Foreign Exporter (confused)

#1
Hello everybody,

I am looking for some advice regarding selling class 2 medical device in the US (through Amazon fulfilment).
UK based Company A buy class 2 medical devices from Chinese Manufacturer (Company B). These are currently sold in the European market and have all the CE approval (COMPANY A do not have any certification, only COMPANY B)
But there is an agreement where COMPANY B agrees to having COMPANY A logo on the packaging/product and include these designs in their own technical file.

COMPANY B also have FDA approval for the product.
COMPANY A now want to sell this product through Amazon US & send the product to Amazon fulfilment centers. Therefore COMPANY A will be importing the product into the US.

Please can you advise where this leaves us. After unscrambling my brain I believe we may be classed as a 'Foreign Importer' and will be required to pay the annual FDA registration fee and also list the product we will import.

Any help would be appreciated.

Many thanks.
Jon
 
Elsmar Forum Sponsor

monoj mon

Involved In Discussions
#2
After unscrambling my brain I believe we may be classed as a 'Foreign Importer'
You are outside the US and exporting the devices manufactured outside the US to be sold in the US. So, you are "Foreign Exporter", not "Foreign Importer". There is no such thing called "Foreign Importer" in the FDA list.

Edit: You will be required to perform all the three functions
1. Register your facility
2. List your device
3. Pay the annual fee
 
Last edited:

monoj mon

Involved In Discussions
#3
Important: Foreign facilities must identify who imports their product or offers their product for import.

Do you have any importer or Amazon is importing it!
 
#4
Important: Foreign facilities must identify who imports their product or offers their product for import.

Do you have any importer or Amazon is importing it!

Hi Monoj,

Thanks very much for taking the time to answer my query.
We do not have any importer. The goods would leave our factory in the UK and arrive in Amazon FBA warehouse in the US.

Many thanks,
Jon
 
Thread starter Similar threads Forum Replies Date
S New Foreign Exporter Looking 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 0
Y When to Sign up as a Foreign Exporter? US Food and Drug Administration (FDA) 8
J 21CFR820 requirements for Foreign Exporter? US Food and Drug Administration (FDA) 4
supadrai Establishment registered as specification developer and foreign exporter only 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
M Foreign Exporter Establishment registration Other US Medical Device Regulations 2
J Establishment registration FDA 'Foreign exporter' 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
S Certificate to Foreign Government (CFG) - who is an Exporter ? US Food and Drug Administration (FDA) 2
W Is Foreign Exporter required to submit a 510(k)? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
E Contract manufacturer FDA requirements foreign company US Food and Drug Administration (FDA) 6
J FDA Establishment Registration Foreign Manufacturer RUO only 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
D What foreign language proficiency would give the biggest edge to medical device regulatory affairs professionals in the world today or in future? Career and Occupation Discussions 6
C What if the foreign manufacturer of a medical device changes the Authorized Representative in Saudi Arabia? Other Medical Device Regulations World-Wide 0
K CFG (certificate of foreign government) Requestor Other US Medical Device Regulations 0
M Strategy for Foreign Regulatory Compliance Other Medical Device Regulations World-Wide 5
S Foreign Manufacturer and DMR - Who keeps the DMR (Device Master Record)? ISO 13485:2016 - Medical Device Quality Management Systems 2
C Attestation of QA certificate from foreign (EU) Notified Body Other Medical Device Regulations World-Wide 6
I Japanese medical device recall requirements & procedure for foreign manufacturers Japan Medical Device Regulations 4
M Can a foreign manufacturer sell directly to US customers? Other US Medical Device Regulations 4
V Own foreign manufacturing facilities declared as sub-contractors ISO 13485:2016 - Medical Device Quality Management Systems 5
K FOD (Foreign Objects and Debris) - AS9100 & Hook Assemblies AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 11
S Calibration and Verification requirement for foreign EASA Part 145 EASA and JAA Aviation Standards and Requirements 7
S Registration/Listing; Initial Importer - Private Label w/ Foreign Establishment 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 7
F Scientific and Research Papers for Foreign Approved Devices Other US Medical Device Regulations 1
M Difficulties Controlling Foreign Suppliers Supplier Quality Assurance and other Supplier Issues 8
Q Medical Device Establishment Registration/Listing for Foreign Private Labeler Other US Medical Device Regulations 8
S AS9100 FOD (Foreign Objects and Debris) Requirements AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 10
Y FDA's Inspection Frequency for Foreign Manufacturer Other US Medical Device Regulations 1
E FDA guidance on Foreign establishment registration US Food and Drug Administration (FDA) 3
B Health Canada Acceptance Policy of Foreign Clinical Trial Data for Devices Canada Medical Device Regulations 2
Pancho "IRS" Request for recertification of foreign status [SCAM] After Work and Weekend Discussion Topics 6
M Eligible to obtain certificate of foreign government (CFG) Other Medical Device Regulations World-Wide 15
S Becoming an In Country Entity in Foreign Countries Other Medical Device and Orthopedic Related Topics 1
U Do we have to have foreign legal documents? (ISO13485 4.2.3 document control) ISO 13485:2016 - Medical Device Quality Management Systems 3
E Obligations of Foreign Distributors of US Medical Devices US Food and Drug Administration (FDA) 1
WCHorn ITAR for waiver/exemption for Foreign Persons AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 10
K Certificate of Foreign Government (Distributor in Mexico) 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
AnaMariaVR2 ANVISA Considers Accepting Foreign GMP Certifications US Food and Drug Administration (FDA) 0
S Renewal of "Accreditation Certificate of Foreign Medical Device Manufacturer" Japan Medical Device Regulations 3
I Foreign Medical Device Manufacturer Complaint File Establishment US Food and Drug Administration (FDA) 2
F When TSA stop to issue new Foreign FAA Part 145 Repair Station? Federal Aviation Administration (FAA) Standards and Requirements 1
N Foreign Manufacturer requesting FDA's CFG over their country's FSC 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 11
Z Submission of foreign data without IRB approval Other US Medical Device Regulations 2
Z Foreign Manufacturer selling in the US - Postmarket Surveillance question Other US Medical Device Regulations 2
S FOD (Foreign Objects and Debris) and AS9100 compliance AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
H Medical Device Vendor (Supplier) Audits - Foreign Languages and Translations General Auditing Discussions 7
G Country of Origin Medical Labeling - Foreign Content, Domestic Assembly Other US Medical Device Regulations 3
S Bringing a Medical Device Sample from a Foreign Country into the US 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 6
K How to Communicate to Operators (Especially Foreign Workers) - Language Issues Misc. Quality Assurance and Business Systems Related Topics 11
R Transfer of a Medical Device 510k to a Foreign Company US Food and Drug Administration (FDA) 20
X Foreign Manufacturer Accreditation Certificate Applicability Japan Medical Device Regulations 8

Similar threads

Top Bottom