Regulatory Open Forum

Hi,

Can we have two distributors' names on labels/IFU for US market? Do we also need to mention the initial importer name on the labels?

1. distributor in US
2. distributor for the rest of the world/ EU

Thanks 

Hi Anoop

Assuming this is about medical devices.

There's no US requirement to show the initial importer on the label. There has to be at least one name and address, of manufacturer or distributor. Showing two distributor names and addresses should be harmless in the US. Are both prepared to receive complaints from US customers?

https://www.fda.gov/medical-devices/device-labeling/general-device-labeling-requirements

If you are planning to use the same label for other countries, check their requirements, too.