NMPA is paying more and more attention to clinical trial authenticity audit in IVD as well. Just want to share critical guidelines so that you are aware of what to follow and how to stay compliant for your valuable clinical trial results and efforts. To ensure compliance with NMPA's evolving requirements for IVD clinical trials, following the "Clinical Guideline for In Vitro Diagnostic Reagents," published on September 27, 2021, is crucial. This guideline emphasizes listing trial sites with NMPA, using fresh samples, and maintaining statistically significant sample sizes.
Furthermore, NMPA has introduced "Measures for the Supervision and Inspection of Medical Device Clinical Trial Institutions", aiming to enforce Good Clinical Practice standards.
NMPA recently conducted a clinical trial audit for an IVD manufacturer for Respiratory Syncytial Virus, Influenza A Virus, Influenza B Virus, Adenovirus Antigen Combination Test Kit. Discrepancies were identified in the trial's data summary table and virus identification results. It is really important that the manufacturer and CRO should pay attention to its data analysis and follow the guideline.
Please feel free to reach out if you would like a copy of the Measures with inspection checkpoints and judging principles.
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Grace Fu
China Med Device, LLC
gpalma@ChinaMedDevice.comPhone US: (978) 390-4453
Phone China: 18201749732
www.ChinaMedDevice.com------------------------------