Demonstrating clinical evidence for NMPA registration (National Medical Products Administration) of invasive blood pressure monitoring devices in China involves conducting robust clinical studies that validate the device's safety, efficacy, and performance in clinical settings. Here's a structured approach on how to demonstrate clinical evidence for NMPA registration:

1. Study Design and Objectives

1. Define Clear Study Objectives:

   • Clearly state the primary objectives of the clinical study, focusing on evaluating the device's performance parameters such as accuracy, precision, and usability in measuring invasive blood pressure.

2. Select Appropriate Study Design:

   • Choose an appropriate study design (e.g., randomized controlled trial, non-randomized trial, observational study) based on device classification, intended use, and regulatory requirements.
   • Consider the need for comparative studies against existing devices or methods to establish superiority, non-inferiority, or equivalence.

2. Patient Population

1. Inclusion and Exclusion Criteria:

   • Define specific criteria for patient enrollment that align with the intended use population for the device. Consider factors such as age, medical history, and clinical conditions affecting blood pressure.

2. Diversity in Participants:

   • Ensure diversity in participant demographics to reflect the real-world clinical application of the device.

3. Device Installation and Training

1. Device Handling and Training:
   • Implement procedures for device installation, calibration, and operation according to manufacturer instructions and study protocol.
   • Provide training to investigators and site staff on device usage, data collection methods, and adherence to study protocols.

4. Data Collection and Analysis

1. Data Collection Methods:

   • Standardize procedures for collecting and recording data on invasive blood pressure measurements obtained using the device.
   • Include protocols for timing of measurements, patient positioning, and conditions under which measurements are taken.

2. Statistical Analysis:

   • Plan robust statistical analyses to evaluate the device’s performance compared to reference methods or devices.
   • Calculate metrics such as sensitivity, specificity, accuracy, precision, and other relevant performance parameters.
   • Use appropriate statistical tests (e.g., t-tests, ANOVA, correlation analysis) to assess the significance of study findings.

5. Safety Monitoring and Adverse Events

1. Safety Monitoring:
   • Implement procedures for monitoring participant safety throughout the study period.
   • Document and report any adverse events or device-related complications according to regulatory requirements.

6. Ethical Considerations

1. Ethical Approval:
   • Obtain approval from an independent ethics committee (Institutional Review Board - IRB) or Ethics Review Board (ERB) at each study site.
   • Ensure compliance with ethical principles, participant rights, and confidentiality of participant data.

7. Documentation and Reporting

1. Clinical Study Report:
   • Prepare a comprehensive clinical study report that summarizes the study objectives, methods, participant demographics, data analysis results, and conclusions regarding the device’s performance.
   • Include detailed descriptions of study protocols, statistical analyses, and graphical representations of study findings.

Contact Us：

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