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What Must Be Reported

Adverse event reporting obligations for medical device MAHs are established in PMD Act Article 68-2 and the associated Ministerial Ordinance on Safety Measures for Medical Devices. These set out what must be reported, to whom, and within what timelines.

Reportable adverse events — overview​

Japan's adverse event reporting system for medical devices requires MAHs to report to MHLW when:

  1. A patient died and there is reasonable possibility the device contributed
  2. A patient suffered a serious injury and there is reasonable possibility the device contributed. "Serious injury" includes:
    • Life-threatening situations
    • Permanent impairment of a body function or permanent damage to a body structure
    • Condition requiring medical or surgical intervention to prevent permanent impairment
    • Hospitalisation or prolonged hospitalisation
    • Any condition considered serious by a physician
  3. A malfunction occurred that, if it were to recur, would likely cause a death or serious injury
  4. An infection was transmitted by the device

Serious injury and death reports​

For death or serious injury reports, the MAH must:

  • Report to MHLW within 15 calendar days (for events where there is reasonable possibility of device causation)
  • Include: device description, event description, patient details, investigation status, and initial assessment of causation
  • Submit a follow-up report once the investigation is complete if new information becomes available

Malfunction reports​

For device malfunctions (without associated death or serious injury but with potential to cause harm if recurring):

  • Report to MHLW within 30 calendar days
  • Include: device description, nature of malfunction, number of units affected, and corrective actions taken or planned

Overseas adverse events​

MAHs must also report adverse events that occur overseas involving the same device when:

  • The event would be reportable if it occurred in Japan
  • The event may have implications for Japanese patients

MHLW has specific guidance on the reporting timelines for overseas events (generally 15 or 30 days from the MAH becoming aware of the overseas event).

Infection transmission reporting:

When a device is implicated in transmitting an infection to a patient, the event is reportable regardless of whether the infection resulted in serious injury or death. This includes:

  • Contamination of the device during manufacture or processing that was not detected before use
  • Device design or material defects that allow bacterial colonization or biofilm formation
  • Failure of a sterilisation process affecting the device

Infection transmission events should be reported within 30 days unless the patient suffered serious injury or death (15-day reporting applies). Coordinate with infection control and hospital epidemiology departments to identify and investigate potential device-related infection clusters.