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 and real-world data/study.
Clinical evaluation is essential for western companies to register new medical products in China. Manufacturers must prove the safe and effectiveness of their products, as well as their compatibility with the design goals and intended use, by submitting clinical evaluation data to NMPA (CFDA). China Med Device’s experienced and local contract research organization (CRO) specializes in providing turnkey solution for China regulatory compliance clinical evaluation data for medical device/IVD/CDx/combination product. Our expert team has m0re than 10 years of experience writing clinical evaluation reports (CERs) and conducting clinical trials (CTs) to meet Chinese requirements. Our CRO service include:
- 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
Is your device exempt from a clinical trial in China? Assessing this is the first critical step in registration strategy. If a clinical trial is necessary, which clinical pathway is most appropriate after balancing cost, schedule, and risk to meet regulatory compliance? Understanding and determining the optimal clinical pathway will reduce costs and shorten the your time to access the Chinese market. China Med Device helps you assess the latest NMPA requirements and review your current clinical data to identify the best clinical conformity pathway in China.
Possible clinical pathways for medical device and IVD registration in China: