Priority Review (Yusen Shinsa)
Yusen Shinsa (優先審査 — literally "priority examination") is Japan's expedited review pathway for medical devices that address serious or life-threatening conditions with no adequate existing treatment. The target review timeline is approximately half that of standard review.
Eligibility criteria
Priority review designation is available for devices that meet all of the following:
- Intended for a serious or life-threatening disease or condition
- No equivalent treatment or device is currently available in Japan, or the new device represents a significant improvement over existing options
- There is sufficient pre-clinical or early clinical evidence to support benefit
MHLW (through PMDA) determines eligibility based on a written application from the MAH submitted before or at the time of the full application.
How to apply
Priority review designation is requested by the MAH in a separate written application to MHLW/PMDA:
- Submit a written request describing the device, the condition it addresses, the unmet need, and the evidence base
- MHLW publishes a list of devices designated for priority review
- Designation can be sought at any point before or concurrent with the main application submission
Target review timelines under priority review
| Review component | Priority review target |
|---|---|
| PMDA review time | 6 months |
| Total target (including MAH response time) | 9 months |
These are targets, not guarantees. Complex devices with significant Q&A rounds will take longer even under priority review designation.
Relationship with SAKIGAKE designation
Priority review (Yusen Shinsa) and SAKIGAKE designation are separate but complementary. SAKIGAKE (先駆け審査指定制度) provides additional benefits — including early and intensive PMDA consultation — and also triggers priority review. Devices with SAKIGAKE designation automatically receive priority review treatment. See Special Access and Designations for more on SAKIGAKE.