A Taiwan company want to sell Class I medical device (510(k) exempt) on Amazon, should we register with FDA?

lance

Registered
#1
Dear all,

May I ask our company should register with FDA or not under this situation?

We are a technical-based Taiwan company (Firm A), and we ask a Taiwan GMP manufacturer (Firm B, contract manufacturer) to fabricate medical devices for us.
Firm A wants to sell medical devices (Class I, 510(k) exempt) on Amazon. The Firm B said they only manufacture medical device for Firm A and don't want to enter US market due to some reason. So, Firm A paid FDA registration fee for Firm B and registered them as a manufacturer and contract manufacturer.

Also, Firm A found a US-service company (Firm C) as the initial importer.

If Firm A want to sell medical device on Amazon (through Amazon FBA process), should they need to register as a foreign exporter?
Or Firm A can put their company name on the package ("Distributed by Firm A") as a distributor, and then export medical device directly to Amazon?

Thank you all!
 
Elsmar Forum Sponsor

Ronen E

Problem Solver
Staff member
Moderator
#2
The important issue is that some entity needs to clearly take the regulatory responsibility. Normally it is the entity whose name and address appear on the labeling (under whose name the device is introduced to commerce in the USA). In some (relatively rare) cases the Contract Manufacturer would be responsible while another entity appears on the labeling under the "distributed by..." wording; but in your case the CM has made it clear that this is not their intention. So it defaults to your company and you must register. Since they are registered as a Contract Manufacturer you need to register as a Specification Developer (a type of manufacturer).

I don't understand what "export medical device directly to Amazon" means. Amazon is a distribution channel and has no regulatory or other jurisdiction. You will, in essence, be exporting to the USA.
 

lance

Registered
#3
Thank you Ronen! So basically, if our company's name want to be shown on the package, we should register as a Specification Developer and/or a Foreign exporter.

As for Amazon, we have other products for pets (not medical devices) and we directly shipped the products to the warehouse of Amazon from Taiwan.

I asked US-service company (Firm C) and they said Distributors are not required to register with FDA. I thought we can act as a distributor by labeling "Distributed by our company" and export the medical devices directly to the warehouse of Amazon.

Firm C said the US Customs only need the FDA registration number of manufacturer and initial importer.

If we put the the manufacturer (Firm B) on the package but shipped the product to a US company from Taiwan via Firm A (without FDA registration), is that ok?

Or, we must register with FDA anyway?
1.jpg
 

Ronen E

Problem Solver
Staff member
Moderator
#4
The point is that someone has to take on the role of the Manufacturer (read: take the main regulatory responsibility), regardless of what's on the label. The regulation section you quoted provides some flexibility with regards to the labeling, but it doesn't affect this fact.

Who do you suggest will take this responsibility other than your company?
The CM (B)? No, they clearly said they're not up for it.
C? Amazon? Of course not.

Whatever shipping arrangements you come up with will not change the basic division of responsibility. It works the other way around - first you decide about roles and responsibilities, then you make sure that your shipping arrangements don't violate them or cause any problems in view of the allocated roles and responsibilities. Once roles are allocated, registration is just a technicality that needs to be complied with, based on allocated roles.
 
