Distributor for a SaMD

#1
Hi

My company is the manufacturer of a SaMD.
The distrbituion is done by download the software from dedicated server, URL, or even appstroe.
Since all is "virtual" do we need to have distributor?
Specifically, if we are manufacturing company located outside of US and EU, do we need to have distributers there?


Many thanks!
 
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mihzago

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#4
U.S. Agents

In EU, assuming you have a class I device, which will likely change under the EUMDR, you need Authorized Rep and probably GDRP local representative as required by Article 27.
 
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