Агенција за лекови и медицински средства (MALMED) current fee schedule, reviewed for 2026, in EUR.
18 fee lines100% exact amountscurrency EURFX rates 2026-09-17reviewed 2026-09-16
| Fee line | Official amount | USD equivalent | Frequency | Provenance |
|---|---|---|---|---|
| Register entry — medical device of class I Чл. 11 point 1 of the Правилник за надоместоци as replaced by Сл. весник на РСМ бр. 86 од 28.4.2025: "класа I - 300 евра во денарска противвредност". The amount is fixed in euro and payable in the denar equivalent. | EUR 300 | $345 | Per device | Verified |
| Register entry — medical device of class II-а Чл. 11 point 1 as replaced: "класа II-а - 400 евра во денарска противвредност". | EUR 400 | $460 | Per device | Verified |
| Register entry — medical device of class II-б Чл. 11 point 1 as replaced: "класа II-б - 400 евра во денарска противвредност". Class II-а and class II-б are priced identically, so the tariff does not separate the two middle rungs. | EUR 400 | $460 | Per device | Verified |
| Register entry — medical device of class III Чл. 11 point 1 as replaced: "класа III - 500 евра во денарска противвредност". | EUR 500 | $575 | Per device | Verified |
| Register entry — in vitro diagnostic device on List А Чл. 11 point 2 as replaced: "во листа А - 300 евра во денарска противвредност". The IVD column is not ordered by risk: List А and List Б are each 300 euro while "all other" in vitro diagnostic devices are 400. | EUR 300 | $345 | Per device | Verified |
| Register entry — in vitro diagnostic device on List Б Чл. 11 point 2 as replaced: "во листа Б - 300 евра во денарска противвредност". | EUR 300 | $345 | Per device | Verified |
| Register entry — in vitro diagnostic device for self-diagnosis Чл. 11 point 2 as replaced: "за само-дијагностицирање – 200 евра во денарска противвредност". This is the lowest device-register line in the schedule. | EUR 200 | $230 | Per device | Verified |
| Register entry — all other in vitro diagnostic devices Чл. 11 point 2 as replaced: "за сите други средства за ин витро дијагностика - 400 евра во денарска противвредност". The residual IVD category is the most expensive IVD line, which is why the fee bands keyed to risk carry overlapping ranges rather than a monotone one. | EUR 400 | $460 | Per device | Verified |
| Minor variation notified to the register of medical devices Чл. 11 of the Правилник за надоместоци as replaced by Сл. весник на РСМ бр. 86 од 28.4.2025: a minor variation notified as part of the technological process or of the filed documentation, for which only a notice of record is issued, is 10 euro. A substantive variation is charged at 40% of the register-entry fee for the device's class, which is a formula and is therefore not published as a row here. | EUR 10 | $11.50 | Per variation | Verified |
| Parallel-import approval — medical device, up to 25 products of the same class, list or product group from one manufacturer Чл. 3 ст. 2 of the Правилник за надоместоци (Сл. весник на РМ бр. 188 од 02.11.2015): the parallel-import charge for a medical device is levied "за секој поединечен производ" and graduated by the number of protected or generic names of the device of the same class, list or product group from one manufacturer; the first band, up to 25 products, is 40 euro per product. | EUR 40 | $46.01 | Per product | Verified |
| Parallel-import approval — medical device, up to 100 products Чл. 3 ст. 2 of the base Правилник: "медицинско средство до 100 производи - 24 евра во денарска противвредност за секој производ одделно". | EUR 24 | $27.61 | Per product | Verified |
| Parallel-import approval — medical device, over 100 products Чл. 3 ст. 2 of the base Правилник: "медицинско средства над 100 производи - 8 евра во денарска противвредност" per product. | EUR 8 | $9.20 | Per product | Verified |