Thread starter Similar threads Forum Replies Date
U Intended use - Taiwan EU Medical Device Regulations 2
F Guidance in English for PMS requirements for Taiwan Other Medical Device Regulations World-Wide 2
J What are a Taiwanese Medical device subcontractor's legal responsibilities with Taiwan regulations? Other Medical Device Regulations World-Wide 2
B Taiwan Medical Device registration - Production or legal office Other Medical Device Regulations World-Wide 6
J EU CE Mark Validity in Non EU countries - Brazil. Taiwan, China, Japan, Mexico EU Medical Device Regulations 1
C Registration Process for Medical Devices in Taiwan Other Medical Device Regulations World-Wide 11
C Medical Device Registration Process in Taiwan Other Medical Device Regulations World-Wide 6
T Taiwan Medical Device Importation Other Medical Device Regulations World-Wide 3
E Taiwan Medical Device Adverse Event Reporting Other Medical Device Regulations World-Wide 6
I Vigilance SOP that covers Australia, Taiwan, Japan or Brazil wanted Other Medical Device Regulations World-Wide 1
I Taiwan Medical Device Product Approval Process using a Subcontractor Other Medical Device Related Standards 10
S Taiwan GCP for Medical Devices in English Various Other Specifications, Standards, and related Requirements 1
Q Certified Six Sigma Green Belt Training-Taiwan Professional Certifications and Degrees 8
K Does anyone know any CMM resellers in Taiwan? Inspection, Prints (Drawings), Testing, Sampling and Related Topics 5
Ajit Basrur Internet connections snapped - The Taiwan earthquake Coffee Break and Water Cooler Discussions 5
apestate Seeking Information about Working in Taiwan Career and Occupation Discussions 2
E Contract manufacturer FDA requirements foreign company US Food and Drug Administration (FDA) 6
J How much to charge for helping a startup company with initial ISO 13485 certification? Consultants and Consulting 3
J Sister-company providing parts is only ISO 9001 registered IATF 16949 - Automotive Quality Systems Standard 7
D IATF 16949 Requirement for CMMI in a Global Company Elsmar Cove Forum Suggestions, Complaints, Problems and Bug Reports 0
T Help to Suggest name for a new certification and inspection company Coffee Break and Water Cooler Discussions 7
M Address change for a company with CE/ISO13485 EU Medical Device Regulations 2
M IT validation for a paper based MD repair company QMS ISO 13485:2016 - Medical Device Quality Management Systems 6
M QMS for a repair/servicing company ISO 13485:2016 - Medical Device Quality Management Systems 2
C Internal Audits in a tiny Dx Company Internal Auditing 33
T ISO 13485 - 5.5.1 Responsibility and authority - Small Company Independence ISO 13485:2016 - Medical Device Quality Management Systems 13
F Quality manual for trading company ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
L Implementing the PRRC role in a company EU Medical Device Regulations 5
BeaBea ISO 9001 Customer Feedback Methods - What has worked for your company? Service Industry Specific Topics 17
M Customers Request AS9100 certification - Small Company (less than 20 employees) AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 8
U Document Approval - Software company ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
T EQMS for small medical device company ISO 13485:2016 - Medical Device Quality Management Systems 11
qualprod Corona virus Contingency plan - What have you done in your company? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 25
Q Must product name be listed the same name in FURLS, UDI, GUDID and Company Website? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
E Sharepoint for ISO 13485 QMS for small IVD company ISO 13485:2016 - Medical Device Quality Management Systems 7
N Small Company - Internal audit process - Who does the audit? Internal Auditing 16
Z 510(k) usage - Company has 2 physically similar products Medical Device and FDA Regulations and Standards News 2
Q Company Ownership Change ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 13
L Contracted Manufacture Company wanting to be able to design and manufacture own product. 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 7
D ISO9001 for one man company ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
T Client Communication - SaaMD company Misc. Quality Assurance and Business Systems Related Topics 3
R Notified Body for MDD 1Q20 - Florida Company Registrars and Notified Bodies 4
E In need of a new TGA sponsor - Small software company Other Medical Device Regulations World-Wide 4
F ISO 17025 8.8 Internal Audits in a segmented company ISO 17025 related Discussions 5
E Company A supplies pharmaceuticals to the MOI - Who is responsible? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
J Quality Assurance in China - Developing a quality management system for a California company Misc. Quality Assurance and Business Systems Related Topics 7
S How to determine & document Organizational Knowledge of a company Document Control Systems, Procedures, Forms and Templates 4
U IT Process is Taken From company and Added to Corporate Structure ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
G Is ISO 9001:2015 certification worth it for a company that does only contract manufacturing? Quality Management System (QMS) Manuals 14
N Non traumatic edge - Remark in some of my company drawings EU Medical Device Regulations 1

Similar threads

Top Bottom