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

[lance]

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!

 

[Ronen E]

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]

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?

 

[Ronen E]

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.

 

[lance]

OK, I got it.
Thank you, Ronen!