Cjenik usluga HALMED-a

The scale of fees the Agency charges for the services it performs, published as the currently valid Cjenik usluga HALMED-a, in force from 9 March 2024 with the amendments in force from 1 July 2024 and from 1 April 2025 incorporated. It is issued under Article 28 of the Zakon o provedbi Uredbe (EU) 2017/745 i 2017/746, which leaves the fees for the activities laid down by the two Regulations to a decision of the minister, and the published page records the three consents behind it: the Minister of Health’s letters of 29 February 2024, 17 May 2024 and 13 March 2025 (KLASA 530-09/24-04/04 and 530-09/25-04/07) and the Minister of Agriculture’s determination for the veterinary-medicinal products. It runs to thirteen numbered groups, in the publisher’s own numbering, of which group 8 Medicinski proizvodi is the device schedule: registration and refusal of registration in the register of manufacturers and authorised representatives (700 €, amendment 200 €); registration of devices in the register of medical devices by band (800 € for 1 to 5 devices, 900 € for 6 to 30, 1,000 € for more than 30); amendment of a device registration (300 €, or 200 € where the registration decision itself is unchanged); risk-class classification of a device and classification of a product into a device group on the manufacturer’s request (1,000 € plus the cost of an external expert where one is engaged); the annual maintenance of device status for manufacturers and authorised representatives established in Croatia (200 € up to 10 devices, 250 € for 11 to 40, 300 € for 41 to 70, 350 € for 71 to 150, and by further band above that); and items 10 to 19, which the group’s own footnote states begin to be charged under Articles 29 and 30 of Regulation (EU) 2017/745, the obligation to register devices and economic operators in EUDAMED. Group 13 (scientific opinion on a substance with an ancillary action) and group 10 (clinical investigations) are also device-relevant. The page is the instrument itself, not a page about it: the introductory paragraphs fix which version is in force and the ministerial consents behind it, and the numbered groups are its own structural unit, so the whole cjenik is ingested and segmented that way rather than only the device group.

Cjenik usluga HALMED-a is the official identifier HALMED uses for this instrument. Always confirm the current consolidated text and transition provisions with the official source before filing.