The technical documentation required for NMPA certification (formerly CFDA) for EEG machines in China should be comprehensive and demonstrate compliance with Chinese regulatory requirements. Here are the key technical documents typically required:

1. Device Description and Specifications:

   • Detailed description of the EEG machine, including its intended use, indications, and technical specifications (e.g., model numbers, dimensions, weight).
   • Specifications for all components and accessories included with the device.

2. Design and Manufacturing Information:

   • Design drawings and schematics showing the construction and operation of the EEG machine.
   • Manufacturing process description, including details on materials used, assembly procedures, and quality control measures.

3. Risk Management Documentation:

   • Risk analysis according to ISO 14971 or equivalent standards, detailing identified hazards, risk assessment, and risk control measures implemented to mitigate risks.

4. Clinical Evaluation Report:

   • Clinical data demonstrating the safety and efficacy of the EEG machine. This may include clinical study reports, literature reviews, and clinical performance evaluations.

5. Quality Management System (QMS) Documentation**:

   • Documentation proving compliance with a QMS that meets the requirements of GB/T 19001-2016 (equivalent to ISO 9001:2015). This includes:
     • Quality policy and objectives.
     • Organizational structure and responsibilities.
     • Procedures and work instructions.
     • Records of QMS implementation and monitoring.

6. Technical Testing Reports:

   • Test reports from accredited testing laboratories demonstrating compliance with relevant Chinese national standards and technical requirements. This includes:
     • Electrical safety testing (e.g., IEC 60601-1).
     • Electromagnetic compatibility (EMC) testing (e.g., IEC 60601-1-2).
     • Performance testing to verify accuracy, reliability, and operational characteristics.

7. Labeling and Instructions for Use (IFU):

   • Labeling information including the device label, packaging label, and user manual.
   • Instructions for Use (IFU) in Chinese, detailing device operation, indications, contraindications, and precautions for safe use.

8. Clinical Trial Data (if applicable):

   • If clinical trials were conducted to support the device’s performance and safety, include the clinical trial protocol, results, and conclusions.

9. Declaration of Conformity:

   • A declaration stating that the EEG machine conforms to all applicable Chinese regulatory requirements, standards, and technical specifications.

10. Supplier Information:

    • Information about the manufacturer and/or authorized representative, including contact details and legal authorization documents.

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