When to Sign up as a Foreign Exporter

#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!
 
Elsmar Forum Sponsor

Al Rosen

Staff member
Super Moderator
#2
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"?
 
#5
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

Staff member
Super Moderator
#9
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
#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.
 
Thread starter Similar threads Forum Replies Date
S Study sign off question / responsibilities ISO 13485:2016 - Medical Device Quality Management Systems 3
Q Experience with Adobe Sign Document Control Systems, Procedures, Forms and Templates 3
O Inventory control ideas - I have an open stock room with a "sign out" book Manufacturing and Related Processes 9
E Why is the (theoretical) pH slope sometimes cited without the negative sign? General Measurement Device and Calibration Topics 1
S How to make Single Sign On (SSO) Comply e-sig requirements? ISO 13485:2016 - Medical Device Quality Management Systems 4
S Is Adobe Sign - E-signature for QMS documents - 21 cfr part 11 compliant? ISO 13485:2016 - Medical Device Quality Management Systems 2
W Job Card/Router sign off - Want to go paperless AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1
T Stamps vs Signatures - Stamps as inspection/approval sign-off vs. Initials Records and Data - Quality, Legal and Other Evidence 18
T Document Review And Sign Off Second Person Review - FDA Requirements ISO 13485:2016 - Medical Device Quality Management Systems 5
M Opportunity For Improvement - Customer to sign off or approve a new design ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
M Chrysler PSW Sign Off when your product is rated low risk in CQMS IATF 16949 - Automotive Quality Systems Standard 5
drgnrider Is there a specific OHSAS 18001 sign format? Occupational Health & Safety Management Standards 4
J A Euro sign on a print tolerance? Manufacturing and Related Processes 8
V Documents and Records - To sign or not to sign Document Control Systems, Procedures, Forms and Templates 6
Q Effective 1st Piece Inspection Sign Off Procedure Quality Manager and Management Related Issues 8
C Who in the supplier organization has to sign the PSW (Part Submission Warranty)? APQP and PPAP 6
C EN 60601-1:2012 - Requirement to use an Electrical Safety Sign on Products ISO 13485:2016 - Medical Device Quality Management Systems 2
B Control and Traceability of Sign-ups for Sales of a Product Career and Occupation Discussions 9
S How do you sign your letters? Coffee Break and Water Cooler Discussions 15
N Europe import Regulations? Customers are requesting us to sign OEM/ODM Agreements EU Medical Device Regulations 7
R Who must sign 510(k) Submission? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
Q Faking Data - Refusing to sign Falsified PPAP Submission package Nonconformance and Corrective Action 27
Sidney Vianna Boeing and Embraer sign Cooperation Agreement Coffee Break and Water Cooler Discussions 1
S Who has to sign off on supplier PPAP? IATF 16949 - Automotive Quality Systems Standard 1
Stijloor Hikers and Bikers - Sign in Florida Funny Stuff - Jokes and Humour 6
E Size of Sign - 95% of Confidence Using Minitab Software 13
J Can you use pencil to sign documents, fill out forms, etc? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 52
N Can we use a black pen to sign documents, fill out forms, etc? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 16
V Who should sign the Certificate of Attendance for In-House Training Training - Internal, External, Online and Distance Learning 7
O Corrective Action Sign-Off - Requirements and Responsibilities Nonconformance and Corrective Action 2
Jim Wynne Baseball Opening Day--A Sure Sign Of Spring Coffee Break and Water Cooler Discussions 3
M What to do when Auditee refuses to sign Audit Report General Auditing Discussions 91
apestate FAA Regulations: Is it ever OK to sign off on nonconforming type certified parts? Federal Aviation Administration (FAA) Standards and Requirements 8
V At what Stage of Equipment Qualification (IQ-OQ-PQ), must we sign-off the SOP? US Food and Drug Administration (FDA) 4
N Must you Sign on every Page of A Calibration Report General Measurement Device and Calibration Topics 6
C Product Quality Planning Summary and Sign Off Sheet APQP and PPAP 3
K Job Descriptions - Should employees sign their job descriptions? Why or why not? Career and Occupation Discussions 31
SteelMaiden Road sign in Florida Coffee Break and Water Cooler Discussions 2
M Moving from physical signatures to a paperless QMS - Process and approval sign offs ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 20
I Could We use electronic signatures rather than manual sign offs? ISO 13485:2016 - Medical Device Quality Management Systems 8
M Supplier Quality Statement - Clause that our non-certified suppliers could sign Supplier Quality Assurance and other Supplier Issues 14
F Who should Sign Supplier PPAP (Production Part Approval Process) documents? APQP and PPAP 13
J Ideas for Quality Policy Sign - What and Where? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
Scott Catron Warning Sign Generator - An essential part of your safety program... Coffee Break and Water Cooler Discussions 3
A Training Requirement - Required sign-off after being retrained ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
9 Drawing (Print) Sign-off questions Manufacturing and Related Processes 4
errhine Paperless office software - Electronicly sign process documentation with FAA approval Federal Aviation Administration (FAA) Standards and Requirements 7
B "SIGN" of the times Funny Stuff - Jokes and Humour 7
S Document Approval Matrix - What manager needs to sign what documents Document Control Systems, Procedures, Forms and Templates 11
T Elsmar Lions - Mozambique Lion Warning Sign Funny Stuff - Jokes and Humour 11

Similar threads

Top Bottom