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Re-examination and Re-evaluation Obligations

note

See also Re-examination System for context on the re-examination period and the application process from the pre-market approval perspective.

Post-approval surveillance period obligations​

Once a Shonin is granted and the re-examination period begins, the MAH has active ongoing obligations:

Surveillance data collection. The MAH must execute the GPSP-approved post-market surveillance programme. This typically means:

  • Enrolling patients at designated survey sites
  • Collecting outcome data at defined intervals
  • Tracking and reporting adverse events from survey patients
  • Monitoring literature for new safety and efficacy evidence

Interim safety reporting. If safety signals emerge during the re-examination period that are not captured by the standard adverse event reporting process, the MAH must bring them to MHLW's attention promptly.

Survey protocol amendments. Changes to the post-market surveillance protocol during the re-examination period must be reviewed and accepted by PMDA before implementation.

The re-examination application β€” what to submit​

The re-examination application must be submitted to PMDA before the end of the re-examination period. The application includes:

  1. Summary of use-results survey data β€” patient numbers, outcomes, adverse events recorded during the surveillance period
  2. Analysis of adverse event reports β€” all adverse event reports filed during the re-examination period, with trend analysis
  3. Literature review β€” systematic review of publications relevant to the device since approval
  4. MAH's benefit-risk assessment β€” integrating all data sources to conclude on the current benefit-risk balance

PMDA reviews the application and MHLW makes the re-examination decision.

Re-evaluation β€” MHLW-initiated review​

Re-evaluation (再評侑) is separate from MAH-initiated re-examination. MHLW can initiate a re-evaluation of any approved device category at any time when:

  • New safety evidence emerges that calls into question the approved benefit-risk profile
  • A class of devices is found to have systematic problems
  • International regulatory actions suggest risk signals not yet addressed in Japan

All MAHs holding approvals for the re-evaluated device category are required to provide data to MHLW on request. The outcome of a re-evaluation can range from no change to conditions being added to approvals, reclassification, or withdrawal of approvals.