Skip to main content

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 — 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, including adverse event reporting, complaint handling, and post-market surveillance. Do not assume the incoming MAH's obligations begin before formal approval is issued. Plan transfer timelines carefully to avoid gaps in regulatory coverage and maintain continuity of complaint handling during the transition period.

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an MAH decides to permanently discontinue marketing a device in Japan, the approval or certification must be formally withdrawn (返納 — hennō) by notifying MHLW or the RCB.

Before withdrawing an approval:

  • Notify MHLW of the intention to withdraw
  • Communicate with customers — 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  • The MAH's business licence has lapsed or been revoked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.