Distributor for a SaMD

[Yael LP]

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!

 

[mihzago]

You do not. You still need a US Agent though.

 

[Yael LP]

many thanks!
can you refer me to relevant fda guidance? coudlnt find it.

what about EU? any idea what is a must beside AU-REP?

 

[mihzago]

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.