The certification of Traditional Chinese Medicine (TCM) devices by the National Medical Products Administration (NMPA) in China involves a specialized regulatory framework. TCM devices encompass a wide variety of medical products, including acupuncture needles, cupping devices, therapeutic instruments (like TENS units), and more. These products are subject to specific standards and regulations that differ from those for Western medical devices, although there is overlap in some technical and safety requirements.

Below is a detailed overview of the regulations and technical requirements for Traditional Chinese Medicine (TCM) devices certified by NMPA.

1. Regulatory Framework for TCM Devices in China

A. Classification of TCM Devices

• Medical Device Classification: TCM devices are classified under the general framework for medical devices in China. They can be classified into:

  • Class I: Low-risk devices that do not require clinical trials (e.g., acupuncture needles, some therapeutic instruments).
  • Class II: Medium-risk devices that require a more detailed review (e.g., cupping devices, TCM diagnostic devices).
  • Class III: High-risk devices that require more extensive clinical data and rigorous testing (e.g., TCM devices that incorporate electrical stimulation or more complex technologies).

  The NMPA’s Regulation on the Classification of Medical Devices (GB 2260-2018) provides guidelines on how to classify devices, including TCM devices, based on their intended use and risk profile.

B. Registration and Certification Requirements

• NMPA Registration: TCM devices must be registered with the NMPA to be legally sold in China. Registration requires submission of a registration dossier with detailed technical documentation demonstrating compliance with Chinese standards.
• Local Authorized Representative: Foreign manufacturers must appoint a local authorized representative (LAR) in China for NMPA registration purposes.
• Clinical Trial Requirements: While many TCM devices, especially lower-risk ones, may not require clinical trials, certain Class II and Class III devices may need to undergo clinical trials to prove safety and efficacy in accordance with NMPA requirements.
• Manufacturing Site Inspection: NMPA may require an on-site inspection of the manufacturing facility, especially for foreign manufacturers, to ensure compliance with Good Manufacturing Practices (GMP) for medical devices.

C. Specific TCM Device Guidelines

• TCM Device Specific Standards: There are certain Chinese National Standards (GB) and Industry Standards (YY) specifically tailored for TCM devices. These standards address aspects such as:
  • Safety: Electrical safety for electrical-based TCM devices (e.g., therapeutic devices using electrical stimulation).
  • Biocompatibility: Requirements for testing the biocompatibility of materials used in TCM devices, such as acupuncture needles.
  • Performance: Standards for the performance characteristics of devices, including efficacy claims, accuracy, and reliability (e.g., TCM diagnostic equipment like infrared thermometers or electrical stimulation units).

2. Key Technical Requirements for TCM Devices

A. Safety Requirements

• Electrical Safety (for Electrical TCM Devices): For electrical devices such as electroacupuncture stimulators or TENS units, compliance with GB 9706 (medical electrical equipment) is required. This standard covers:

  • Electrical shock protection.
  • Electromagnetic compatibility (EMC) to prevent interference with other medical devices or electronics.
  • Leakage current testing.
  • Insulation resistance and dielectric strength testing.

• Biocompatibility Testing: TCM devices, especially those with direct contact with the human body (such as acupuncture needles, cupping devices, and herbal poultice tools), must undergo biocompatibility testing according to ISO 10993 or equivalent Chinese standards (e.g., YY/T 0466 for acupuncture needles). Tests may include:

  • Cytotoxicity testing.
  • Skin irritation and sensitization tests.
  • Hemocompatibility testing (especially for devices that come into contact with blood).

• Sterility and Sterilization: For single-use devices, such as acupuncture needles, the manufacturer must provide evidence of sterilization processes that comply with relevant Chinese standards (e.g., GB/T 14233 for sterilization of medical devices).

B. Performance Requirements

• Accuracy and Reliability: Devices used for TCM diagnostic purposes, such as electromagnetic therapy devices or diagnostic instruments, must meet the accuracy and reliability standards specified in Chinese medical device standards.
  • Performance tests, such as measuring accuracy for diagnostic devices or stimulus intensity for electroacupuncture devices, are common.
• Material Safety: The materials used in TCM devices (especially those in direct contact with patients, such as needles, cups, or herbal tools) must comply with material safety standards:
  • Non-toxic, non-carcinogenic, and biocompatible materials are a must.
  • For acupuncture needles, the materials (usually stainless steel or similar) must pass corrosion resistance and durability tests.

C. Labeling and Packaging Requirements

• Chinese Labeling: All TCM devices must have labels in Chinese, with detailed information on:
  • Manufacturer and importer details.
  • Device name, model, and intended use.
  • Usage instructions, contraindications, and safety precautions.
  • Regulatory approvals (e.g., NMPA registration number).
• Packaging Standards: TCM devices must meet Chinese packaging requirements, ensuring that the packaging protects the device during transportation and storage, is tamper-proof, and includes expiration dates where applicable.

3. Clinical Trial Requirements (for Certain TCM Devices)

Certain Class II and III TCM devices (especially those that incorporate new technologies or are intended for complex treatments) may require clinical trials to prove safety and efficacy in Chinese patients.

A. Clinical Trial Application (CTA) Process

• Clinical Trial Application (CTA): Manufacturers must submit a CTA to NMPA before starting clinical trials. The CTA must include:
  • Study protocols.
  • Informed consent documents.
  • Ethics committee approval.
  • Investigation sites (must be NMPA-approved).
• Conducting Trials: Clinical trials should follow Chinese Good Clinical Practice (GCP) guidelines, which are similar to international GCP standards but have additional requirements specific to China.

B. Clinical Data Submission

• Once clinical trials are completed, the results must be submitted as part of the registration dossier for NMPA review. This includes efficacy data (demonstrating how well the device works) and safety data (demonstrating that it does not cause harm to patients).

4. Post-Market Surveillance and Obligations

After receiving NMPA certification, manufacturers must continue to adhere to several post-market obligations, particularly in the case of higher-risk TCM devices.

A. Adverse Event Reporting

• Manufacturers are required to monitor the performance of the TCM device after it enters the market and report any adverse events or malfunctions to NMPA within a specified timeframe (e.g., within 10 days for serious incidents).

B. Post-Market Surveillance

• TCM devices, like all medical devices in China, are subject to ongoing post-market surveillance. Manufacturers must establish a system for collecting feedback from users, analyzing product performance, and submitting annual or biennial reports to NMPA.

5. Key Challenges in NMPA Certification for TCM Devices

• Diverse Regulatory Landscape: The regulatory landscape for TCM devices is more varied compared to Western medical devices due to the broad range of products in this category.
• Lack of Precedents: For many new or innovative TCM devices (especially those involving new technologies), the absence of clear precedents can complicate the approval process. Manufacturers may need to engage with NMPA directly to navigate such issues.
• Clinical Data Requirements: Gathering clinical data for TCM devices, especially those with historical or traditional uses, may be challenging, as NMPA may require modern clinical evidence in line with international standards.

Conclusion

The NMPA certification process for Traditional Chinese Medicine (TCM) devices in China is governed by a detailed regulatory framework, which emphasizes safety, performance, and compliance with local standards. While many TCM devices may have less stringent requirements (e.g., acupuncture needles), those incorporating modern technology or innovative uses may face more rigorous scrutiny, including clinical trials and performance testing. Manufacturers must ensure that their products meet Chinese safety standards, engage with local representatives, and prepare for a thorough and potentially lengthy registration process with the NMPA.