The National Medical Products Administration (NMPA) in China oversees the certification and regulation of medical devices, including traditional Chinese medicine (TCM) equipment. The standards and audit requirements for obtaining a certificate for TCM medical devices are typically based on a combination of national regulations, industry standards, and specific guidelines related to TCM.

Here are some key points regarding the standards and audit requirements for TCM medical equipment certified by NMPA:

1. Regulatory Framework: TCM medical devices are classified according to their risk level (Class I, II, or III), which affects the level of scrutiny during the approval process. The higher the class, the more stringent the requirements.

2. Quality Management System (QMS): Manufacturers must implement a QMS compliant with the ISO 13485 standard, which outlines requirements for a comprehensive management system for the design and manufacture of medical devices. This includes documentation, processes, and continuous risk management.

3. Technical Standards: Relevant Chinese national standards (GB standards) and industry standards related to medical devices must be met. These may include specific requirements for the performance, safety, and efficacy of TCM medical equipment.

4. Product Testing: Pre-market clinical trials or performance testing may be required, especially for higher-risk devices. The results must demonstrate the safety and effectiveness of the device.

5. Documentation: Submission of a complete technical dossier is required, including:

   • Product description and intended use
   • Manufacturing processes and specifications
   • Quality control measures
   • Clinical evaluation data (if applicable)
   • Risk analysis

6. Audits and Inspections: NMPA conducts audits and inspections of manufacturing facilities to ensure compliance with regulatory requirements, quality management systems, and safety standards.

7. Post-market Surveillance: After certification, manufacturers are required to conduct post-market surveillance and report any adverse events or product defects.

8. Labeling Requirements: Accurate labeling according to national standards is necessary, including information on usage, contraindications, and user instructions.

9. Compliance with Traditional Medicine Guidelines: Since the equipment is focused on TCM, adherence to specific guidelines that pertain to the practice of traditional Chinese medicine is essential.

It is important for manufacturers to stay updated on regulations and potentially engage with local regulatory consultants to navigate the certification process effectively.

Contact Us：

Whatsapp or Wechat：+86 15816864648；email address：hito.lin@grzan.cn