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Japan Medical Device Registration Fees
PMDA government fees for 2025
JPY 0
Low Risk Min
JPY 17,721,200
High Risk Max
PMDA
Authority
2025-12-16
Last Updated
Japan (PMDA) Fee Overview
Japan (PMDA) fees vary dramatically based on device class and clinical requirements. Basic Class II devices start around ¥267,000 (~$1,800), but Class IV devices requiring clinical trials can exceed ¥17.7 million (~$118,000). Japan uses a Shonin (approval) system for higher-risk devices and Todokede (notification) for lower-risk.
Complete Fee Breakdown
| Fee Item | Amount | Frequency |
|---|---|---|
Todokede - Class I (Notification) | Free | Per product |
Ninsho - Class II (Certification) Third-party certification | ¥500,000 | Per product |
Shonin - Class II/III (Follow-on) | ¥1,879,900 | Per approval |
Shonin - Class IV (Follow-on) | ¥3,080,600 | Per approval |
Shonin - Class II/III (New, no clinical) | ¥11,816,400 | Per approval |
Shonin - Class IV (New, no clinical) | ¥16,520,700 | Per approval |
Shonin - Class II/III (New, clinical) | ¥13,016,900 | Per approval |
Shonin - Class IV (New, clinical) | ¥17,721,200 | Per approval |
Key Facts About PMDA Fees
- 1Class II notification: ¥267,000 (~$1,800)
- 2Class III/IV approval: ¥2.8-17.7 million
- 3Foreign manufacturer registration required
- 4JIS/JGMP compliance needed
- 5Designated Management Medical Devices (DMMD) for some classes
Important Notes
- •Class I (Todokede): Free notification
- •Class II (Ninsho): Third-party certification
- •Class III/IV (Shonin): PMDA approval required
- •One of the most expensive markets globally
Tips for Japan Registration
- 1Consider using predicate devices for faster approval
- 2Register your foreign manufacturing site first
- 3Clinical equivalence can reduce Class IV timeline
Frequently Asked Questions
Related Resources
Government fees are subject to change. Last data update: 2025-12-16. Always verify current fees with PMDA.