Design Control for Relabeling and Repackaging

A

Alexlefei

#1
#1
I want to know what design control we need to have if we just relabel an outsourced product into our own brand.

We are an IVD manufacturer and we are planning to add a few new products into our catalog. We have found some potential vendors. What we do is we purchase these tests from the vendors and relabel them into our own brand.

I know that we are considered to be manufacturer. But I am not sure what design control we should have in place to fulfill different regulation requirements.
 
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Ronen E

Ronen E

Problem Solver
Staff member
Moderator
#2
#2
Hello and welcome to the Cove :bigwave:

Are those tests already cleared for US distribution, before you relabel them?

Someone has to be responsible for the design of those devices. If they are already cleared, you are only responsible for the new labeling (if that includes a modified intended use, I would say that it includes some design responsibility). If you are the first to clear them under US regulation, it doesn't matter that practically you are only relabeling. In my opinion in the latter scenario you'd also be responsible for the design. Regulatory responsibility for the design entails a requirement for some level of design control.

This is my general view, without knowing the actual classification and other specifics.

Cheers,
Ronen.
 
S

sreenu927

Quite Involved in Discussions
#3
#3
Hi..It all depends on the market you would like to enter. It seems, for US, this strategy is called as "Private Labeling" or "Private branded products", where by the design, manufacture and regulatory pathway is owned by your vendor. You will be the importer and distributor of the product under your own brand.
It will be entirely a different scenario if it is EU and APAC. There is no such concept of private label in these regions.
You have to be a legal manufacturer or a distributor with co-branding strategy.

Regards,
Sreenu
 
A

Alexlefei

#4
#4
sreenu927 said:
Hi..It all depends on the market you would like to enter. It seems, for US, this strategy is called as "Private Labeling" or "Private branded products", where by the design, manufacture and regulatory pathway is owned by your vendor. You will be the importer and distributor of the product under your own brand.
It will be entirely a different scenario if it is EU and APAC. There is no such concept of private label in these regions.
You have to be a legal manufacturer or a distributor with co-branding strategy.

Regards,
Sreenu
Click to expand...
I think I have got the answer. As long as you label it into your own company's brand name, you are responsible for design control of the product, at least to some extent.
 
A

Alexlefei

#5
#5
Ronen E said:
Hello and welcome to the Cove :bigwave:

Are those tests already cleared for US distribution, before you relabel them?

Someone has to be responsible for the design of those devices. If they are already cleared, you are only responsible for the new labeling (if that includes a modified intended use, I would say that it includes some design responsibility). If you are the first to clear them under US regulation, it doesn't matter that practically you are only relabeling. In my opinion in the latter scenario you'd also be responsible for the design. Regulatory responsibility for the design entails a requirement for some level of design control.

This is my general view, without knowing the actual classification and other specifics.

Cheers,
Ronen.
Click to expand...
Yes, the tests are cleared for distribution under the vendor's brand name.
 
Q

QA-Man

#6
#6
Alexlefei said:
I want to know what design control we need to have if we just relabel an outsourced product into our own brand.

We are an IVD manufacturer and we are planning to add a few new products into our catalog. We have found some potential vendors. What we do is we purchase these tests from the vendors and relabel them into our own brand.

I know that we are considered to be manufacturer. But I am not sure what design control we should have in place to fulfill different regulation requirements.
Click to expand...
You would be developing labeling specifications, packaging specifications (your shipping box), manufacturing work instructions (relabeling instructions), etc. You might even do some risk management and discover you want the IFU to give a little more info. Even though you're not designing the "core" product there are still some design activities going on.
 
Ronen E

Ronen E

Problem Solver
Staff member
Moderator
#7
#7
QA-Man said:
You would be developing labeling specifications, packaging specifications (your shipping box), manufacturing work instructions (relabeling instructions), etc. You might even do some risk management and discover you want the IFU to give a little more info. Even though you're not designing the "core" product there are still some design activities going on.
Click to expand...
I wouldn't necessarily assume all that. To me it sounds more like a straightforward private label case, where the only differences are brand name, address and the like, and there is no physical relabeling because the OEM manufactures the devices (including packaging and labeling) with the private label upfront. I'm not even sure that "relabeling" is the accurate classification of that set-up.

Hopefully the OP will clarify.

If your assumptions are correct (ie there are changes in packaging, IFU etc.) then I agree that there is some design going on and therefore design control is required.
 
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