NMPA issued the clinical trial audit result for an IVD manufacturer on April 16, 2024.
The audited firm is Guangdong Hexin. Its Respiratory Syncytial Virus, Influenza A Virus, Influenza B Virus, Adenovirus Antigen Combination Test Kit (Flow Cytometry Method – FITC/PE/Cy5/PC7) was applying for IVD registration. The clinical trial was found to have authenticity issues as following:
- The detection time of data summary table of 318 samples in this clinical trial is inconsistent with that recorded by the instrument,
- The virus identification result data in the clinical trial summary report is inconsistent with the original document.
The product will be discontinued from registration now. And it will not be allowed to register within one year from the date of disapproval.
IVD Clinical Trial Requirements
How to ensure IVD GCP complies with NMPA ever changing requirements? NMPA published the “Clinical Guideline for In Vitro Diagnostic Reagents” on September 27, 2021. It specifies that IVD clinical trial sites must be listed on the NMPA filed institutions for Medical Device Clinical Trial Sites. In addition, it requires using fresh samples, instead of stored sample, and statistically significant sampling size.
Click HERE for our comprehensive analysis on the guideline.
For more information on these changes please contact us at Info@ChinaMedDevice.com
How NMPA Audits Your Clinical Trial Institution
NMPA announced the “Measures for Supervision and Inspection of Medical Device Clinical Trial Institutions (Trial)” on March 12, 2024. These measures will be finalized to apply to the inspection and punishment, carried out by provincial medical products administrations, on the implementation of GCP for medical devices and IVDs.
For an English copy of the Measures with inspection checkpoints and judging principles, please email us at info@ChinaMedDevice.com. We charge nominal fees for the translation.
China Med Device, LLC has helped a company with clinical trial and clinical onsite inspection for its absorbable hemostatic powder, a Class III absorbable implants. Click HERE for more information. CMD’s proven approach of integrating technical, clinical and regulatory knowledge and experience has overcome the challenges along the way and expedited clients’ time to Chinese market.
Visit HERE for more info on the “Measures for Supervision and Inspection of Medical Device Clinical Trial Institutions (Trial)