When to Sign up as a Foreign Exporter

yellaham

Registered
Hello,

I have a few questions regarding the "Foreign Exporter" rule. I've read the FDA website regarding who must register and such but am still a bit confused. I'm trying to send them to an Amazon warehouse am caught up. I'm importing my products from China and there are 2 situations:

Situation 1: Chinese Manufacturer (Has active FDA registry), sells and ships to Company B in Canada. Company B gets a customs broker and sends the products into the USA to the Amazon Warehouse.

Question: Does Company B have to register as a Foreign exporter even if the manufacturer has an active FDA registration number and certificate?

Situation 2: Chinese Manufacturer (Has active FDA registry) develops and brands the goods for Company B. But instead of shipping to Company B in Canada, the Chinese Manufacturer ships straight to the Amazon warehouse.

Question: Does Company B have to register as a Foreign exporter?

Thank you in advance!
 

Al Rosen

Leader
Super Moderator
Hello,

I have a few questions regarding the "Foreign Exporter" rule. I've read the FDA website regarding who must register and such but am still a bit confused. I'm trying to send them to an Amazon warehouse am caught up. I'm importing my products from China and there are 2 situations:

Situation 1: Chinese Manufacturer (Has active FDA registry), sells and ships to Company B in Canada. Company B gets a customs broker and sends the products into the USA to the Amazon Warehouse.

Question: Does Company B have to register as a Foreign exporter even if the manufacturer has an active FDA registration number and certificate?

Situation 2: Chinese Manufacturer (Has active FDA registry) develops and brands the goods for Company B. But instead of shipping to Company B in Canada, the Chinese Manufacturer ships straight to the Amazon warehouse.

Question: Does Company B have to register as a Foreign exporter?

Thank you in advance!
In situation 1, I company B is the foreign exporter that registers and lists.
In suituation 2, define "Brands the goods for Company B"?
 

yellaham

Registered
Is company B's name going on the label in addition to the Chinese mfr?
The Chinese manufacturer's name/brand won't be on the packaging. They'll be designing the packaging with our company name and design. They'll also be packaging & shipping the items from China to a USA FBA warehouse
 

Al Rosen

Leader
Super Moderator
They’ll be the ones selling the items in the us
They might be considered a Foreign Exporter.
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.
Foreign exporters need to register, list devices and pay fees.
 

gogreen

Starting to get Involved
Another issue you will have is on the initial importer front. You will not be able to clear FDA review at customs without an FDA-registered initial importer. Amazon will not serve in the role, to my knowledge.
 
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