CInMED current fee schedule, reviewed for 2026, in EUR.
11 fee lines100% exact amountscurrency EURFX rates 2026-09-17reviewed 2026-09-16
| Fee line | Official amount | USD equivalent | Frequency | Provenance |
|---|---|---|---|---|
| Registration of Class I medical devices — up to 25 products in the application Odluka čl. 2, item 2.1, Class I, up to 25 products. | EUR 100 | $115 | Per application, tiered by the number of products | Verified |
| Registration of Class I medical devices — over 100 products in the application Odluka čl. 2, item 2.1, Class I, over 100 products; the 26-100 tier is EUR 80. | EUR 60 | $69.02 | Per application, tiered by the number of products | Verified |
| Registration of Class IIa medical devices — up to 25 products in the application Odluka čl. 2, item 2.1, Class IIa, up to 25 products; the 26-100 tier is EUR 180 and the over-100 tier EUR 150. | EUR 200 | $230 | Per application, tiered by the number of products | Verified |
| Registration of Class IIb medical devices — up to 25 products in the application Odluka čl. 2, item 2.1, Class IIb, up to 25 products; the 26-100 tier is EUR 250 and the over-100 tier EUR 200. | EUR 300 | $345 | Per application, tiered by the number of products | Verified |
| Registration of Class III medical devices — up to 15 products in the application Odluka čl. 2, item 2.1, Class III, up to 15 products; over 15 products is EUR 350. | EUR 400 | $460 | Per application, tiered by the number of products | Verified |
| Registration of in vitro diagnostic medical devices — up to 25 products in the application Odluka čl. 2, item 2.1, IN VITRO, up to 25 products; the 26-100 tier is EUR 80 and the over-100 tier EUR 60. | EUR 100 | $115 | Per application, tiered by the number of products | Verified |
| Registration of active implantable devices and of apparatus belonging to classes I, IIa, IIb and III, and in vitro apparatus — up to 10 products Odluka čl. 2, item 2.1, the line covering AIMD and apparatus of classes I, IIa, IIb and III and in vitro apparatus, up to 10 products; 11-25 products is EUR 400 and over 25 is EUR 350. | EUR 450 | $518 | Per application, tiered by the number of products | Verified |
| Authorisation to import unregistered medical devices, under čl. 66 of the Law — up to 5 devices Odluka čl. 2, item 2.3; 6-10 devices is EUR 100, 11-15 is EUR 150, 16-20 is EUR 200 and over 20 is EUR 250. Čl. 67(2) of the Law gives CInMED 30 days to decide. | EUR 60 | $69.02 | Per authorisation, tiered by the number of devices | Verified |
| Annual vigilance-system maintenance per decision — Class III medical devices Odluka čl. 2, the vigilance line: Class I EUR 10, in vitro diagnostic devices EUR 10, Class IIa EUR 20, Class IIb EUR 30, Class III EUR 40, active implantable devices EUR 45. | EUR 40 | $46.01 | Per decision, annually | Verified |
| Decision on the classification of a medical device Odluka čl. 2, the decision line, classification of medical devices. The same line charges EUR 150 for deciding the classification of a drug/medical-device combination and EUR 150 for a medical device combined with an article of general use. | EUR 300 | $345 | Per request | Verified |
| Registration of a Class III medical device without a conformity document issued by an EU manufacturer or an EU-notified conformity-assessment body Odluka čl. 2, the line for devices without a conformity document from an EU manufacturer or an EU-notified body: Class I EUR 200, Class IIa EUR 500, Class IIb EUR 500, Class III EUR 600, active implantable devices and apparatus EUR 600, in vitro diagnostic devices EUR 200. | EUR 600 | $690 | Per application | Verified |
Government fees only — service and testing costs are separate- Čl. 2 of the Odluka prices registration by risk class and by the number of products in one application: Class I and in vitro diagnostic devices EUR 100 / 80 / 60 for up to 25, 26 to 100 and over 100 products; Class IIa EUR 200 / 180 / 150; Class IIb EUR 300 / 250 / 200; Class III EUR 400 up to 15 products and EUR 350 over 15; active implantable devices and apparatus EUR 450 / 400 / 350.
- Extension of a registration (produženje registracije) is not published as a fixed amount: čl. 2 sets it at 50% of the fee determined for the first entry of that medical device in the register, so it is deliberately not published here as an exact figure.
- All amounts in the Odluka are expressed exclusive of VAT (Obrazloženje: sve cijene u ovoj odluci izražene bez PDV-a), and čl. 4 gives the applicant 30 days from receipt of the invoice to pay.
- Čl. 5 refunds a withdrawal notified in writing within 7 days of filing, less 30% of the amount paid; a later withdrawal forfeits the whole fee.
- The Odluka was adopted by the Upravni odbor of the Institut za ljekove i medicinska sredstva on 27.12.2022 and published in Sl. list CG 035/23 of 27.03.2023; čl. 7 makes it enter into force on the eighth day after publication, following the Government's consent.
- The annual-fee table in čl. 3 is published only as a scanned image, so no figure from it is published; the Obrazloženje states the new annual maintenance fee for manufacturing and wholesale/retail authorisations ranges from 80 to 100 EUR.
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Exact amounts verified against the CInMED fee schedule · full review 2026-09-16 · row IDs are stable — cite as government-fees:montenegro:registration-class-i-up-to-25