The regulation and technical requirements for Traditional Chinese Medicine (TCM) devices certified by the National Medical Products Administration (NMPA) in China are detailed and specific, as they address both the unique nature of TCM treatments and the broader regulatory framework for medical devices in the country. Below are key aspects of the regulatory process and technical requirements:

1. Classification of TCM Devices

TCM devices are categorized based on their risk level, similar to other medical devices. The classification system divides devices into three classes:

• Class I: Low-risk devices subject to basic regulatory controls.
• Class II: Medium-risk devices requiring more detailed regulatory controls.
• Class III: High-risk devices subject to the strictest regulatory controls, including clinical trials and more comprehensive testing.

Most TCM devices are likely to fall under Class II or Class III due to their therapeutic claims and complexity.

2. Regulatory Process for TCM Devices

The process for obtaining NMPA approval for TCM devices follows several key steps:

• Pre-market Registration: Manufacturers must apply to NMPA for product registration before marketing TCM devices in China. This application must include:

  • Product name, model, and classification
  • Intended use and performance claims
  • Manufacturing processes
  • Risk analysis and mitigation measures

• Clinical Trials (if applicable): TCM devices classified as Class III or certain Class II devices may require clinical trials to demonstrate safety and effectiveness. These trials must follow NMPA guidelines, and data must be collected in Chinese clinical environments.

• Technical Requirements: The product must meet the relevant technical standards, such as the GB (Guobiao) Standards for medical devices. These standards cover aspects like safety, performance, and electromagnetic compatibility. Specific standards for TCM devices may address traditional treatment methods, materials, and device design.

• Technical Documentation: The manufacturer must provide comprehensive documentation, including:

  • Product Specifications: Detailing the components, operation, and usage of the device.
  • Safety and Performance Data: Including risk analysis and compliance with GB standards (e.g., electrical safety, mechanical safety).
  • Quality Management System (QMS) Compliance: TCM device manufacturers must operate under a QMS compliant with ISO 13485 or equivalent standards.

3. Testing Requirements

The NMPA requires extensive testing for TCM devices, including:

• Electrical and Mechanical Safety: For devices with electrical components, testing for electrical safety, EMC (Electromagnetic Compatibility), and performance must be conducted according to GB 9706 standards.
• Material Safety: Materials used in TCM devices (e.g., herbal extracts, metals, ceramics) must be tested for biocompatibility and toxicity.
• Therapeutic Efficacy: For devices making specific therapeutic claims, such as acupuncture or cupping devices, clinical evidence demonstrating effectiveness may be required. This evidence can include data from traditional Chinese clinical practices, but must be robust enough to meet NMPA standards.
• Microbiological Testing: If the device interacts with the body or is meant for multiple uses, microbiological safety testing is crucial.

4. Labeling and Packaging Requirements

The labeling and packaging for TCM devices must comply with the following:

• Product Labels: Must include the product name, usage instructions, warnings, manufacturing date, and expiration date. The labels must be in Chinese.
• Packaging: Packaging must protect the device during transportation and storage and may need to include specific symbols or statements related to the device’s TCM application (e.g., acupuncture needles, cupping sets).
• Manuals: User manuals should clearly outline the proper usage of the device, including contraindications, instructions for use, and cleaning/maintenance information.

5. Post-Market Surveillance

Once the device is on the market, manufacturers are required to implement post-market surveillance practices, including:

• Adverse Event Reporting: Manufacturers must report any adverse events or product defects to the NMPA.
• Periodic Inspections: Manufacturers must conduct periodic reviews of their device’s performance in the field to ensure ongoing safety and compliance.

6. Special Considerations for TCM Devices

Given the traditional nature of many TCM therapies, certain devices may not fit neatly into the traditional medical device categories. For example:

• Herbal medicine devices: If a device is used to prepare or apply herbal medicines, such as an electric herb grinder, it may need to meet additional regulations regarding the materials used.
• Acupuncture and Moxibustion Devices: For devices like acupuncture needles or moxibustion tools, manufacturers need to show they meet specific safety and material standards, as well as efficacy evidence.
• Cupping Devices: For cupping devices, there must be assurance of their mechanical safety, hygiene, and therapeutic claims.

7. Certifications and Standards

• ISO 13485 Certification: While not mandatory for all devices, manufacturers often need ISO 13485 certification for quality management systems to be eligible for NMPA registration.
• Good Manufacturing Practice (GMP): Facilities producing TCM devices must adhere to GMP standards, ensuring consistent product quality and safety.

8. Local Representation

Foreign manufacturers must have a Chinese Agent (domestic company or representative) to facilitate the NMPA registration process. This agent will serve as a liaison between the foreign manufacturer and the NMPA.

Conclusion

The regulation and certification of TCM devices in China by the NMPA are based on a structured process aimed at ensuring safety, efficacy, and quality. TCM devices must meet the same rigorous standards as other medical devices but also adhere to specific requirements that reflect their traditional use and treatment methods. Manufacturers should be prepared for extensive documentation, testing, and potential clinical trials, particularly for higher-risk devices.