Hello, I would like to ask if foreign medical device manufacturers need a medical device manufacturing license in China?

The question is a bit confusing, so let's organize it. If a foreign company manufactures imported medical devices and sells them in China, the qualifications of the seller should be "business license" and "medical device license", because the seller doesn't manufacture in China, so it doesn't need to apply for "medical device manufacturer's license". The first step is to make sure that you have a good understanding of how to use the device and how to make it work.

In addition, imported medical devices should also obtain the "medical device import registration certificate" issued by the SFDA before they can be marketed.