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Voluntary Licence Surrender and Transfer

Surrendering an MAH licence​

If an MAH wishes to cease operations and surrender its licence, it must:

  1. Notify MHLW and the relevant prefectural government of the intention to surrender
  2. Resolve all outstanding regulatory obligations (pending adverse event reports, re-examination obligations, open FSCAs)
  3. Transfer all held Shonin approvals and Ninsho certifications to a new MAH before surrender — approvals cannot simply be abandoned with devices still in the market
  4. File the formal surrender with the licensing authority

Effect on held approvals​

Surrendering an MAH licence without transferring the approvals to a new MAH would result in the approvals lapsing. This is an extreme action with significant consequences for patients relying on the device. MHLW expects MAHs to plan orderly transitions.

Transferring approvals to a new MAH​

When the relationship between an overseas manufacturer and its Kannin MAH ends — or when the manufacturer establishes its own Japan entity — the approvals must be transferred to the new MAH.

Transfer process:

  1. Both current and incoming MAH agree on transfer terms (contractually and regulatorily)
  2. Transfer application filed with MHLW (for Shonin) or the RCB (for Ninsho)
  3. MHLW or RCB issues an amended approval in the incoming MAH's name
  4. Labelling must be updated to show the new MAH name (labelling change notification or Ichibu Henko as appropriate)

Allow 3–6 months for transfer approval, and manage the transition so there is no gap in MAH coverage.