How Many Sites Should Be Considered For A Medical Device Clinical Trial?


2021-11-05

Single site is not recommended for medical device clinical trials. As per China GCP requirements, at least two sites should be considered for clinical trials in China. Please note that the China Fast Track pathway offers great opportunities to discuss with NMPA on protocol design, site selection, sample size, etc.
Takeaway: Consider multi-center study design when planning a clinical trial in China