Hello all,
I am currently working with a customer on registering their device in China and received some feedback that I need help addressing. For background, my company is the sponsor of the clinical protocol, but we partner with clinical sites in order to obtain subject samples and manage clinical outcomes. This trial has already been successfully accepted by the FDA and led to an EUA of the device. The feedback we've received from the NMPA via our customer is:
1. The firm mainly engaged in the R & D, manufacturing and sales of IVD and other products, which is not a clinical institution and does not have the ability to recruit relevant subjects, manage trials and control risks in the trial process.
2. Can [sponsor] provide evidence that they can initiate a clinical trial?
3. Please confirm whether [sponsor] suitable for conducting clinical trials and submit the regulatory basis.
My group is a little in the dark as to what evidence they might be looking for. Does anyone have experience with these types of submissions/feedback?
Thanks,
Joscelyn
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Joscelyn Bowersock MSc
Director, Quality Affairs and Regulatory
United States
joscelyneb@outlook.com------------------------------