INFARMED current fee schedule, reviewed for 2026, in EUR.
5 fee lines100% exact amountscurrency EURFX rates 2026-08-26reviewed 2026-08-25
| Fee line | Official amount | USD equivalent | Frequency | Provenance |
|---|---|---|---|---|
| Clinical-study application - non-CE device or CE outside intended purpose | EUR 1,000 | $1,167 | Per application | Verified |
| Clinical-study application - CE-marked device | EUR 600 | $700 | Per application | Verified |
| Study notification - non-CE device | EUR 600 | $700 | Per notification | Verified |
| Study notification - CE-marked device | EUR 400 | $467 | Per notification | Verified |
| Study protocol amendment | EUR 200 | $233 | Per amendment | Verified |
Government fees only — service and testing costs are separate- Amounts remain in force until 5 November 2026 plus indexation: Portaria 63/2015 as kept applicable by Lei 71/2025 art. 40(3), subject to annual CPI indexation.
- Portaria 327/2026/1 (published 6 August 2026, in force 6 November 2026) replaces these with EUR 1,250 (clinical-investigation application), EUR 1,250 (IVD performance-study application), EUR 750 (PMCF/PMPF notification), and EUR 250 (substantial modification); 90% is refunded if the submission is not validated, and payment must precede submission.
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Exact amounts verified against the INFARMED fee schedule · full review 2026-08-25 · row IDs are stable — cite as government-fees:portugal:clinical-study-application-non-ce