Yes, biocompatibility testing is often required as part of the NMPA (National Medical Products Administration) certification process for medical devices in China. Biocompatibility testing assesses how compatible a device's materials are with biological systems, ensuring they do not cause harm or adverse reactions when used in patients. The specific requirements for biocompatibility testing depend on the classification and intended use of the medical device. Common tests include:

1. Biological Evaluation Plan: Manufacturers must provide a comprehensive biological evaluation plan that outlines the testing strategy based on the device's materials, intended use, and contact duration with the body.

2. ISO 10993 Standards: Testing typically follows the guidelines set by ISO 10993, a series of international standards for evaluating the biological safety of medical devices. These standards cover various aspects such as cytotoxicity, sensitization, irritation, and systemic toxicity.

3. Testing Protocols: Specific tests may include cytotoxicity testing, sensitization testing, irritation or intracutaneous reactivity testing, systemic toxicity testing, genotoxicity testing, and implantation testing, among others.

4. Clinical Use Considerations: Devices intended for prolonged or permanent contact with the body, such as implants, may require more extensive testing to ensure safety over the device's intended lifetime.

Biocompatibility testing is critical to demonstrate the safety of medical devices and is an important component of regulatory submissions to the NMPA in China. It ensures that devices entering the market do not pose undue risks to patients or users due to their biological interaction.

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