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Notification Requirements and Process

Required information in the Todokede filing​

The Todokede notification must contain:

  • MAH name and address — must match the MAH's current prefectural business licence
  • Device name — the Japanese product name
  • JMDN code — the assigned Japan Medical Device Nomenclature code
  • Intended use — a brief description of the device's intended use
  • Manufacturing site information — name and address of the manufacturing site(s); FMR number for foreign sites
  • MAH licence number — confirming the MAH holds a valid licence

Unlike a Shonin application, no technical documentation, clinical data, or risk management summary is submitted with a Todokede.

Step-by-step process​

  1. Confirm Class I classification. Verify the JMDN code confirms Class I and that no higher-class designation applies to the specific intended use.

  2. Confirm MAH licence. The MAH must hold a valid MAH business licence issued by the relevant prefectural government (Class I devices — usually a general MAH licence).

  3. Complete FMR (if foreign manufacturer). The manufacturing site FMR reference must be available before filing.

  4. Prepare the notification form. Use the MHLW-prescribed format, available from the prefectural government.

  5. Submit to the prefectural government. Submit in person, by post, or (where permitted by the prefecture) electronically.

  6. Receive acknowledgement. The prefectural government acknowledges the notification and issues a reference number. This typically takes a few days to a few weeks.

  7. Begin marketing. The MAH may begin marketing the device in Japan from the date of acknowledgement.

Changes to a Todokede notification​

If any of the notified information changes — device name, manufacturing site, intended use — the MAH must file a change notification with the same prefectural government. Changes that elevate the device's class (e.g. an expanded intended use that makes the device a Class II) require withdrawal of the Todokede and filing of a new Ninsho or Shonin application.