A market-by-market breakdown of language compliance requirements: EU CE, FDA, NMPA, Japan PMDA, Korea MFDS, and Middle East regulatory language requirements.
- Why we are not publishing a dated list
- What each entry needs
- Tie it to your own change events
Why we are not publishing a dated list
Language obligations and their deadlines change, and they differ by product class, pathway and market. A dated table published here would be wrong for some readers on the day it went up and wrong for everyone eventually.
What follows is how to build and maintain your own calendar, verified against your notified body and regulatory consultants. Treat any general list — including any you find elsewhere — as a prompt to verify, not as an authority.
What each entry needs
For every market and product class: which documents must be in the local language, which languages count as acceptable, what triggers a re-translation obligation, and who verified it and when.
That last field is the one teams omit and the one that matters most. A requirement with no verification date is indistinguishable from a guess after a year.
Tie it to your own change events
Most language obligations are triggered by your actions rather than by a date: entering a market, changing labelling, revising an IFU, adding a variant. Build the calendar around those events and the review cadence follows naturally.
Then set a fixed re-verification interval — annually at minimum, and immediately on any regulatory change affecting your class.