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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 name on the primary label — MHLW inspectors focus on this
  • Confirm approval/certification number format with your MAH before printing
  • Approval/certification numbers change if you transfer the approval to a new MAH — all printed labels become incorrect
  • 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.