The background investigation of Traditional Chinese Medicine (TCM) device enterprises during the NMPA (National Medical Products Administration) certification process follows similar procedures to those for other medical device manufacturers. However, there are additional requirements and considerations specific to TCM devices due to their traditional, often non-invasive nature and the integration of herbal and natural components. Below are the key steps and standards for the background investigation of TCM device enterprises in the NMPA certification process:

1. Company Legal and Business Registration

• Business License: The enterprise must submit proof of legal registration in China, including the company’s business license, organization code, and tax registration.
• Local Representation: If the enterprise is foreign, it must appoint a local authorized agent or importer in China. This local entity will represent the manufacturer in dealings with NMPA and facilitate the regulatory process.

2. Manufacturing Capabilities and Compliance

• Good Manufacturing Practice (GMP): The NMPA requires TCM device manufacturers to meet Good Manufacturing Practice (GMP) for medical devices. The enterprise must have valid GMP certification, which ensures that the devices are manufactured under stringent quality standards.
• Facility Inspection: NMPA may conduct an on-site inspection of the manufacturing facilities to verify compliance with GMP and other safety standards. For foreign manufacturers, this inspection may be carried out by NMPA representatives or through accredited third-party inspections.
• Production Process Control: The enterprise must provide evidence of robust production process controls, including raw material sourcing, quality checks, and production traceability, particularly for TCM devices involving plant-based or herbal ingredients.

3. Quality Management System (QMS)

• ISO 13485 Certification: TCM device manufacturers are required to implement a Quality Management System (QMS) that meets ISO 13485 or equivalent standards. This system must be fully documented, with a focus on the consistent quality of products and regulatory compliance.
• Document Control: The QMS should include detailed procedures for document management, traceability, risk management, and product testing, particularly regarding the efficacy and safety of the TCM device.
• Post-Market Surveillance: The QMS must also demonstrate the company's capability to monitor and report adverse events or safety issues once the device is on the market.

4. Traditional Chinese Medicine-specific Regulations

• Herbal and Traditional Components: Since TCM devices often involve herbal medicines or traditional treatment methods (e.g., acupuncture, moxibustion), the NMPA review will also focus on ensuring that the components used in the device meet China’s herbal medicine regulatory standards.
  • For example, herbal ingredients must be sourced from authorized suppliers, and their efficacy must be supported by traditional knowledge or clinical studies.
  • Devices incorporating herbal components may require herb-based safety assessments or even clinical trials to demonstrate safety and effectiveness.
• Standards and Codes of Practice: The NMPA requires that TCM devices meet specific Chinese pharmacopoeia standards and align with national TCM regulatory guidelines for safety and efficacy.

5. Regulatory History and Previous Compliance

• Previous NMPA Approvals: The NMPA will review the enterprise’s regulatory history within China, including any past product approvals and compliance with Chinese medical device regulations.
• Other Market Approvals: If the TCM device has been approved or sold in other major markets (such as the EU, Japan, or the U.S.), the enterprise may be asked to provide evidence of these approvals as supporting documentation. However, approval in other markets does not guarantee acceptance in China; the device must still comply with local regulations.
• Adverse Event Records: Any previous adverse event reports, product recalls, or quality issues in the Chinese market will be examined.

6. Personnel and Expertise

• Qualified Personnel: The NMPA will assess whether the enterprise employs sufficient qualified personnel with expertise in both medical device manufacturing and Traditional Chinese Medicine. This includes personnel responsible for regulatory affairs, quality control, clinical trials (if applicable), and production.
• Training and Qualifications: The enterprise should provide details on employee training programs related to both general medical device manufacturing standards and TCM-specific practices.

7. Technical Documentation for the TCM Device

• Product Specifications: The enterprise must provide detailed specifications for the TCM device, including product design, materials, manufacturing processes, and the traditional medical principles underlying the device’s intended use.
• Clinical Trials: Depending on the type of TCM device, clinical data may be required to support its safety and efficacy. In some cases, NMPA may require clinical trials or preclinical testing to demonstrate that the device meets both TCM standards and general medical device safety standards.
  • The clinical data may focus on traditional efficacy, including case studies or evidence from recognized TCM practices, or more conventional scientific evidence depending on the nature of the device.

8. Post-Market Surveillance and Adverse Event Reporting

• Post-Market Obligations: Once the TCM device is registered, the enterprise must have an effective post-market surveillance system in place to monitor the safety and performance of the device after it is sold.
• Adverse Event Reporting: The company must establish procedures for reporting any adverse events or safety concerns to the NMPA. This is crucial for maintaining market authorization and ensuring patient safety.

9. Environmental and Safety Standards

• TCM device manufacturers must ensure that their products comply with applicable environmental protection and safety standards, including proper disposal of any components or materials that may be harmful to the environment.
• The enterprise must also ensure that safety standards are followed, particularly if the device involves electrical components, heating elements, or other technologies that could pose a safety risk.

10. Approval Process and Final Certification

• After completing the above background investigations, the NMPA will perform a detailed review of the application and any supporting documentation.
• If the enterprise and device meet all regulatory and safety requirements, the NMPA will issue the Registration Certificate for the TCM device, allowing it to be marketed in China.

Conclusion

The background investigation of TCM device enterprises during the NMPA certification process involves a comprehensive review of the company’s legal status, manufacturing capabilities, quality management systems, and adherence to both medical device and TCM-specific regulatory standards. The process also ensures that the enterprise complies with China’s national guidelines for safety, efficacy, and post-market surveillance. TCM devices, in particular, must also demonstrate compliance with herbal medicine regulations and may require additional clinical data or traditional evidence of efficacy.

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