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Medical Device OEM (Original Equipment Manufacturer) Agreements

P

Pauling

#1
Hi, all,

Our company is OEM manufacturer of medical device, household appliance, and toy.
One of our client requested us to sign back the agreement for the adapter for their medical device. Acturally we purchased the adapter for our supplier and we did not change trade mark to sell to our client.
Here are the questions:
1. When, who and which case need to sign OEM agreement?
2. In our case, we just like an agent, should we sign the agreement or just request our supplier to sign directly?
Any comment will be appreciated!


BR,
Pauling
 
Elsmar Forum Sponsor
M

MIREGMGR

#2
we just like an agent
This is a business relationship question, not one based on regulatory requirements, unless there's more to the relationship and product than you've described.

Do you really think they see you as just an agent, contributing negligibly to their purchasing operations? My guess would be that's not how they see you.

If you're supplying a component that's identifiable as being made by a third party, but your customer continues to want to buy that component from you, they must perceive that there's an aspect of your and their relationship that's to their benefit. Maybe you provide some integrative services by managing several component vendor relationships, or handle inventory, or are better equipped to control the vendor, or something.

The fact that they asked you to enter into an agreement, I'd think, is a pretty clear indication that one of the things they want to more formally control is the service you provide to them, more so than the component you provide per se. As such, if you like doing business with them and the agreement they've proposed is reasonable, you probably should agree to it.
 
K

kabemueller

#3
Here is another aspect.
Do you repackage or relabel the packaging of the part that you supply to the medical device manufacturer? This will also define your role in this.

I agree with the other opinion that as you are the supplier, device manufacturer will want to have you as contract partner. Ask him what aspects are important to him to fulfill his regulatory obligations and, if necessary, pass on any responsibilities to your OEM supplier (in a contract). The least you should have in writing is a basic specification of the part, e.g. dimensions and material(s).

Karen
 
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