FDA Registration for Sub-contract manufacturers

JoCam

Trusted Information Resource
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
 

William55401

Quite Involved in Discussions
In my opinion, yes. Suggest you search on "who must register and list". FDA defines Contract Manufacturer - "Manufactures a finished device to another establishment's specifications." These entities must register and list (and pay the fee). Look under the foreign establishment section.

Here's an URL to the source page
Who Must Register, List and Pay the Fee
 
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mihzago

Trusted Information Resource
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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