Curious: As a foreign manufacturer (i.e. located outside the US), can I ship directly to a customer in the US (assuming, of course, that we've met all FDA requirements for foreign manufacturer - establishment listing, device listing, quality system, US Agent, pre-market approval)?
I don't see why not, were it not for the designation of a "initial importer", which is necessary for device listing.
Can we designate ourselves as the "initial importer"? ...or do we have to source someone in the US to act in this capacity? If so, what would they do in such an arrangement? Would we have to ship to them first, and then they forward the package to the final customer? ...or is there a way that we can just ship directly to the US customer without involving another party?
Any insight is much appreciated!
MM.
I don't see why not, were it not for the designation of a "initial importer", which is necessary for device listing.
Can we designate ourselves as the "initial importer"? ...or do we have to source someone in the US to act in this capacity? If so, what would they do in such an arrangement? Would we have to ship to them first, and then they forward the package to the final customer? ...or is there a way that we can just ship directly to the US customer without involving another party?
Any insight is much appreciated!
MM.