, or in patients allergic to cyanoacrylates. Precautions for accidental adhesive flows, particularly near the eyes, must be included.
• Risk Management and Adverse Events: A comprehensive risk management plan is essential, addressing potential issues like tissue necrosis, allergic reactions, and ectopic embolization. Specific warnings regarding acute inflammatory responses and prevention strategies for accidental adhesions are also required.

Absorbable Anti-adhesion Products for Abdominal and Pelvic Surgery Registration Review Guidelines

These products fall under Class III medical devices in the Medical Devices Classification Catalog and include different formulations, such as films, gels, and solutions.

Key Considerations for Registration:

• Product Overview: The product name should comply with the Naming Rules for Common Names of Medical Devices. It should include a detailed description of the product’s properties (e.g., film, gel, solution), composition, and performance indicators. Any devices used alongside the product must also be described, including their materials, size, and intended use.
• Product Models and Specifications: Differences between product models and specifications must be clearly explained, using comparison tables and graphical illustrations to highlight differences in structure, function, and performance.
• Packaging Instructions: The packaging materials, including sterile barrier systems, should be clearly described. This section should also provide detailed packaging levels and specify materials used for sterilization and packaging integrity.
• Reference and Comparison to Similar Products: Information on similar products marketed domestically and internationally should be provided, along with details on the product’s research and development history. A comparison of the declared product with similar or predecessor products must be included, highlighting differences in structural composition, materials, performance, and intended use.
• Scope of Application and Contraindications: The product’s specific application, expected use in medical institutions, target patient population, and contraindications should be clearly stated. The product is intended for one-time use, and its safety and effectiveness must be supported by clinical validation.
• Risk Management: A comprehensive risk management report must cover all aspects of the product’s lifecycle, from raw materials and manufacturing to packaging, sterilization, and storage.

Absorbable Surgical Sutures Registration Review Guidelines

These sutures are made from mammalian collagen or synthetic polymers like polyglycolic acid (PGA) and poly(p-dioxane) (PPDO) and are intended for use in human tissue suturing and ligation. The guidelines do not cover facial implants, facelift sutures, non-absorbable sutures, or sutures used for osseointegration.

Key Regulatory Requirements:

• Product Classification and Naming: Absorbable sutures are classified as Class III medical devices under classification code 02-13-06. The product name must adhere to the Naming Rules for Common Names of Medical Devices and be consistent with international naming conventions, such as "Absorbable Surgical Suture" or "Synthetic Absorbable Suture."
• Product Performance Requirements: Performance criteria include physical and chemical properties, as outlined in standards like YY 1116 for absorbable surgical sutures. Special designs, such as barbed sutures, must have additional performance parameters like barbed depth and angle. Sutures with attached needles must meet the requirements of YY/T0043. Sterility and bacterial endotoxins should also be addressed in testing.
• Inspection Reports: Registration applicants must submit product inspection reports, either self-inspection reports compliant with the Medical Device Registration Self-Inspection Management Regulations or reports from qualified medical device inspection agencies.
• Clinical Evaluation: Since absorbable sutures are not exempt from clinical evaluation, applicants must provide clinical data following the Technical Guidelines for the Clinical Evaluation of Medical Devices.
• Product Instructions and Labeling: Detailed warnings and precautions must be included. For example, warnings like “Avoid prolonged exposure to urine or bile” should explain the risk of stone formation. Precautions should cover handling, such as avoiding damage to the suture during use, as this can impact its breaking strength or absorption rate.
• Adverse Events: Any adverse events associated with the use of the sutures must be reported, with a separate list provided detailing observed adverse events for each type of suture.

Further information

With the newly revised guidelines, manufacturers must carefully review their current processes to ensure compliance with the updated standards. The revisions emphasize greater specificity in product descriptions, enhanced risk management, and stricter clinical evaluation processes across all device categories. Companies planning to introduce or renew medical devices in the Chinese market should begin preparing now for these new requirements.

For a more in-depth look, you can read the original CMDE announcement on Absorbable Hemostatic Product and other 11 Medical Devices Registration Review Guidelines.

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