FDA Registration for Sub-contract manufacturers

JoCam

Trusted Information Resource
#1
Hi All,

A European medical device manufacturer uses a European sub-contract manufacturer to make and assemble their medical devices for them, including affixing the manufacturers labels. The sub-contract manufacturer then ships the product directly to the manufacturer, who distributes these devices across North America as the legal manufacturer. The medical device manufacturer has a US Agent and is FDA registered. Does the sub-contract manufacturer also need to be FDA registered?

JoCam
 
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mihzago

Trusted Information Resource
#3
If your contract manufacturer ships you a finished and packed device ready to be supplied to a customer, and all you do is distribute, then they are a "Contract Manufacturer" and have to register and list.

If they send you devices that are not fully finished and you perform some activities before distributing to customers, then it's possible they could be considered only a sub-contractor and not having to register.

Registration is fairly quick and easy, but I guess $5k/ year stings a bit.
 
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