Mark Meer

Trusted Information Resource
Trusted
#1
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.
 

Ronen E

Just a person
Super Moderator
#2
Why would you think that there has to be an Initial Importer?

As far as I know you’re allowed to sell directly to end users, in which case they will be the “importers” (without “initial”).

The FDA definition of Initial Importer:

An initial importer is any importer who furthers the marketing of a device from a foreign manufacturer to the person who makes the final delivery or sale of the device to the ultimate consumer or user, but does not repackage, or otherwise change the container, wrapper, or labeling of the device or device package.
(My emphasis)

See Importing into the U.S.
 

Mark Meer

Trusted Information Resource
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#3
I guess I'm confused because the device registration requires specifying an "importer".

I don't see much in the FDA documents with respect to the requirements of an "importer", only those of an "initial importer".

So, if an "importer" has to be specified, I'm curious: what are the requirements? Can I simply designate my (foreign) organisation as the importer? It makes no sense to designate a customer as the importer (at least as far as device registration is concerned), as there are many customers.
 

Mark Meer

Trusted Information Resource
Trusted
#4
UPDATE:

I've gone back to our FURLS device registration, and can't seem to find the "importer" field that I KNOW I skipped some months back when I was going through the registration process.

Despite skipping specifying an importer, it appears that the registration is complete (at least, the device now shows up on a public search). So it seems there is no problem with just skipping the step to specify an importer.

That being said, if anyone can confirm this, it'd still be appreciated, as the requirement (if it is a requirement) is still fuzzy to me.

Online articles like this one, seem to confuse the issue as they state in one place that foreign manufacturers must appoint an initial importer (i.e. it is a requirement), but then later say that it's "typical" for one to be appointed. :/
 

Ronen E

Just a person
Super Moderator
#5
Online articles like this one, seem to confuse the issue as they state in one place that foreign manufacturers must appoint an initial importer (i.e. it is a requirement), but then later say that it's "typical" for one to be appointed. :/
Never forget that LinkedIn is a promotional website; always double check your sources and the content they publish (yes, that includes me and Elsmar in general).

Back to the point (for the sake of anyone’s interest):

I found this note in the DRLM step-by-step guidance for device listing, under “Select activities”:

Note: Foreign Facilities should select any and all activities that are performed at each facility. The United States Bioterrorism Act of 2002 requires that the registration numbers for U.S. importers of all products be recorded. Be sure to complete this portion of the form.
(The emphasis is mine)

This can “technically” be read to say that if registration numbers exist, they must be recorded. For example, in your case (direct sales to end users) no importers are required to register and therefore no such registration numbers exist and are not necessary for completing the listing. The fact that you were apparently able to proceed without recording any numbers, is an indication for me that this interpretation may be right.
 
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