Skip to main content

Near-Miss Reporting

JP-unique

Japan requires MAHs to collect and report near-miss events (ヒヤリ・ハット — Hiyari Hatto, literally "almost-miss events") involving medical devices. Near-miss reporting to MHLW is a Japan-specific requirement with no direct equivalent in EU MDR, FDA QSR/QMSR, or Australian TGA frameworks.

Definition of a near-miss in Japan​

A near-miss (Hiyari Hatto) in the Japanese regulatory context is a device-related incident that:

  • Did not result in patient harm, but
  • Could have caused harm if circumstances had been slightly different

Examples include:

  • A device alarm that failed to activate, where nursing staff happened to notice the patient issue by other means
  • Incorrect device labelling that was identified before administration rather than after
  • A device malfunction that was identified during a pre-use check before being applied to a patient

Collection obligations for MAHs​

MAHs are expected to actively collect near-miss information from:

  • Healthcare institutions using their devices (through post-market surveillance activities)
  • The MHLW/PMDA database of near-miss reports submitted by healthcare facilities (MHLW operates a separate near-miss reporting system for healthcare institutions)

The MAH's GPSP programme should include a process for collecting and analysing near-miss information.

Reporting to MHLW​

Near-miss events do not trigger the same 15/30-day individual adverse event reporting requirements as serious adverse events. Instead, near-miss data is typically included in:

  • Periodic post-market surveillance reports to MHLW
  • The re-examination application (for Shonin devices)

If a pattern of near-misses suggests a systemic safety issue, the MAH must assess whether the pattern triggers a more urgent safety communication or corrective action.

How near-miss data feeds post-market surveillance​

The systematic collection and analysis of near-miss data is a valuable input to the MAH's safety analysis. PMDA expects to see evidence of near-miss data collection and analysis in re-examination applications as part of the overall post-market safety evaluation.