Obtaining NMPA certification for EEG machines involves several detailed procedures and steps. Here’s a comprehensive guide to help you navigate through the process:

1. Classification and Regulatory Pathway

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

• Regulatory Pathway: Choose the appropriate regulatory pathway based on the classification and intended use of your EEG machine. This could be either through the Registration Certificate (Class II and III devices) or the Record Filing (Class I devices) process.

2. Preparation Phase

• Technical Documentation: Gather and prepare comprehensive technical documentation. This includes:

  • Design drawings, specifications, and labeling information.
  • Risk analysis and mitigation documentation.
  • 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: Conduct necessary testing and evaluation of the EEG machine. This typically includes:

  • Electrical safety testing.
  • Electromagnetic compatibility (EMC) testing.
  • Performance testing to demonstrate accuracy and reliability.

3. Clinical Evaluation

• Clinical Data: Compile clinical data and evidence supporting the safety and performance of your EEG machine. This may involve clinical trials or studies, depending on the device classification and regulatory requirements.

4. Quality Management System (QMS)

• Implementation: Establish and implement a QMS that complies with Chinese standards. Ensure that your manufacturing processes and facilities adhere to these standards.

5. Submission and Review

• Testing and Evaluation: Submit your technical documentation and test reports to a Chinese Testing Laboratory (CTL) accredited by NMPA for review and testing. The CTL will assess whether your EEG machine meets relevant Chinese standards and technical requirements.

• Application Submission: Prepare and submit your application for NMPA certification through the online platform. Include all required documentation, test reports, and proof of compliance with Chinese regulatory requirements.

6. Review and Approval Process

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

• 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 market and sell your device legally in China.

7. Post-Market Surveillance

• Post-Market Requirements: Comply with post-market surveillance requirements as specified by NMPA. This includes monitoring the performance and safety of your EEG machine once it is in use in China.

Additional Tips:

• Consultation: Consider working with a local regulatory consultant or agent in China who specializes in medical device registration. They can provide guidance and assistance throughout the certification process.

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

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