Obtaining NMPA certification (formerly CFDA) for EEG machines in China involves several structured steps to ensure compliance with regulatory requirements. Here’s a detailed guide to the process:

1. Preparation Phase

1. Classification Determination:

   • Determine the classification of your EEG machine according to Chinese medical device regulations (Class I, II, or III). This classification will dictate the specific requirements and pathways for certification.

2. Technical Documentation Preparation:

   • Gather and prepare comprehensive technical documentation, including:
     • Device description and specifications.
     • Design drawings and manufacturing information.
     • Risk analysis and risk management documentation (ISO 14971).
     • Clinical evaluation report demonstrating safety and efficacy.
     • Quality management system (QMS) documentation compliant with GB/T 19001-2016 (ISO 9001:2015 equivalent).
     • Testing and evaluation reports (electrical safety, EMC, performance testing).

2. Testing and Evaluation

1. Testing Requirements:

   • Conduct testing of the EEG machine according to relevant Chinese national standards and technical requirements. This typically 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.

2. Clinical Evaluation:

   • Compile clinical data and evidence supporting the safety and effectiveness of the EEG machine. This may involve clinical trials or studies depending on the device classification.

3. Quality Management System (QMS)

1. QMS Implementation:
   • Implement a QMS that meets the requirements of GB/T 19001-2016 (ISO 9001:2015) to ensure consistent quality in manufacturing and compliance with regulatory standards.

4. Submission and Review

1. Document Submission:

   • Submit your technical documentation, test reports, and QMS documentation to a Chinese Testing Laboratory (CTL) accredited by NMPA for review and testing.

2. Application Submission:

   • Prepare and submit your application for NMPA certification through the online platform or designated submission channels. Include all required documentation and proof of compliance with regulatory requirements.

5. Review and Approval

1. NMPA Review:

   • NMPA will review your application, technical documentation, and test reports. They may conduct site inspections and audits to verify compliance with regulatory requirements.

2. Approval:

   • If your application is approved and your EEG machine meets all regulatory requirements, NMPA will issue a Registration Certificate. This certificate allows you to legally market and sell your device in China.

6. Post-Market Requirements

1. Post-Market Surveillance:

   • Implement post-market surveillance activities to monitor the performance and safety of your EEG machine in real-world use. Report any adverse events or incidents to NMPA as required.

2. Labeling and Advertising Compliance:

   • Ensure that labeling and advertising of your EEG machine comply with NMPA regulations, including mandatory information in Chinese.

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