Can You Explain The Strategy Of Oversea Clinical Data For Medical Device Registration In China?


2021-10-18

For the overseas clinical data, let us say, if you have done a pivotal study in the US or in other markets, you wanted to use the collected data to seek NMPA approval, you definitely can use these data. However, always keep in mind, one of the key requirements to make this strategy successful to write a report proving that your data collected from overseas can be extrapolated to Chinese patients. This is the key to submit the overseas clinical data.