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Reporting Timelines

15-day reports​

A 15-calendar-day report is required when:

  • A patient died and there is reasonable possibility the device was involved
  • A patient suffered a serious injury and there is reasonable possibility the device was involved
  • An overseas regulatory authority issued a recall, safety alert, or withdrawal related to the device

The 15-day clock starts when the MAH first becomes aware of the event — not when the investigation is complete. If the investigation is ongoing, the MAH files an initial report within 15 days with available information, and a follow-up report when the investigation concludes.

30-day reports​

A 30-calendar-day report is required when:

  • A malfunction occurred that could cause death or serious injury if it were to recur
  • Overseas adverse event information is received that meets reportability criteria (in some cases 15 days applies — check the specific event type)

Periodic summary reports​

For certain device types and categories of malfunction, MHLW allows MAHs to submit periodic summary reports instead of individual event reports. Periodic summary reports aggregate events over a defined period (typically quarterly or annually) and are submitted as a batch. MHLW specifies which event types and device categories are eligible for periodic reporting.

Clock start — when does the timeline begin?​

The reporting clock starts when the MAH becomes aware of information that reasonably suggests a reportable event has occurred. This includes:

  • Receipt of a complaint from a healthcare institution or patient
  • Receipt of a report from the overseas manufacturer
  • Identification of a reportable event in the literature
  • Receipt of an overseas regulatory action affecting the device

The clock does not restart if additional information is received later — the initial awareness date is the start. If an event is initially unclear (e.g. a complaint that does not clearly indicate a serious injury), the MAH must use judgment about the start date, erring toward the earlier date when in doubt.

Determining 'reasonable possibility' of device causation:

MAHs must use clinical judgment to assess whether there is a reasonable possibility that the device contributed to the adverse event. This does not require proof of causation, but rather a reasonable basis to suspect the device's involvement based on:

  • The temporal relationship between device use and the event
  • Known or expected properties of the device
  • The patient's medical history and concurrent conditions
  • Reports in medical literature or from regulatory authorities

When causation is unclear or unlikely, the MAH must still document the decision and rationale in the complaint record. If new information later emerges that changes the causation assessment, a supplementary report may be required.