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Dual-Language Labelling Rules

JP-unique

Japanese law requires core labelling in Japanese for all devices marketed in Japan. This creates practical challenges for global manufacturers using common labelling across multiple markets, particularly for devices that carry EU MDR / FDA labels not formatted for the Japanese mandatory elements.

Which elements must be in Japanese​

The following elements must appear in Japanese on labels and IFU for devices marketed in Japan:

  • All mandatory label elements listed in the Labelling Ordinance (see Japanese Labelling Requirements)
  • Warnings and precautions — must be in Japanese to ensure healthcare providers and patients understand them
  • Instructions for use — must be in Japanese

Acceptable formats for imported devices​

MHLW allows several practical approaches for managing international labelling:

Japanese oversticker. A Japanese-language sticker applied over or alongside the original manufacturer label, containing all mandatory Japanese elements. Widely used for devices where the carton has space.

Japanese label addendum. A separate Japanese-language label applied to the device packaging (e.g. inner or outer carton) in addition to the original language label.

Full Japanese-language label replacement. The entire label is reprinted in Japanese (and English if desired). Required for devices where space or format constraints make overstickers impractical.

Japanese-language insert. For IFU, a Japanese-language insert (package insert) placed inside the packaging alongside the original language IFU is acceptable where MHLW has accepted this approach for the device type.

Practical tips​

  • Include the Japanese MAH address and MAH business name (as registered with MHLW) on the primary label or prominent position on packaging — MHLW inspectors verify this information against the approval record. If the MAH address or name on the label does not match the MHLW records, the device may be considered non-compliant.
  • Confirm approval/certification number format with your MAH before printing
  • Approval/certification numbers change if the approval is transferred to a new MAH — all printed labels bearing the old MAH name and approval number cannot be used. Plan inventory carefully and coordinate labelling reprinting with the transfer approval timeline to avoid stock obsolescence.
  • Plan labelling change timelines carefully — Ichibu Henko may be required for certain label changes

Electronic IFU considerations​

See Electronic IFU for Japan's current position on eIFU acceptance.

Japanese text on labels and IFU must be clearly legible and of sufficient prominence to meet the intent of the Labelling Ordinance. While specific minimum font sizes are not uniformly mandated across all device types, the Japanese text should not be subordinated in visual hierarchy to the original language text. Consult PMDA guidance for your specific device type regarding visual hierarchy and legibility requirements.