Real-World Evidence For NMPA Premarket Clinical Evaluation


This short video discusses the use of real-world evidence to support your NMPA premarket clinical evaluation. Real-world data can support distinctions between class II and class III medical devices, including IVD. Real-world data can be utilised in conjunction with clinical data to support racial differences. There are 11 uses of real-world evidence for the life-cycle clinical review of medical devices in China, according to the Guidance of Using Real-World Data (RWD) for Medical Device Clinical Evaluation in China.