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Different clinical pathways and how to decide which pathway to choose to support the National Medical Products Administration (NMPA) medical device/in vitro diagnostic (IVD) regulatory submission or postmarket surveillance;
Key areas you need to pay attention to so as to have the right strategy and tactics to shorten clinical trials and approval times;
Whether your devices qualify for the real-world data/study Hainan program and how to get into the program;
Key considerations on the feasibility and justification of overseas clinical data acceptance;
Strategies to improve the overall contract research organization(CRO) process and get your new products to the Chinese population faster: clinical trial study design and clinical trial protocol, calculation of sample size, on-site management and data integrity.
Once you understand these regulatory developments, you’ll reduce your clinical trial costs and get your devices to the Chinese market faster.
