The requirements for the number of clinical trials in NMPA registration of invasive blood pressure monitoring devices in China can vary based on factors such as the device's classification, intended use, complexity, and existing clinical evidence. While specific numerical requirements are not typically specified by the NMPA, manufacturers are expected to provide sufficient clinical data to demonstrate the device's safety, efficacy, and performance. Here are key considerations regarding the number and types of clinical trials:

1. Clinical Trial Design

• Type of Study: Depending on the device's risk classification and intended use, clinical trials may include randomized controlled trials (RCTs), non-randomized trials, observational studies, or equivalence studies.

• Controlled Trials: Comparative studies against standard treatment or existing devices may be required to establish superiority, non-inferiority, or equivalence.

2. Sample Size and Power

• Sample Size Calculation: Trials should have an adequate number of participants to ensure statistical power and reliability of study results.

• Statistical Significance: The trials should be powered to detect clinically meaningful differences in outcomes between the device and the comparator.

3. Data Collection and Analysis

• Comprehensive Data: Gather comprehensive clinical data, including baseline characteristics, treatment outcomes, adverse events, and long-term follow-up data as applicable.

• Statistical Analysis: Conduct robust statistical analysis to evaluate the device's safety, efficacy, and performance outcomes according to predefined endpoints.

4. Consistency and Reproducibility

• Multi-Center Trials: Conduct trials across multiple sites to ensure the generalizability and reproducibility of study findings across diverse patient populations and clinical settings.

• Data Consistency: Ensure consistency in data collection methods, device usage, and clinical assessments across all trial sites to minimize variability.

5. Regulatory Guidance and Expectations

• NMPA Requirements: Align clinical trial designs with NMPA regulatory requirements and guidelines, including those related to Good Clinical Practice (GCP) standards and ethical considerations.

• Documentation: Prepare comprehensive documentation, including clinical trial protocols, informed consent forms, clinical study reports, and regulatory submissions.

Contact Us：

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