| Entry in the register of legal persons for wholesale trade in medical devices Чл. 8 ст. 5 of the Правилник за надоместоци, raised from 500 to 471 euro by чл. 1 of Сл. весник на РСМ бр. 110 од 22.5.2026, which replaced the words "500 евра во денарска противвредност" with "471 евра во денарска противвредност" in чл. 8 ст. 1 and ст. 5. Ст. 5 is the medical-device wholesale register; ст. 1 is the medicines wholesale authorisation. The same amendment added чл. 8 ст. 7, a 442 euro charge for a wholesale authorisation for narcotic drugs and psychotropic substances needed for the manufacture of medicines and medical devices. | EUR 471 | $542 | Per application | Verified |
| Entry in the register of specialised shops for retail trade in certain kinds of medical device Чл. 8 ст. 6 of the Правилник за надоместоци: "За запишување во регистарот на специјализирани продавници за промет на мало со одредени видови на медицински средства … 160 евра во денарска противвредност". This is the register referred to in чл. 130 of the Law. | EUR 160 | $184 | Per application | Verified |
| Authorisation to manufacture a medical device of a given type and model at a given place of manufacture Чл. 7 ст. 2 point 1 of the Правилник за надоместоци. Point 2 of the same provision charges 500 euro where only parts of the manufacturing process are carried out at the site. | EUR 1,000 | $1,150 | Per type, model and place of manufacture | Verified |
| Approval or notification for a clinical investigation of a medical device Чл. 6 ст. 1 of the Правилник за надоместоци: "Во постапката за издавање одобрение или известување за клиничко испитување на медицински средства, надоместоците … изнесуваат 240 евра во денарска противвредност". Ст. 3 of the same article charges 120 euro for an approval of changes to a clinical investigation. | EUR 240 | $276 | Per application | Verified |
| Opinion of the Ethics Committee for a clinical investigation of a medical device Чл. 6 ст. 2 of the Правилник за надоместоци: the same 240 euro applies to the opinion of the Ethics Committee for clinical and other investigations connected with medicines and medical devices. | EUR 240 | $276 | Per application | Verified |
| Assessment of documentation for a certificate classifying a product as a medicine or a medical device Чл. 14 ст. 1 of the Правилник за надоместоци: "надоместок за процена на документацијата за издавање потврда за класификација на производите како лекови или медицински средства - 45 евра во денарска противвредност". This is the charge for the Agency's assessment of the documentation for a borderline-classification certificate, which is the determination чл. 115 ст. 1 of the Law makes turn on the main purpose and mode of action defined by the manufacturer. | EUR 45 | $51.77 | Per application | Verified |
Government fees only — service and testing costs are separate- The tariff is set in euro under чл. 11 of the Правилник за надоместоци and is payable in the denar equivalent — the instrument's own words are "во денарска противвредност" on every line — so the published figures are the euro amounts.
- The device-register fees currently in force are those of чл. 11 as replaced by Сл. весник на РСМ бр. 86 од 28.4.2025 (in force 6 May 2025); the earlier чл. 11 of the base rulebook (Сл. весник на РМ бр. 188 од 02.11.2015) graded devices on a per-product scale of 40, 24 and 8 euro and no longer applies to a first register entry.
- The 2026 amendment (Сл. весник на РСМ бр. 110 од 22.5.2026, in force 23 May 2026) does not touch чл. 11; it amends чл. 8 (wholesale and specialised-retail registers) only.
- A substantive variation to a register entry is charged at 40% of the register-entry fee for the device's class rather than at a fixed amount, so the schedule publishes a formula on that line and no exact figure is available for it.
- Class II-а and class II-б are charged the same 400 euro, and the in vitro diagnostic column is not ordered by risk (List А and List Б 300 euro, self-diagnosis 200 euro, all others 400 euro), which is why the risk-keyed fee bands overlap.
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Exact amounts verified against the Агенција за лекови и медицински средства (MALMED) fee schedule · full review 2026-09-16 · row IDs are stable — cite as government-fees:north-macedonia:device-register-class-i