UDI Registration - Who is responsible for Registration of the Device?

fialor

Involved In Discussions
#1
Hello All,
Hopefully everyone is staying safe.

I have a client who distributes a product in the US with the labelling "manufactured for" and contractually is "...product for distribution in the territory..".
Will the client have to comply with UDI or is it the company which "manufactures for" my client who have to register in GUDID and provide a the UDI including the company GTIN.
Thank you
 
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monoj mon

Involved In Discussions
#2
Either way is fine, provided specially the following information are present in the GUDID Database besides are required information:

1. DUNS number of the responsible company who is providing their GTIN containing their own Company Prefix to the GUDID Database
2. GTINs should match with the DIs on the product labels
3. Brand Name of the Product

Usually the Brand Owner/Manufacturer places their GTINs on the label and fulfill the GUDID criteria, but it depends on the contract between the two companies.
 
Last edited:

Ajit Basrur

Staff member
Admin
#3
Hello All,
Hopefully everyone is staying safe.

I have a client who distributes a product in the US with the labelling "manufactured for" and contractually is "...product for distribution in the territory..".
Will the client have to comply with UDI or is it the company which "manufactures for" my client who have to register in GUDID and provide a the UDI including the company GTIN.
Thank you
The UDI Rule specifies that the labeler, as defined under 21 CFR 801.3, is responsible for complying with the UDI labeling (21 CFR 801 Subpart B) and GUDID submission (21 CFR 830 Subpart E) requirements.
 

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fialor

Involved In Discussions
#4
Thanks Ajit.

In plain language, my client whose name appears on the label as "manufactured for..." must register in GUDID and provide the DI for the product they distribute?
 

fialor

Involved In Discussions
#5
Thanks Monoj.
My concern is that there would be multiple DIs for what is essentially the same product. Of course with different GTINs.
 

monoj mon

Involved In Discussions
#7
Thanks Monoj.
My concern is that there would be multiple DIs for what is essentially the same product. Of course with different GTINs.
Hi Fialor,

Somehow I missed to reply to your question, sorry for that.

I assume by saying "Multiple DIs for the same product" you mean that both the parties (the "manufactured by" and "manufactured for") are assigning DIs on their own and registering in the GUDID database for the same product they are dealing with! If that so, then I am afraid this is not necessary and at some point this is wrong. Only one party (who falls under the FDA's definition of "labeler") has to take the responsibility and the other party shall refrain from registering the same product in the database. In your case if the company ("Manufactured By") is the "labeler" and selling the same product to different distributors (including your client) then, to make things simple, they should provide their own DIs on the labels as well as to the database unless,

1. there is no change in the "Brand Name" for different distributors
2. there is no change in the "Version or Model" for different distributors
3. there is no change in the "device count" for different distributors at any given packaging level (except the shipping containers or the pallets)

The above three points are the basic elements, from distribution perspective, which trigger "New DIs" for the product on their labels. You can check this list from FDA (attached file). So, if your client is responsible to make significant changes with the device in order to modify the labeling (except adding their company name and address which is not considered as the significant change) which trigger new DI then, of course, your client shall generate new DIs and assign it on the labels as well as provide to the GUDID database. In that case, "YES" there will be different "DIs" for literally the same product but now this is acceptable as it falls under the above "New DI Trigger" concept.

On the other hand, by saying "Multiple DIs for the same product" if you mean that different DIs at different packaging level then I would say that this is normal and this is the basic idea behind implementation of the DIs.

there would be multiple DIs for what is essentially the same product. Of course with different GTINs.
By the way, "DI" and "GTIN" are the same thing, except "DI" is the official term from the FDA whereas GTIN is the official term from the GS1.
 

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MDRexpert

Involved In Discussions
#8
Hello Everyone,

So we have registered to GS1 and have a prefix cert. Can someone describe what is the next step?
Once we can start creating UDI's we then register to GUDID? Can some share if they have a system in place for UDI system?
Once we have registered to UDI what are the next steps to track or maintain them?

Any suggestion/help is appreciated. Thank you!
 

monoj mon

Involved In Discussions
#9
Hello Everyone,

So we have registered to GS1 and have a prefix cert. Can someone describe what is the next step?
Once we can start creating UDI's we then register to GUDID? Can some share if they have a system in place for UDI system?
Once we have registered to UDI what are the next steps to track or maintain them?

Any suggestion/help is appreciated. Thank you!
The next step is to creat and register your GTINs in the GS1 database itself. After that register them in the GUDID database, it will take around one month to publish your DIs(or GTINs).
 

MDRexpert

Involved In Discussions
#10
The next step is to creat and register your GTINs in the GS1 database itself. After that register them in the GUDID database, it will take around one month to publish your DIs(or GTINs).
Thank you so much for a quick response! We have our UDI's ready and now ready to register them in GUDID database?
Why does it take a month to publish DI's in GUDID database?
 
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