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
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