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Periodic Safety Update Reporting

Periodic reporting obligations for MAHs​

MAHs are required to submit periodic reports to MHLW summarising the safety profile of their approved devices. The specific frequency and format of periodic reporting depends on the device type, class, and conditions attached to the approval.

Typical periodic reporting requirements:

  • Annual safety summary — a brief annual report submitted to MHLW summarising adverse events, complaints, and any safety actions taken during the year
  • Re-examination period reports — more detailed periodic reports at intervals specified by MHLW (often annually or at defined intervals during the re-examination period)
  • Post-approval study reports — if the approval has conditions requiring post-market studies, interim reports are submitted at specified intervals

Content of periodic safety reports​

A Japan periodic safety report for a medical device typically includes:

  1. Summary of adverse event reports filed with MHLW during the period (with analysis of trends)
  2. Summary of near-miss reports collected from users
  3. Summary of complaints received and investigated
  4. Summary of FSCAs / recalls executed during the period
  5. Literature review summary — significant new publications affecting the safety profile
  6. MAH's overall assessment of the device's safety profile and benefit-risk balance
  7. Post-market study updates — status of any ongoing GPSP studies

Timelines and submission process​

Reports are submitted to PMDA (for Shonin devices) via the PMDA electronic gateway. Submission deadlines are set at the time of approval and must be met — late submission without MHLW notification is a compliance issue.