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Establishment Registration

#1
Hello,

We are a non-US based company. We plan to purchase class 2 medical devices from a manufacturer to distribute in the US.

The manufacturer does not want to register with the FDA if possible. Can we register our company as a manufacturer with the FDA (taking legal responsibility) and label the product as 'manufactured for'?

Any other way possible solution for us to be able to purchase and distribute the medical devices in the US without registering the manufacturer?
 
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William55401

Quite Involved in Discussions
#2
I would proceed with caution. Why doesn't the mfr want to register? Do they believe they would not be in substantial compliance to US FDA requirements? Even IF you could take responsibility, these two questions must be answered.

I do not think you can register as the mfr if you do not legally own the manufacturing entity. Part of the registration includes an owner / operator section. Here's an URL of the database. Establishment Registration & Device Listing

Devices sold in the US must comply with QSRs. Registration and listing is how FDA becomes aware of your org and product(s). Your work around proposing no registration is not viable.

Can you find another source that is already registered and listed? Class II products should have competition and you should be able to source elsewhere. An organization's quality system is an important part of ensuring continuity of supply. Don't just look at the product. Look at the QMS behind the product as part of your overall selection of who to partner with.
 

monoj mon

Quite Involved in Discussions
#3
The manufacturer does not want to register with the FDA if possible. Can we register our company as a manufacturer with the FDA (taking legal responsibility) and label the product as 'manufactured for'?
It is impossible for the "contract manufacturer" to avoid registering their facility and listing the device, until and unless, you get the components from them and assemble/manufacture the "finished device" at your facility. But, I don't know you would like to do it or not as it may cost you a huge amount of money, men power and time. So, as William has stated, the cheapest option for you is to change the "Contract Manufacturer".
 

Ajit Basrur

Staff member
Admin
#4
Hello,

We are a non-US based company. We plan to purchase class 2 medical devices from a manufacturer to distribute in the US.

The manufacturer does not want to register with the FDA if possible. Can we register our company as a manufacturer with the FDA (taking legal responsibility) and label the product as 'manufactured for'?

Any other way possible solution for us to be able to purchase and distribute the medical devices in the US without registering the manufacturer?
Not if the Contract Manufacturer is making a "finished" medical device.
 
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