Implement a robust post-market surveillance system to monitor the performance of the multi-parameter monitors once they are in use. This includes gathering feedback from users, handling complaints, and reporting adverse events to the NMPA as required.

Detailed description of the multi-parameter monitor, including its intended use, design features, and specifications (e.g., dimensions, weight, materials).

Device Classification: Determine the classification of your multi-parameter monitor according to NMPA regulations (Class I, II, or III). This classification dictates the regulatory pathway and requirements.

Determine Classification: Verify the classification of your multi-parameter monitor under NMPA regulations. Classification is crucial as it determines the regulatory requirements and applicable standards.

Obtaining ethical approval for NMPA registration of EEG machines involves following specific procedures to ensure that clinical studies comply with ethical standards and safeguard the rights and well-being of study participants.

Review NMPA Guidance: Understand the specific requirements and guidelines outlined by NMPA for clinical evidence supporting the registration of EEG machines. This includes requirements for study design, endpoints, patient populations, and statistical analysis.

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.

Define Clear Objectives: Clearly state the primary and secondary objectives of the clinical study. Focus on what specific aspects of the EEG machine's performance you aim to evaluate (e.g., diagnostic accuracy, usability).