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When a Recall is Required

Voluntary vs mandatory recalls​

Japan's PMD Act provides for both voluntary recalls (initiated by the MAH) and MHLW-ordered recalls.

Voluntary recalls are the most common. An MAH initiates a voluntary recall when it determines that a device on the market has a defect, non-conformity, or safety issue that warrants removal or correction. The decision to initiate a voluntary recall is made by the MAH, but MHLW notification is still required.

MHLW-ordered recalls (命令回収 — meirei kaishū) occur when MHLW determines that a device poses a risk to public health and the MAH has not voluntarily initiated appropriate action. MHLW-ordered recalls are rare but represent a significant enforcement tool.

Trigger criteria​

A recall should be considered when:

  • The device has a manufacturing defect — non-conformity with manufacturing specifications
  • The device has a design defect — a systematic safety issue affecting all units of a design
  • The labelling is defective — incorrect, misleading, or insufficient labelling that could lead to unsafe use
  • A contamination issue exists — e.g. non-sterility of a sterile device
  • Post-market data has revealed a safety issue not identified at the time of approval

The MAH should assess whether the issue creates a risk of harm to patients. If there is a realistic possibility of harm, recall action is warranted. When in doubt, PMDA consultation is available.

MHLW notification for recalls​

Before or immediately upon initiating a recall, the MAH must notify MHLW. See MHLW Notification for Recalls for the specific process and requirements.

MAH's role in recall decisions​

The MAH makes the initial decision to recall. In practice, this decision is often made in consultation with:

  • The overseas manufacturer (who typically has detailed knowledge of the technical issue)
  • The MAH's responsible technical officer
  • In complex cases, PMDA consultation

The MAH is responsible for the recall strategy, execution, and verification of effectiveness. Even where the technical root cause is the manufacturer's, the MAH bears the regulatory responsibility in Japan.