ALMBiH current fee schedule, reviewed for 2026, in BAM.
17 fee lines100% exact amountscurrency BAMFX rates 2026-09-17reviewed 2026-09-16
| Fee line | Official amount | USD equivalent | Frequency | Provenance |
|---|---|---|---|---|
| Entry in the Register of medical devices, Class I — up to 25 products by protected or generic name in the application Pravilnik čl. 16(1)(a)(1). The tiers are 200 KM up to 25 products, 150 KM up to 100 and 100 KM over 100. | BAM 200 | $118 | Per individual product in the application, tiered by the number of names | Verified |
| Entry in the Register of medical devices, Class I — over 100 products by protected or generic name in the application Pravilnik čl. 16(1)(a)(3). This is the floor of the Class I band. | BAM 100 | $58.82 | Per individual product in the application, tiered by the number of names | Verified |
| Entry in the Register of medical devices, Classes IIa and IIb — up to 25 products by protected or generic name in the application Pravilnik čl. 16(1)(b)(1). Classes IIa and IIb share one tariff line: 400 KM up to 25 products, 350 KM up to 100 and 300 KM over 100. | BAM 400 | $235 | Per individual product in the application, tiered by the number of names | Verified |
| Entry in the Register of medical devices, Classes IIa and IIb — over 100 products by protected or generic name in the application Pravilnik čl. 16(1)(b)(3). This is the floor of the IIa/IIb band. | BAM 300 | $176 | Per individual product in the application, tiered by the number of names | Verified |
| Entry in the Register of medical devices, Class III — up to 15 products by protected or generic name in the application Pravilnik čl. 16(1)(c)(1). Over 15 products the line drops to 500 KM. | BAM 700 | $412 | Per individual product in the application, tiered by the number of names | Verified |
| Entry in the Register of medical devices, Class III — over 15 products by protected or generic name in the application Pravilnik čl. 16(1)(c)(2). | BAM 500 | $294 | Per individual product in the application, tiered by the number of names | Verified |
| Entry in the Register of medical devices, in vitro diagnostic devices — up to 25 products by protected or generic name in the application Pravilnik čl. 16(1)(d)(1). The in vitro line is charged at the Class I rate: 200 KM up to 25, 150 KM up to 100 and 100 KM over 100, notwithstanding that in vitro lists A and B are the highest-risk lists on the classification axis. | BAM 200 | $118 | Per individual product in the application, tiered by the number of names | Verified |
| Entry in the Register of medical devices, active implantable devices — up to 10 products by protected or generic name in the application Pravilnik čl. 16(1)(e)(1). Active implantable devices have their own line: 800 KM up to 10 products, 600 KM up to 25 and 500 KM over 25. | BAM 800 | $471 | Per individual product in the application, tiered by the number of names | Verified |
| Entry in the Register of medical devices, active implantable devices — over 25 products by protected or generic name in the application Pravilnik čl. 16(1)(e)(3). This is the ceiling of the active-implantable line. | BAM 500 | $294 | Per individual product in the application, tiered by the number of names | Verified |
| Amendment of an entry in the Register of medical devices Pravilnik čl. 16(1)(g). Čl. 71(3) of the Pravilnik o medicinskim sredstvima lists the amendments that may be requested, including a change of the device's class. | BAM 200 | $118 | Per request | Verified |
| Supplement of an entry in the Register of medical devices Pravilnik čl. 16(1)(h). | BAM 200 | $118 | Per request | Verified |
| Expert opinion relating to a medical device Pravilnik čl. 16(1)(i). | BAM 100 | $58.82 | Per opinion | Verified |
| Issue of a certificate of conformity for a medical device Pravilnik čl. 16(1)(j). This is the fee for the conformity certificate that čl. 102 of the Law makes the basis for affixing the conformity mark. | BAM 1,000 | $588 | Per certificate | Verified |
| Decision on a request to classify a medical device Pravilnik čl. 16(1)(k). | BAM 200 | $118 | Per request | Verified |
| Authorisation for a clinical investigation of a medical device Pravilnik čl. 21(a). The notification of a clinical investigation of an already-registered device is 1,000 KM under čl. 21(b), amendments and supplements to the authorisation 400 KM under čl. 21(c), minor administrative changes 200 KM under čl. 21(d) and the adverse-event report that forms part of a renewal dossier 300 KM under čl. 21(e). | BAM 3,000 | $1,765 | Per authorisation | Verified |
| Certificate of the existence and duration of an entity permit linked to an entry in the Register of medical devices Pravilnik čl. 20. The Agency charges for certifying the existence and duration of an entity permit held by a holder of a Register entry, which is direct evidence that the entity permits exist alongside the state Register entry rather than replacing it. | BAM 300 | $176 | Per certificate | Verified |
| Administrative fee stamped on each request form submitted to the Agency Required as 'Dokaz o uplati 20 KM administrativne takse' on every request form in the Agency's documentation list of 30.10.2025, paid to the BiH Treasury. It is a separate charge from the Pravilnik 70/09 fees above. | BAM 20 | $11.76 | Per request form | Verified |
Government fees only — service and testing costs are separate- The tariff is graded by class and by the number of protected or generic names in one application: Class I and in vitro diagnostic devices 200 / 150 / 100 KM for up to 25, up to 100 and over 100 products; Classes IIa and IIb 400 / 350 / 300 KM; Class III 700 KM up to 15 products and 500 KM over 15; active implantable devices 800 / 600 / 500 KM.
- Renewal of an entry (obnova upisa) is not published as a fixed amount: čl. 16(1)(f) sets it at 50% of the amount of the first entry in the Register, so it is deliberately not published here as an exact figure.
- All amounts are expressed in KM without value added tax (Uvodni dio: 'Visina troškova je iskazana u KM bez uračunatog PDV').
- The Pravilnik was adopted by the Council of Ministers at its 94th session held on 16 July 2009, on the proposal of the Agency's director, under čl. 112(3) and related provisions of the Zakon o lijekovima i medicinskim sredstvima (Službeni glasnik BiH 58/08), and čl. 24 makes it enter into force on the day of its adoption; it was published in Službeni glasnik BiH br. 70 of 7 September 2009.
- The register-entry fee is charged 'za svaki pojedinačni proizvod iz zahtjeva prema broju zaštićenih ili generičkih naziva medicinskih sredstava', that is per individual product counted by the number of names in the application, not per application.
- Advertising authorisations carry their own tariff under čl. 17: 1,000 KM to issue, 800 KM to renew and 500 KM to amend or supplement. Registration of a legal person in the register of manufacturers is charged under čl. 18, including 1,000 KM for the quality-system procedure and 500 KM for a good-manufacturing-practice certificate; entry in the register of wholesalers is charged under čl. 19.
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Exact amounts verified against the ALMBiH fee schedule · full review 2026-09-16 · row IDs are stable — cite as government-fees:bosnia-and-herzegovina:entry-class-i-up-to-25-products