Ethical requirements for NMPA registration of EEG machines in China are critical to ensure the protection of human subjects participating in clinical studies and to uphold ethical standards in medical research. Here are the key ethical considerations and requirements to adhere to:

1. Ethics Committee Approval

• Submission and Review: Obtain approval from an accredited Ethics Committee (EC) or Institutional Review Board (IRB) in China before initiating any clinical study involving human subjects.

• Protocol Review: Submit the study protocol, informed consent forms, patient recruitment materials, and any other relevant documents for review by the EC/IRB.

• Informed Consent: Ensure that participants or their legally authorized representatives provide informed consent voluntarily, after understanding the study's purpose, procedures, risks, benefits, and their rights.

2. Participant Rights and Safety

• Beneficence and Non-maleficence: Ensure that the study design and procedures prioritize participant safety and well-being, minimizing risks and potential harm.

• Confidentiality: Implement measures to protect participants' confidentiality and privacy, including secure handling of personal data and medical information.

• Withdrawal: Allow participants the right to withdraw from the study at any time without penalty or negative consequences.

3. Study Conduct and Monitoring

• Good Clinical Practice (GCP): Conduct the study in accordance with GCP guidelines, ensuring that data collection, documentation, and reporting adhere to high ethical and scientific standards.

• Safety Monitoring: Implement procedures for monitoring and reporting adverse events or serious adverse events (SAEs) related to the EEG machine or study procedures.

4. Ethical Considerations for Vulnerable Populations

• Special Populations: If the study includes vulnerable populations (e.g., children, elderly, pregnant women), justify their inclusion based on scientific necessity and ensure additional safeguards to protect their rights and welfare.

5. Regulatory Compliance

• NMPA Requirements: Comply with specific NMPA regulations and guidelines related to ethical conduct of clinical studies for medical devices, including EEG machines.

6. Documentation and Reporting

• Ethical Approval Documentation: Maintain documentation of EC/IRB approval, informed consent forms, and all correspondence related to ethical considerations throughout the study.

• Adverse Event Reporting: Promptly report any adverse events or SAEs to the EC/IRB and regulatory authorities as required by local regulations.

7. Training and Education

• Research Personnel: Ensure that all individuals involved in the study, including investigators, study coordinators, and site personnel, are trained in ethical principles and compliance with study protocols.

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