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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.