The technical documentation required for obtaining an NMPA registration certificate for EEG machines in China should be comprehensive and well-organized. Here are the key technical document requirements:

1. Device Description and Specifications

• Detailed Device Description: Provide a thorough description of the EEG machine, including its intended use, design features, and operational specifications.
• Specifications: Outline technical specifications such as dimensions, weight, power requirements, input/output characteristics, and operational modes.

2. Design and Manufacturing Information

• Design Drawings and Schematics: Include detailed drawings, schematics, and diagrams that illustrate the design and construction of the EEG machine.
• Materials and Components: List all materials and components used in the construction of the device, specifying their properties and intended purpose.
• Manufacturing Processes: Describe the manufacturing processes used to produce the EEG machine, ensuring compliance with quality standards and regulations.

3. Risk Management Documentation

• Risk Analysis: Conduct a comprehensive risk analysis according to ISO 14971 standards. Identify potential hazards associated with the EEG machine and implement risk control measures to mitigate these risks.
• Risk Management Report: Provide a detailed report documenting the risk management process, including risk assessment, evaluation criteria, and justification of risk control measures.

4. Clinical Evaluation Report

• Clinical Data and Analysis: Include clinical data collected during the clinical evaluation process to demonstrate the safety, efficacy, and performance of the EEG machine.
• Clinical Evaluation Report (CER): Prepare a structured report summarizing the clinical evaluation findings, study objectives, methodology, patient demographics, data analysis, and conclusions regarding the device's clinical performance.

5. Quality Management System (QMS) Documentation

• QMS Implementation: Implement a quality management system that complies with GB/T 19001-2016 (ISO 9001:2015 equivalent) standards.
• QMS Documentation: Provide documentation that demonstrates the establishment, implementation, and maintenance of the QMS. This includes procedures, work instructions, quality records, and evidence of internal audits and management reviews.

6. Testing and Evaluation Reports

• Electrical Safety Testing: Conduct testing according to relevant standards (e.g., IEC 60601-1) to ensure electrical safety compliance.
• Electromagnetic Compatibility (EMC) Testing: Perform EMC testing (e.g., IEC 60601-1-2) to assess the device's immunity to electromagnetic interference and emissions.
• Performance Testing: Conduct performance testing to verify accuracy, reliability, and operational characteristics of the EEG machine.

7. Labeling and Instructions for Use

• Labeling Requirements: Ensure labeling complies with NMPA regulations, including device identification, manufacturer information, intended use, warnings, and instructions for use (IFU).
• IFU: Provide clear and comprehensive instructions for use that outline device operation, setup procedures, maintenance instructions, and safety precautions.

8. Other Documentation

• Declaration of Conformity: Include a declaration stating that the EEG machine conforms to applicable Chinese regulatory requirements and standards.
• Authorized Representative: If applicable, provide documentation appointing an authorized representative in China responsible for regulatory compliance.

Submission and Review Process:

• Compile all technical documentation into a complete and organized dossier.
• Submit the application and documentation package through NMPA’s designated online platform or submission channels.
• Prepare to respond to any additional requests or clarifications from NMPA during the review process.
• Upon successful review and approval, NMPA will issue a registration certificate allowing you to legally market and sell your EEG machine in China.

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