Does Contract Manufacturer need to issue Food Grade certificate for finished device?

SGquality

Quite Involved in Discussions
#1
In a tricky situation again and back to my Cove -

we "contract manufacture" for an OEM owning the design and specifications and in this capacity would have also performed Biocompatability and other related tests.

The OEM is asking us to provide a "Food Grade Certificate" for the finished device - our stand has been that we use all starting materials per OEM recommendation and instead of the "Food Grade Certificate" for the finished device, we could give a summary letter stating that we use all Food grade materials as starting materials per OEM recommendations.

We also believe since the OEM is responsible for placing the device on the market, they are responsibel for this certificate.

Thought, pls :)
 
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Ronen E

Problem Solver
Staff member
Moderator
#2
Re: Does Contract Manufacturer need to issue Food Grade certificate for finished devi

You are right. The maximum you can provide is certification (CoC) for the materials used.

"Food Grade" is loosely defined. If they require compliance, they should point you to a specific standard / regulation.

Cheers,
Ronen.
 
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