Importers - For the FDA Registration/ Listing, is the CMO the importer?

#1
Good day.
Company XYZ located in EU has their products manufactured in USA. For the FDA Registration/ Listing, is the CMO the importer?
The CMO has to register the product also?
Regards,
Romane
 
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Ajit Basrur

Staff member
Admin
#2
Hello Romane,

In your example,

Company XYZ (in EU) will be Specification Developer;
Contract Manufacturer (in US) will be Contract Manufacturer.

Both these entities have to list their Establishment with the FDA. Once the establishments are registered , the Device Listing has to be completed where the CM must tag their device with the Company XYZ's device listing. Remember the facilities are "registered", while the devices are "listed".

Now, when you say "Importer", I am not clear what you mean. The CMO has to "export" to EU, correct?
 
#3
Hi Ajit.

thank you for the clarifications.

Since the Company XYZ (in EU) have their products manufactured in USA, during establishment registration or product listing (can't remember at which point) when FDA is asking "who is the importer" who should it be?

Technically the product does not have to be imported since it is already in USA. Do we need an importer?

Thanks,
 

Ajit Basrur

Staff member
Admin
#4
Hi Ajit.

thank you for the clarifications.

Since the Company XYZ (in EU) have their products manufactured in USA, during establishment registration or product listing (can't remember at which point) when FDA is asking "who is the importer" who should it be?

Technically the product does not have to be imported since it is already in USA. Do we need an importer?

Thanks,
Sorry for late response - are you referring to "Initial Importer"?
 

monoj mon

Involved In Discussions
#5
FDA is asking "who is the importer" who should it be?
If the products are manufactured in the US, then there is no question of "Importer". When you "List" the device for your facility then check the box for "Develop Specifications But Do Not Manufacture At This Facility". At a subsequent step during "Listing", you check the box for "Product is not yet being imported into the United States OR the establishment is a specification developer that does not ship the product from this location to the United States." Then, I think, you will be good to go.
 

monoj mon

Involved In Discussions
#6
Now, when you say "Importer", I am not clear what you mean. The CMO has to "export" to EU, correct?
I agree with it, if the products are not meant to be sold in the US and are only for export then the contract manufacturer should list the device as 'U. S. manufacturer of export only devices'
 
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