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Electronic IFU Considerations

Japan's position on eIFU​

As of the knowledge date of this reference, Japan has not adopted a general permission for electronic-only Instructions for Use (eIFU) equivalent to EU Regulation 207/2012. Japanese regulations generally require a physical paper IFU to be supplied with devices, particularly for Class II and above.

MHLW has been studying the eIFU question as part of broader digital health regulatory development. Check the latest MHLW notifications for any updates to eIFU policy, as this is an area of active regulatory development.

Current acceptable approaches​

  • Paper IFU (standard) — a Japanese-language paper IFU supplied with every device unit remains the expected standard
  • Supplementary electronic access — MAHs may additionally provide IFU content electronically (e.g. via QR code on label) as a supplement to the paper IFU, but this does not replace the paper version
  • Exceptions — MHLW may grant specific exceptions for device types where paper IFU is impractical (e.g. very small implantables). These require MHLW agreement in advance.

Monitoring for regulatory changes​

Given that eIFU adoption has proceeded in the EU and is under discussion in multiple markets, Japan is expected to formalise an eIFU framework in coming years. Monitor MHLW notifications and PMDA guidance for updates.