For non-US manufacturors: Statement of distributor on insert/labelling

[Paul22]

Hi all of you,

As a non-US manufacturer of IVD medical devices my company is planning to distribute one of our products in the US next year. The product will be directly distributed to several distributors all over the US. As an obligation of the FDA I think we have to state the name of a US distributor in the insert/labelling. So this would be a very big document listing all the (yet not all known) distributors. Or do we have to distribute to only one distributor who distributes to all others and state the name of that distributor on the insert/labelling?
Has somebody got a clue?

[Al Rosen]

Originally Posted by Paul22

Hi all of you,

As a non-US manufacturer of IVD medical devices my company is planning to distribute one of our products in the US next year. The product will be directly distributed to several distributors all over the US. As an obligation of the FDA I think we have to state the name of a US distributor in the insert/labelling. So this would be a very big document listing all the (yet not all known) distributors. Or do we have to distribute to only one distributor who distributes to all others and state the name of that distributor on the insert/labelling?
Has somebody got a clue?

You will need a US Agent and will have to register with FDA. You can find more information on this subject on the FDA website.