FDA - Can we have more than 1 Initial Importer

katiesam

Starting to get Involved
#1
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.
 
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gogreen

Starting to get Involved
#2
I think you can get your answer from the definition of initial importer. It says, in part: "Any importer who furthers the marketing of a device from a foreign manufacturer..." I read this to mean that, for a given device, each importer who furthers marketing from a foreign manufacturer is an initial importer.

Practically speaking, prohibiting more than one initial importer often would, in effect, require foreign establishments to have exclusive arrangements with distributors. Wouldn't make sense to require this of the market.
 

Ajit Basrur

Staff member
Admin
#3
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.
Absolutely "Yes"
 

Thee Bouyyy

Involved In Discussions
#5
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.

Yes, you can
:agree1:
 
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