Multiple distributors in Spain

C

ccowles

My US company has CE mark for our portable oxygen concentrator, Class IIa medical device.

We want to sell into Spain; I understand the AEMPS process. If we have a distributor complete this process for us, can other distributors sell the product? Or can only the registering distributor sell (exclusivity)?

Any insight would be helpful.
 
P

Pads38

Moderator
As you are outside the EU (USA) you will need an "Authorised Representative", within the EU, who becomes the official point-of-contact for all EU authorities. The AR has certain legal responsibilities.

You can have as many distributors as you like, one (and only one) of which may also act as your Authorised Representative.

Welcome to the Cove!
 
C

ccowles

Thank you for your reply.

Here is a little more clarification. We do have an EU Rep, MTP located in Germany. They said we can either have them, for a fee notify Spain of our medical device OR have a local Spanish distributor do this for us.

If we go the route of using a local distributor does that limit us to only having them sell the product? Or can others have access even though they didn't register?

Again thank you for the help!!
 
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