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Approval Transfer and Voluntary Withdrawal

Transferring an approval to another MAH​

A Shonin approval or Ninsho certification can be transferred from one MAH to another. This occurs when:

  • An overseas manufacturer changes its Japan distribution partner or MAH service provider
  • A Japan subsidiary acquires the MAH role from a third-party service company
  • A corporate acquisition results in the new entity becoming the MAH

The transfer process requires:

  1. Agreement between the current and incoming MAH
  2. Filing a transfer application with MHLW (for Shonin) or the RCB (for Ninsho)
  3. The incoming MAH must hold a valid MAH business licence
  4. MHLW or the RCB issues an amended approval/certification in the name of the new MAH
  5. Labels must be updated to show the new MAH β€” a labelling change notification or Ichibu Henko may be required

Until the transfer is formally approved by MHLW/RCB, the original MAH retains all regulatory obligations. Plan transfer timelines carefully to avoid gaps in coverage.

Voluntary withdrawal of an approval​

If an MAH decides to permanently discontinue marketing a device in Japan, the approval or certification must be formally withdrawn (返納 β€” hennō) by notifying MHLW or the RCB.

Before withdrawing an approval:

  • Notify MHLW of the intention to withdraw
  • Communicate with customers β€” healthcare institutions relying on the device for patient care must be given adequate notice
  • Consider supply obligations to patients currently using the device (particularly for implantables)

After withdrawal:

  • The MAH must continue to fulfil complaint handling and adverse event reporting obligations for devices still in use for a defined period
  • Records must be retained as required

MHLW cancellation​

MHLW may revoke (cancel) a Shonin approval in circumstances including:

  • The MAH's business licence has lapsed or been revoked
  • The MAH has failed to comply with re-examination or other post-approval obligations
  • Safety information has emerged that justifies withdrawal from the market
  • The MAH has made material changes to the device without required approval

Revocation is a serious regulatory action and is published by MHLW.