Establishment registration FDA 'Foreign exporter'

J

JimBa

#1
#1
Hi,
Am just trying to understand the establishment registration requirmenmts for the FDA.
Can anyone tell me when one might use the 'Forein exporter' registration catagory?
Initial importers have to be registered with the FDA and communicate to them from whom they are importing and the listing requirments are taken care of by refering to the manufacturers listing. The manufacturer outside the USA needs to be registered as a manufacturer, list the products exported to USA and communicate to the FDA to whom they are exporting.

Is the 'Forein exporter' for when a customer in the USA is not registered as an initial importer? i.e. one may sell straight in to the USA without an initial importer?

Knowing when this registration is used will help me understand to situation.

Regards
JimBa
 
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Ajit Basrur

Ajit Basrur

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#2
#2
Hello JimBa,

Firstly pls note that I have deleted your duplicate post that was in another post and retained just this one to get focused responses.

The "Foreign Exporter" is defined per http://www.fda.gov/MedicalDevices/D...urDevice/RegistrationandListing/ucm053165.htm as -

Exports or offers for export to the United States (U.S.), a device manufactured or processed by another individual, partnership, corporation or association in a foreign country, including devices originally manufactured in the United States. A foreign exporter must have an establishment address outside the U.S.

This is different from the "Initial Importer" as the "Initial Importer" takes first title to devices imported into the U.S and is having a U.S. address.
 
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