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MHLW Notification for Recalls

JP-unique

Japan requires MAHs to notify MHLW before or immediately upon initiating a recall. The specific process — notification to MHLW's pharmaceutical affairs division and, for certain recalls, direct coordination with PMDA — differs from EU FSCA processes and FDA recall reporting procedures.

When to notify MHLW​

The MAH must notify MHLW: Before initiating the recall, where time permits — ideally MHLW is informed of the planned recall action before or simultaneously with the first customer notification Immediately upon initiating the recall, where the urgency of the situation means customer notification cannot be delayed pending MHLW approval

Required information in the notification​

The MHLW recall notification must include:

  1. MAH name, address, and licence number
  2. Device name, JMDN code, and approval/certification number
  3. Description of the defect or safety issue — what is wrong with the device
  4. Scope of the recall — which lot numbers or serial numbers are affected; how many units
  5. Distribution information — where affected units have been distributed (hospitals, clinics, distributors)
  6. Recall strategy — how the MAH will retrieve or correct the affected devices
  7. Reason for recall classification (Class I, II, or III using the international risk classification)
  8. Timeline for recall execution and verification

MHLW's role during a recall​

After notification:

  • MHLW reviews the recall information and may request additional detail
  • MHLW publishes recall information on its website (major recalls are listed publicly)
  • MHLW may issue a separate public safety communication if the risk is significant
  • MHLW monitors the effectiveness of the recall through the MAH's reports

Recall effectiveness verification​

The MAH must verify that the recall has reached all affected customers and that the required action (return, correction, or quarantine) has been completed. A final effectiveness report is submitted to MHLW when the recall is closed.

Recall classification system

Recalls are classified using the international risk classification system:

  • Class I: Serious adverse health consequences or death is possible
  • Class II: Adverse health consequences or serious adverse health consequences is possible, but is not likely
  • Class III: Adverse health consequences is not likely

The classification must be justified in the MHLW notification based on the severity of the defect and the likelihood of harm. PMDA guidance documents provide decision trees for appropriate classification of specific device issues.