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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.