The application process for obtaining an NMPA registration certificate for EEG machines in China involves several structured steps, including clinical evaluation. Here’s a detailed guide to the process:

1. Preparation Phase

1. Device Classification:

   • Determine the classification of your EEG machine according to Chinese medical device regulations (Class I, II, or III). This classification will determine the specific requirements and pathway 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 plan and 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. Clinical Evaluation

1. Clinical Data Compilation:
   • Collect and compile clinical data supporting the safety and efficacy of your EEG machine. This may include:
     • Clinical trial data (if applicable).
     • Literature reviews and summaries of relevant clinical studies.
     • Post-market surveillance data from similar devices, if available.
2. Clinical Evaluation Report:
   • Prepare a comprehensive clinical evaluation report that summarizes and analyzes the clinical data. The report should demonstrate how the EEG machine meets safety and performance requirements according to Chinese regulations.

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. Testing and Evaluation

1. Testing Requirements:
   • Conduct necessary 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.

5. Submission and Review

1. Document Submission:

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

2. Application Preparation:

   • Prepare your application for NMPA certification, including all required documents and forms. Ensure that all documents are accurate, complete, and organized according to NMPA requirements.

6. Application Submission

1. Online Submission:
   • Submit your application for NMPA certification through the NMPA's online platform or designated submission channels. Ensure that all required documents are uploaded and submitted according to the guidelines provided.

7. Review and Approval

1. NMPA Review:

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

2. Approval:

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

8. 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.

Additional Tips:

• Consultation: Work with a local regulatory consultant or agent in China who specializes in medical device registration. They can provide guidance, assist with document preparation, and facilitate communication with NMPA and testing laboratories.

• Timelines: Be prepared for varying timelines for different stages of the certification process. The overall process can take several months to over a year, depending on factors such as device complexity and regulatory review times.

Contact Us：

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