Foreign Exporter Establishment registration



Hi Guys,

Company A from one country sells its manufactured Medical devices to company B in other country.

Company B wants to export these devices to Company C in US. Do Company B needs to register as a foreign exporter with USFDA?

The online guidance do mentions about the initial registration of manufacturers, processor and initial importers, however, nothing specific on what is expected to be filled out by a foreign exporter when doing a FURLS account

Any guidance is highly appreciated.



Company B would be a Foreign Exporter and is required to register.

EDIT: I am banned from posting links due to a low post count. You should be able to find the quoted text below by searching "Who Must Register, List and Pay the Fee" in the Device Advice Section of the FDA Website.

Foreign Exporter - Exports or offers for export to the United States (U.S.), a device manufactured, prepared, propagated, compounded, or processed in a foreign country, including devices originally manufactured in the United States. A foreign exporter must have an establishment address outside the U.S.


I can tag along with this to say with Company B would need to register. The thought process behind Foreign Exporters having to register, list, and pay fees to US FDA for exporting products for import in the United States is to basically keep track of all these entities. Exactly in the scenario that you stated meena. Traditionally foreign manufacturers would export their products to a company inside the U.S. such as a partner, sister company, or distributor. Then there is no specific need for registering as a Foreign Exporter - but for cases like you described.
Top Bottom