Standards & Translation Requirements
Language requirements for IFUs and labels per country.
| Country | Regulatory Body | IFU Languages | Label Languages |
|---|---|---|---|
| Germany | BfArM | German, English | German |
| France | ANSM | French, English | French |
| Italy | Ministero della Salute | Italian, English | Italian |
| Spain | AEMPS | Spanish, English | Spanish |
| Brazil | ANVISA | Portuguese, English, Spanish | Portuguese |
| Japan | PMDA | Japanese, English | Japanese, English |
| USA | FDA | English | English |
| Canada | Health Canada | English, French | English, French |