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
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
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
S Taiwan QSD application Other Medical Device Regulations World-Wide 1
V Taiwan - Veterinary medical devices Other Medical Device Regulations World-Wide 1
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 3
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 6
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
S Pros and cons to transition to AS9100 for non aerospace company AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 7
L ISO13485:2016 and Subsidiary Company ISO 13485:2016 - Medical Device Quality Management Systems 4
M Does any one know if company is allowed to submit appeal for rejected registration file Other Medical Device Related Standards 0
T Company AS9100D External Audit Preparation AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 17
E Device compatibility with other company's devices US Food and Drug Administration (FDA) 0
M An interesting question about import company Other Medical Device Regulations World-Wide 5
T ISO9001:2015 for Work-from-home company ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 48
M Role of Quality Manager in a manufacturing company AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 12
R How many process maps are adequate for a company for IATF 16949? Process Maps, Process Mapping and Turtle Diagrams 17
M Questions concerning QMS and/or company specific nonconformance Customer Complaints 2
Aliken Recommendation for the ISO 13485 certification company ISO 13485:2016 - Medical Device Quality Management Systems 7
C ISO Cert and Parent Company is not Certified ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
H Product Safety & Conformity Representative (PSCR) Training Company IATF 16949 - Automotive Quality Systems Standard 0
Q Training Machinists on Company Processes Training - Internal, External, Online and Distance Learning 6
C Regulatory Affairs in a start-up medical device company Career and Occupation Discussions 1
Q Approving distributors as suppliers for automotive company Supplier Quality Assurance and other Supplier Issues 1
P How to keep a ISO 9001:2015 certification when a company is sold ? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
cgaro62 Does FDA apply to a non-medical 13485 certified custom manufacturing company? ISO 13485:2016 - Medical Device Quality Management Systems 11
M New Daughter company - ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
T Accreditations as part of 9001 - Quality checks on your company ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
L BlipSnip is it Legit Company? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
M Seeking Consultant for Orthopedic Start Up company Other Medical Device and Orthopedic Related Topics 1
R Can PLM be in the OEM position for another company? EU Medical Device Regulations 1
L Acquiring software from 3rd party company IEC 62304 - Medical Device Software Life Cycle Processes 8
T Does marketing company require CE mark if manufacturer has CE mark on product? EU Medical Device Regulations 5
H Starting my own 3rd party inspection company Service Industry Specific Topics 6
Kevin_Hall Becoming a successful manager of a spacecraft company Human Factors and Ergonomics in Engineering 11
Ed Panek Which choice of the following most closely matches the MDR compliance of your company? EU Medical Device Regulations 0
J How many majors is one company allowed ? IATF16949 Manufacturing and Related Processes 16
A Outsourcing registration to a local company China Medical Device Regulations 1
D Technical Standard aggregator company suggestions AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
R Transferring a calibrated counting scale to a sister company Calibration Frequency (Interval) 2

Similar threads

Top Bottom