China approved first medical device using real-world data

On March 26, the National Medical Product Administration approved the registration of “glaucoma drainage tube” of Elgin company of USA. This product is the first pilot product since the NMPA and Hainan Provincial Government jointly launched the trial work of clinical real-world data application in Hainan in June 2019. It uses the clinical real world evidence collected in the Pioneer Area of Boao Lecheng in Hainan to evaluate the ethnic differences, and is the first product approved and registered in China. The product is composed of a drainage tube and a syringe. The drainage tube is made of pigskin gelatinRead More →

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