Label, IFU & language by country

label ifu: Spanish · submission: Spanish; foreign evidence may need translation/legalization · status: verified official

label ifu: English and French; professional use exceptions and on request rules apply · submission: English or French · status: verified official

label ifu: Chinese; imported device label/IFU includes agent details · submission: Chinese application dossier with permitted foreign originals/translations · status: verified official

label ifu: Spanish · submission: Spanish through Regístrelo · status: verified general

label ifu: Member State specific by patient/professional use and document type · submission: Competent authority/notified body language rules vary · status: member state specific

label ifu: Bahasa Malaysia for home use devices; English permitted for other devices subject to current guidance · submission: English/Bahasa Malaysia according to MeDC@St requirements · status: verified current

label ifu: Spanish required; other languages may be additional · submission: Spanish; translations/legalization as required · status: verified current

label ifu: Chinese on smallest sales unit and Chinese instructions; importer details included · submission: Chinese · status: verified official

label ifu: English and/or Kiswahili; Kiswahili required for home use instructions/labels under cited compendium · submission: English · status: verified official

label ifu: English; devices sold solely in Puerto Rico/territory may use the predominant language under the rule; foreign language labelling triggers complete required content in that language · submission: English · status: verified official