HALMED current fee schedule, reviewed for 2026, in EUR.
14 fee lines100% exact amountscurrency EURFX rates 2026-09-17reviewed 2026-09-16
| Fee line | Official amount | USD equivalent | Frequency | Provenance |
|---|---|---|---|---|
| Entry in the register of manufacturers or authorised representatives (Upis / uskraćivanje upisa u očevidnik proizvođača ili zastupnika proizvođača) Group 8 item 1 of the HALMED price list. | EUR 700.00 | $805 | Per application | Verified |
| Change of an entry in the register of manufacturers or authorised representatives (Izmjena / uskraćivanje izmjene upisa) Group 8 item 2. | EUR 200.00 | $230 | Per application | Verified |
| Entry in the register of medical devices, 1 to 5 products Group 8 item 3. Items 4 and 5 charge EUR 900.00 for 6 to 30 products and EUR 1,000.00 for more than 30 products. | EUR 800.00 | $920 | Per application | Verified |
| Entry in the register of medical devices, 6 to 30 products Group 8 item 4. | EUR 900.00 | $1,035 | Per application | Verified |
| Entry in the register of medical devices, more than 30 products Group 8 item 5. | EUR 1,000.00 | $1,150 | Per application | Verified |
| Change of an entry in the register of medical devices (Izmjena upisa u očevidnik medicinskih proizvoda) Group 8 item 6. Item 7 charges EUR 200.00 where the registration decision itself is not changed. | EUR 300.00 | $345 | Per application | Verified |
| Risk classification of a medical device (Razvrstavanje medicinskog proizvoda s obzirom na klasu rizika) Group 8 item 8, on the manufacturer's request; item 9 charges the same amount for assigning a product to a device group on the manufacturer's enquiry. The published price is '1.000,00 € + dodatni troškovi ako je uključen vanjski stručnjak', so the expert component is dynamic and not a fixed published amount. | EUR 1,000.00 plus the cost of an external expert where one is engaged | $1,150 | Per request | Verified |
| Issue of the Single Registration Number (SRN broj) by enterprise size Group 8 items 22, 23 and 24 respectively. | EUR 400.00 (micro), EUR 600.00 (small), EUR 800.00 (medium or large) | $460 | Per issue | Verified |
| Free-sale certificate for one country (Potvrda o slobodnoj prodaji za jednu zemlju) Group 8 items 25 to 29 scale with the number of products: EUR 150.00 for 1 to 5, EUR 200.00 for 6 to 20, EUR 250.00 for 21 to 50, EUR 300.00 for 51 to 100 and EUR 380.00 for more than 100 products. The amount carried here is the lowest published line. | EUR 150.00 to EUR 380.00 | $173 | Per country and per application | Verified |
| Entry in the register of distributors (Upis / uskraćivanje upisa u registar distributera) Group 8 items 30 to 42 scale with enterprise size and the number of branch offices: EUR 400.00 for a micro enterprise, up to EUR 1,050.00 for a medium or large enterprise with more than 100 branches. The amount carried here is the lowest published line; the register is the one Article 9(2) of NN 100/2018 governs. | EUR 400.00 to EUR 1,050.00 | $460 | Per application | Verified |
| Maintenance of medical device status for manufacturers and authorised representatives established in Croatia Group 8 items 10 to 17 scale with the number of products, from EUR 200.00 for up to 10 products to EUR 800.00 for more than 1,000. Item 18 charges importers EUR 250.00. The price list footnotes this block: items 10 to 19 begin to be charged under Articles 29 and 30 of Regulation (EU) 2017/745, the EUDAMED registration duty. | EUR 200.00 to EUR 800.00 | $230 | Per maintenance period (period not stated in the price list) | Verified |
| Change of the person responsible for regulatory compliance in EUDAMED (Izmjena osobe odgovorne za usklađenost s propisima u Eudamedu) Group 8 item 19; part of the block the price list footnotes with the EUDAMED registration duty. | EUR 100.00 | $115 | Per change | Verified |
| Derogation from the conformity assessment procedures under Article 59 of Regulation (EU) 2017/745 and Article 54 of Regulation (EU) 2017/746 Group 8 item 69. | EUR 1,000.00 | $1,150 | Per application | Verified |
| Issue of the certificate of receipt of the notification of placing on the market (Izdavanje potvrde primitka obavijesti o stavljanju u promet) Group 8 item 71; item 72 charges EUR 70.00 to change the certificate. This is the charge for the certificate of receipt, not for the market notification itself. | EUR 100.00 | $115 | Per certificate | Verified |
Government fees only — service and testing costs are separate- The HALMED price list (Cjenik usluga HALMED-a) is in force since 9 March 2024, and the amendments in force from 1 July 2024 and from 1 April 2025 are implemented in the published text; group 8 'Medicinski proizvodi' carries 76 device items.
- Prices are expressed in euro excluding VAT: 'Cijene su izražene u eurima bez PDV-a.'
- The two risk bands are the reporter's grouping of published line items, not a published range. The low band is the spread between the EUR 200.00 change-of-registration line and the EUR 800.00 entry in the register of medical devices for 1 to 5 products. The high band is the spread between the EUR 900.00 entry for 6 to 30 products and the EUR 1,050.00 top of the distributor-register line for a medium or large enterprise with more than 100 branches.
- The tariff is not differentiated by device risk class: cost tracks the number of products registered, the size of the enterprise and the number of branches, so the bands are an approximation of scale rather than a class-based price.
- Applications for group 8 services must be created through HALMED's 'Web ponude' application, through which the applicant generates the offer on which payment is made.
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Exact amounts verified against the HALMED fee schedule · full review 2026-09-16 · row IDs are stable — cite as government-fees:croatia:manufacturer-register-entry