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Change Notifications and Updates

Changes requiring MAH licence amendment​

The following changes to the MAH's circumstances require notification to or authorisation from the licensing authority before the change is implemented:

  • Change of Responsible Technical Officer — the incoming RTO must meet qualification requirements; notification filed with licensing authority
  • Change of principal office address — notification to licensing authority required; may require new licence issuance if the new address is in a different prefecture
  • Change in device classes covered — if the MAH wishes to add higher-risk device classes, an amended or new licence may be required
  • Corporate changes — mergers, acquisitions, or changes in the legal entity holding the licence require MHLW/prefectural guidance

Changes requiring notification only​

  • Change in business name — notification filed with licensing authority; no approval required
  • Change in contact person (non-RTO) — notification as required by the licensing authority's administrative procedures

Process and timelines​

Notification to the prefectural government or MHLW is typically a straightforward administrative process completed within a few weeks. Changes that require amendment of the licence itself (rather than mere notification) may take 1–2 months.

Keep detailed records of all change notifications filed — these records are reviewed during PMDA QMS inspections as evidence of good regulatory practice.

Notification must be submitted to the licensing authority before the change is implemented. Changes implemented without prior notification or approval may result in regulatory action or licence suspension.