China Med Device provides turnkey solutions for all clinical pathways in medical device/IVD/CDx/combination products.
Key clinical pathways are: Clinical evaluation report (CER), and clinical trial, overseas clinical data acceptance.
Clinical Pathway Assessment and Determination
Assessing whether your device is clinical trial exempt in China is a first critical step in any regulatory registration strategy. If your product is not clinical trial exempt, which clinical pathway is most appropriate after balancing cost, schedule, and risk to meet regulatory compliance? Understanding and determining the possible clinical pathway will save your cost and shorten your time to China Market. China Med Device will first help you assess the latest NMPA requirements as well as your current clinical data to identify the best clinical conformity pathway in China.