Establishment Registration

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?

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.

MAS biotech said:

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'?

Click to expand...

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".

MAS biotech said:

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?

Click to expand...

Not if the Contract Manufacturer is making a "finished" medical device.

Hi Team,

I 'm from Pharmaceutical background and need some guidance regarding establishment registration and device listing .
Suppose, we are non-US foreign manufacturer having own establishment registration and device listing for own product .Now we are going to do contract manufacturing for US manufacturing company for their products having 510k. So, question is that is it mandatory to do separate establishment registration and device listing for my organisation (as a contract manufacturer) or shall we update our existing establishment registration details to address contract manufacturer . If so, can we a list their device under the same establishment. Please help me out in this situation.
Thanks in advance

Haresh said:

Hi Team,

I 'm from Pharmaceutical background and need some guidance regarding establishment registration and device listing .
Suppose, we are non-US foreign manufacturer having own establishment registration and device listing for own product .Now we are going to do contract manufacturing for US manufacturing company for their products having 510k. So, question is that is it mandatory to do separate establishment registration and device listing for my organisation (as a contract manufacturer) or shall we update our existing establishment registration details to address contract manufacturer . If so, can we a list their device under the same establishment. Please help me out in this situation.
Thanks in advance

Click to expand...

You will update your own listings to include the contract manufactured product. You don't need a separate listing.
In the DRLM system, you will create a new listing with their 510k number and the applicable product code. You'll indicate that your facility is responsible for Contract Manufacturing. The manufacturer will list themselves as Specification Developer.

If you do not have an Establishment Registration, you need to register as a "Contract Manufacturer" and yes, device listing as mentioned by EmiliaBedelia.

Also remember that only finished medical devices and accessories (not components) require Registration and Listing.

EmiliaBedelia said:

You will update your own listings to include the contract manufactured product. You don't need a separate listing.
In the DRLM system, you will create a new listing with their 510k number and the applicable product code. You'll indicate that your facility is responsible for Contract Manufacturing. The manufacturer will list themselves as Specification Developer.

Click to expand...

Thanks a lot for quick response.Your response highly appreciated.

Ajit Basrur said:

If you do not have an Establishment Registration, you need to register as a "Contract Manufacturer" and yes, device listing as mentioned by EmiliaBedelia.

Also remember that only finished medical devices and accessories (not components) require Registration and Listing.

Click to expand...

Thanks Ajit for your valuable input.
Sorry but one more question I have as below:
We will manufacturing the instruments as per their specifications.The final labelling n packaging will be done by OEM at US.So, please confirm me can we consider it as finished Device.If yes, then we need to update our establishment registration to include contract manufacture .Is that correct ?
and do device listing as Emilia recommended.Do we need to pay separate fees for additional contract manufacturer.
Thanks in advance

Refer to the definition in CFR 820.3 - CFR - Code of Federal Regulations Title 21
Finished device means any device or accessory to any device that is suitable for use or capable of functioning, whether or not it is packaged, labeled, or sterilized.

So if the manufacturer is ONLY packaging the device and is not doing any other steps, then yes, it is a finished device.

If you already have an establishment registration, you do not need to pay anything extra to add another activity to your listing. It is important to note though that the OEM must register/list their device in DRLM before you can list it.