Re: Translation Requirements on Medical Device Packaging Labels
The regulatorily critical labeling is that which is available to the end user as near as possible to the location and time of use. For a sterile OR product, that's the pouch label.
Generally for such products, the box label is considered to be equally important because product distribution external to and within use facilities affects its availability for use, and critical activities such as recalls may be implemented with respect to box labels in the case of not-yet-shelved inventory.
So: if translation is required, it's required for both pouch and box labels. This is industry standard, in my experience, and applicable across all regulatory systems.