Danish Medicines Agency current fee schedule, reviewed for 2026, in DKK.
16 fee lines100% exact amountscurrency DKKFX rates 2026-08-26reviewed 2026-08-25
| Fee line | Official amount | USD equivalent | Frequency | Provenance |
|---|---|---|---|---|
| Distributor/importer registration No fee is charged for changes to the registration (BEK 1733/2025). | DKK 1,238 | $193 | Per registration | Verified |
| Manufacturer/authorised-representative registration DKMA practice: registration takes place via EUDAMED only and is free of charge from 28 May 2026; the BEK 839 amount is retained as the last published figure for completeness. | DKK 1,234 | $193 | Per registration | Verified |
| Annual supervision fee - manufacturers/AR of low-risk products 2026 amounts tiered by employee count. | DKK 6,298–56,682 | $983–$8,843 | Per year | Verified |
| Annual supervision fee - manufacturers/AR of medium/high-risk products 2026 amounts tiered by employee count. | DKK 32,403–291,639 | $5,055–$45,501 | Per year | Verified |
| Annual supervision fee - importers/distributors of Class I devices | DKK 5,416–48,745 | $845–$7,605 | Per year | Verified |
| Annual supervision fee - importers/distributors of Class IIa–III devices | DKK 27,448–247,027 | $4,282–$38,541 | Per year | Verified |
| Decision in a classification dispute (MDR Art. 51(2) request) | DKK 14,599 | $2,278 | Per decision | Verified |
| Opinion on a Class IIa/IIb conformity route (MDR Art. 52(9)) Paid by the notified body, not the manufacturer. | DKK 78,590 | $12,262 | Per opinion | Verified |
| Clinical-investigation application (non-implant, Class I–IIa) | DKK 46,835 | $7,307 | Per application | Verified |
| Clinical-investigation application (implantable, Class III, AIMD) | DKK 62,947 | $9,821 | Per application | Verified |
| Clinical investigation of a device without medical purpose (Annex XVI) | DKK 59,135–79,479 | $9,226–$12,400 | Per application | Verified |
| Clinical-investigation substantial modification Higher-track amendments: DKK 13,086. | DKK 10,364 | $1,617 | Per modification | Verified |
| Annual supervision of an ongoing clinical investigation | DKK 13,069 | $2,039 | Per year | Verified |
| IVD performance-study application Amendment: DKK 11,978; annual supervision: DKK 11,962. | DKK 54,127 | $8,445 | Per application | Verified |
| Ethics-committee application (clinical investigation) Amendment: DKK 4,561. IVD-study ethics application: DKK 29,041; amendment DKK 8,191. | DKK 18,275 | $2,851 | Per application | Verified |
| Export certificate | DKK 1,247 | $195 | Per certificate | Verified |
Government fees only — service and testing costs are separate- Annual supervision amounts are the 2026 gebyrsatser tiered by employee count; ranges span the published tiers.
- Device registrations under the EU framework are free via EUDAMED; only supervision and specific assessments are charged.
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Exact amounts verified against the Danish Medicines Agency fee schedule · full review 2026-08-25 · row IDs are stable — cite as government-fees:denmark:distributor-importer-registration