Class I Exempt medical devices made in Europe imported to the USA

GuSant

Registered
Hello,
A friend of mine manufactures a device class I exempt in Europe, bringing it to the USA soon.
> European Manufacturer, Registered and Listed at the FDA
> Will designate First Importer
> But likely will sell directly to other USA importers, shipping directly from Europe

The questions:
1) Can a European manufacturer, registered and listed, ship to, consign to, and invoice, a USA importer that is not their specifically appointed FDA-registered First Importer?
2) Assuming answer 1) is "yes" does the manufacturer give any form of intervention, participation, commission, obtain permit from, or have the First Importer do the actual importation process? Or the can the First Importer be skipped altogether?

Thank you!
 

Nichole F

Involved In Discussions
You can designate more than one importer, but may only designate one US Agent. If the company does not have a US address, they will require a US Agent.
 

GuSant

Registered
Thanks. I am trying to establish whether the European Manufacturer must send the container only to a company registered as Firt Importe/Distributor
 

GERAI LTD

Registered
Hello,
A friend of mine manufactures a device class I exempt in Europe, bringing it to the USA soon.
> European Manufacturer, Registered and Listed at the FDA
> Will designate First Importer
> But likely will sell directly to other USA importers, shipping directly from Europe

The questions:
1) Can a European manufacturer, registered and listed, ship to, consign to, and invoice, a USA importer that is not their specifically appointed FDA-registered First Importer?
2) Assuming answer 1) is "yes" does the manufacturer give any form of intervention, participation, commission, obtain permit from, or have the First Importer do the actual importation process? Or the can the First Importer be skipped altogether?

Thank you!
This company should create a business arrangement and its own company in the USA.
 

GuSant

Registered
I have been told that any company (buyer) in the USA purchasing a medical device from Europe must be also registered with the FDA as First Importer, even though the European Manufacturer may have already another company registered as First Importer
 

GERAI LTD

Registered
I have been told that any company (buyer) in the USA purchasing a medical device from Europe must be also registered with the FDA as First Importer, even though the European Manufacturer may have already another company registered as First Importer
If you have yours, it will be super simple to arrange all this.
 

Ronen E

Problem Solver
Moderator
The FDA term is "Initial Importer", and I'm not aware of a limitation on number. Any USA-based entity that imports and distributes the device (i.e. is not the end user) becomes an Initial Importer and must register. They are independent of each other, there is no seniority.

Please note that "exempt" Class 1 device is typically exempt from 510k, but the General Controls still apply unless specifically determined for a specific device code. So the European manufacturer will still have to meet some FDA requirements, and the Initial Importer(s) has(ve) a responsibility to ascertain that the applicable requirements are met.

There is no obligation on the foreign manufacturer to have a company branch or the likes on USA soil.
 
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