When to Sign up as a Foreign Exporter

Y

yellaham

Registered
#1
#1
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!
 
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Al Rosen

Al Rosen

Leader
Super Moderator
#2
#2
yellaham said:
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!
Click to expand...
In situation 1, I company B is the foreign exporter that registers and lists.
In suituation 2, define "Brands the goods for Company B"?
 
Y

yellaham

Registered
#5
#5
Al Rosen said:
Is company B's name going on the label in addition to the Chinese mfr?
Click to expand...
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

Al Rosen

Leader
Super Moderator
#9
#9
yellaham said:
They’ll be the ones selling the items in the us
Click to expand...
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.
Click to expand...
Foreign exporters need to register, list devices and pay fees.
 
G

gogreen

Starting to get Involved
#10
#10
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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