PMDA current fee schedule, reviewed for 2026, in JPY.
8 fee lines100% exact amountscurrency JPYFX rates 2026-09-16reviewed 2026-08-25
| Fee line | Official amount | USD equivalent | Frequency | Provenance |
|---|---|---|---|---|
| Shonin - Class II/III (Follow-on) | ¥1,879,900 | $12,122 | Per approval | Verified |
| Shonin - Class IV (Follow-on) | ¥3,080,600 | $19,865 | Per approval | Verified |
| Shonin - Class II/III (New, no clinical) | ¥11,816,400 | $76,197 | Per approval | Verified |
| Shonin - Class IV (New, no clinical) | ¥16,520,700 | $106,533 | Per approval | Verified |
| Shonin - Class II/III (New, clinical) | ¥13,016,900 | $83,939 | Per approval | Verified |
| Shonin - Class IV (New, clinical) | ¥17,721,200 | $114,274 | Per approval | Verified |
| Government application fee for device approval - categories (1)-(2) high-risk applications Fee Order Art. 12; paid to the government in addition to the PMDA review fee. | JPY 100,000 | $645 | Per application | Verified |
| Government application fee - category (5) designated devices with set review standards | JPY 33,300 | $215 | Per application | Verified |
Government fees only — service and testing costs are separate- PMDA route-specific review fees remain the current linked medical-device table.
- Fee Order Art. 33 PMDA review fees (paid in addition to the Art. 12 application fee) range from JPY 437,000 to 16,431,300: category (1) 16,431,300; (2) 9,381,400; (3) 11,727,000; (4) 5,618,800; (5) 545,000; (6) 437,000; (7) 2,991,200; (8) 2,244,900; (9) 1,790,500; name-only-different products 37,300; partial-change review of category (1) 8,224,300.
- Third-party registered certification-body fees are commercial and are not included.
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Exact amounts verified against the PMDA fee schedule · full review 2026-08-25 · row IDs are stable — cite as government-fees:japan:shonin-class-ii-iii-follow-on