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 evaluation is one of the essential steps if western companies want to register new medical products in China. Manufacturers need to prove the safe and effective of their products as well as it meets its design goal and intended use by submitting clinical evaluation data to NMPA (CFDA). China Med Device’s experienced and local contract research organization (CRO) team specialized in providing turnkey solution for China regulatory compliance clinical evaluation data for medical device/IVD/CDx/combination product. Our team of experts has 10+ years of experience writing clinical evaluation report (CER) and conducting clinical trial (CT) to meet Chinese requirements. Our CRO service include but not limited to:
- Clinical Pathway strategy
- Clinical Evaluation Report Writing
- Overseas clinical data feasibility evaluation, differences analysis and justification, submission and follow-up
- Complete local clinical trial implementation
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.
Possible clinical pathways for medical device and IVD registration in China: