We are a U.K based company with one device that has 510(K) approval. For the last two years we have had a nationwide distributor who have been registered as the initial importer of the device. We have now entered into discussions with another company. Can we have more than one initial importer for the device?
I have read all the guidance and can't see anything to say that you can or can't have more than one.
Any guidance would be much appreciated.
I have read all the guidance and can't see anything to say that you can or can't have more than one.
Any guidance would be much appreciated.