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.
Failure to submit the re-examination application by the deadline may result in automatic suspension of the approval until the application is received. The MAH should submit well before the deadline to allow PMDA adequate review time. If extenuating circumstances prevent timely submission, the MAH should contact PMDA immediately to discuss options.