OEM / OBL "Private labeler" agreement template?

[pbojsen]

My company, located in the US, is a private label manufacturer of dental care devices. We own the design of the devices, and sell to customers such as Walmart, Target, etc. with their labels.

We also sell to customers in the EU. However, in the EU the private labeler is considered the manufacturer, even though they are not truly the manufacturer. They do not own the design, we do.

I have read that there are template agreements between OEMs and EU "own brand" or "private label" customers, and was wondering if anyone knew where I can get my hands on such a template. Any help with this is greatly appreciated!

 

[Pancho]

Google said this might help (not free, tho): Technical quality agreement for contract manufacturing.

 

[Charlotte Percy]

On pages 6 and 7 of the attached EK MED document 3.9 B 16 there is a list of the items to take care of in the contract. These are the items that the German ZLG is asking notified bodies to look for in these sorts of agreements. Hope this helps.

Charlotte

 

[somashekar]

My company, located in the US, is a private label manufacturer of dental care devices. We own the design of the devices, and sell to customers such as Walmart, Target, etc. with their labels.

We also sell to customers in the EU. However, in the EU the private labeler is considered the manufacturer, even though they are not truly the manufacturer. They do not own the design, we do.

I have read that there are template agreements between OEMs and EU "own brand" or "private label" customers, and was wondering if anyone knew where I can get my hands on such a template. Any help with this is greatly appreciated!

OBL agreement typical ...see here and you may consult and modify accordingly.
Let this agreement be a standalone agreeement and not clash with any other commercial agreements that are established between the two parties ...
good luck.

 

[pbojsen]

Thanks, all. This is very helpful info!

 

[solidblack]

We want to import inflation device from china to India on OEM basis. Then we want to relabel/repack it with our own brand name. So what is the regulatory requirements for CE marking of our own branded inflation device. Please shade light on this confused issue. Any help will be highly appreciated.

 

[somashekar]

Welcome to the Elsmar Cove Solidblack ~~~

We want to import inflation device from china to India on OEM basis.

IMPORT IT

Then we want to relabel/repack it with our own brand name.

RELABEL / REPACK IT

So what is the regulatory requirements for CE marking of our own branded inflation device.

CE MARK IS NOT A REGULATORY REQUIREMENT IN INDIA

Please shade light on this confused issue. Any help will be highly appreciated.

When you see THIS page you will know that your product is not considered a medical device requiring license for importing.

 

[solidblack]

Thank you very much for your response. After relabeling and repacking of the OEM product, we want to sell our product domestically (India) as well as in Overseas (Europien countries) market also. So what is the regulatory requirement for the relabeling /repacking of OEM product with our own brand name & selling distributing the same in various Europien countries including domestic market. Is there any specific guidelines? Please kindly give your valuable inputs.........


Many many thanks..............................................

 

[somashekar]

Thank you very much for your response. After relabeling and repacking of the OEM product, we want to sell our product domestically (India) as well as in Overseas (Europien countries) market also. So what is the regulatory requirement for the relabeling /repacking of OEM product with our own brand name & selling distributing the same in various Europien countries including domestic market. Is there any specific guidelines? Please kindly give your valuable inputs.........


Many many thanks..............................................

Discuss with your OEM if you and he can enter into an OBL business agreement.
As far as possible, work with his notified body for the OBL CE, which is fairly simple when you see the various posts and attachments in this thread.
Appoint an EU rep since your will be the manufacturer per the product label and you are not in Europe. (Again as far as possible have the same EU rep as your OEM's since he is also out of Europe)
CE mark your product and place it in the EU market.
Remember, if your OEM does not maintain his CE through his various processes, your CE stands effected as they will be linked and will have the same validity dates.
Also see similar discussion threads down this page >>>

 

[Jagoda]

Insufficient data to answer you exactly? Which class is this product? Does the article require certification by a Notified Body? Is the Chinese manufacturer has exported goods to the Union under their own or other brand?