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Overview — What is Todokede?

JP-unique

Todokede (届出) is Japan's pre-market notification pathway for Class I (general) medical devices. It is filed with the prefectural government — not with PMDA or MHLW — and does not involve scientific review. Despite its simplicity, it is a legal prerequisite for placing Class I devices on the Japanese market.

What Todokede authorises​

A Todokede notification acknowledges that the MAH has notified the prefectural government of its intent to market the described Class I device. Following acknowledgement, the MAH may begin commercial sales in Japan.

Unlike Shonin (which gives the MAH a numbered approval certificate) or Ninsho (which gives a numbered certification), Todokede results in a notification reference number. The device is not "approved" in the Japanese regulatory sense — it has been "notified."

Which devices use Todokede​

All Class I (general) medical devices require a Todokede notification before marketing. Class I devices are the lowest-risk category — examples include non-sterile examination gloves, tongue depressors, bandages, and basic examination furniture.

There is no scientific review and no assessment of safety or efficacy by any government body as part of the Todokede process. The MAH bears full responsibility for ensuring the Class I device is safe and conforms to applicable standards.

Where to file — prefectural government​

Todokede notifications are filed with the prefectural government of the prefecture in which the MAH's principal office is located. For MAHs with offices in Tokyo (the most common location), this is the Tokyo Metropolitan Government Health and Welfare Bureau (東京都福祉保健局).

Each prefecture has its own administrative process and forms. MHLW provides a standard notification format that prefectures follow, but minor variations in procedure exist.

MAH obligations for Class I devices​

Despite the simplified pre-market process:

  • The MAH must hold a valid MAH business licence
  • The device must comply with PMD Act labelling requirements
  • Adverse events must be reported to MHLW where required
  • QMS requirements under MO 169 still apply (lighter requirements than for Class II–IV)
  • If a safety issue requires a recall, the MAH must notify MHLW