Re-examination System
Japan's re-examination system requires MAHs to collect post-market data over a defined surveillance period following Shonin approval, and then submit a re-examination application confirming the device's continued safety and efficacy. This is a Japan-unique requirement with no direct equivalent in EU MDR or FDA.
What re-examination is
Re-examination (再審査 — saishinsū) is a mandatory post-approval process for Shonin-approved devices. After the approval is granted, a re-examination period begins. During this period, the MAH must:
- Operate a GPSP-compliant post-market surveillance programme
- Collect use-results data from healthcare settings in Japan
- Track all adverse events and safety signals
At the end of the period, the MAH submits a re-examination application to PMDA/MHLW containing a comprehensive analysis of the accumulated data.
Re-examination periods by device type
The re-examination period varies by device type and is set at the time of approval:
| Device type | Typical re-examination period |
|---|---|
| Standard new device (Class III/IV) | 3 years |
| Novel or innovative devices | Up to 7 years |
| Devices with conditional approval | As specified in approval conditions |
| Regenerative medicine products | Typically 7 years |
The period begins on the date the Shonin is issued.
Data collection obligations
During the re-examination period, the MAH must collect data through:
- Use-results survey (使用成績調査) — systematic collection of clinical outcomes data from Japanese healthcare institutions using the device
- Complaint and adverse event records — all complaints and adverse events reported to the MAH must be systematically tracked
- Safety communications and recalls — any safety actions must be documented
Submitting the re-examination application
The re-examination application is submitted to PMDA before the end of the re-examination period. It includes:
- Summary of use-results survey data
- Analysis of adverse events and complaints
- Literature review of newly published safety and efficacy data
- MAH's overall benefit-risk assessment
PMDA reviews the application and MHLW makes a decision. Outcomes:
- Re-examination passed — approval confirmed; ongoing obligations continue
- Re-examination with conditions — MHLW attaches new conditions
- Revocation — rare, but possible if data reveals unacceptable risk
Re-evaluation (re-hyōka)
Re-evaluation (再評価 — saihyōka) is different from re-examination. Re-evaluation is MHLW-initiated and can apply to any device class at any time, not just Shonin devices within their re-examination period. MHLW initiates re-evaluation when new safety information emerges that calls into question the benefit-risk profile of an entire device category.