Lyfjastofnun current fee schedule, reviewed for 2026, in ISK.
22 fee lines100% exact amountscurrency ISKFX rates 2026-09-17reviewed 2026-09-16
| Fee line | Official amount | USD equivalent | Frequency | Provenance |
|---|---|---|---|---|
| Free Sales Certificate (FSC) for a medical device — five copies Tariff item 1.1. Issued under 6. mgr. 6. gr. laga um lækningatæki nr. 132/2020. If issuing the certificate needs substantial preparation, the hourly rate in item 7.1 may be charged on top. | ISK 53,400 | $441 | Per certificate | Verified |
| Free Sales Certificate for a medical device or an IVD — price per copy beyond the first five Tariff item 1.2. | ISK 26,700 | $220 | Per additional copy | Verified |
| Other certificates — price per copy Tariff item 1.3. The hourly rate under item 7.1 may be added where issuing the certificate requires substantial preparation. | ISK 40,050 | $331 | Per copy | Verified |
| Registration of a distributor in Lyfjastofnun's distributor register Tariff item 2.1, charged under 3. mgr. 28. gr. laga um lækningatæki nr. 132/2020. 'Dreifingaraðili' covers every person or legal entity in the supply chain other than the manufacturer or importer who offers a device on the market until it is put into use. This is the only Icelandic entry that registers an operator rather than a device. | ISK 53,400 | $441 | Per registration | Verified |
| Maintenance of a distributor registration Tariff item 2.2. The separate maintenance charge shows the distributor registration is kept current rather than being a one-off filing. | ISK 26,700 | $220 | Per maintenance registration | Verified |
| Supervision of use — supervision of a medical device or an in vitro diagnostic medical device Tariff item 3.1, charged under 1. mgr. 16. gr. laga nr. 132/2020; supervision of use means checking that use matches the intended purpose and that users have minimum training. Where the supervision proves extensive the hourly rate in item 7.1 may be added, and the invoice issues once the supervision report exists. | ISK 160,200 | $1,322 | Per supervision case | Verified |
| Supervision of use — supervision of a management system Tariff item 3.2. | ISK 387,150 | $3,195 | Per supervision case | Verified |
| Assessment of an application for exemption from the CE-marking requirements — Class IIa devices and devices that are not invasive in Class IIb and III Tariff item 3.3, charged under 4. mgr. 3. gr. This is the lower-risk end of the only class-differentiated pair of amounts in the schedule. The Icelandic text reads 'lækningatæki í flokki IIa, og tæki sem ekki eru inngripstæki í flokki IIb og III'. | ISK 200,250 | $1,653 | Per application | Verified |
| Assessment of an application for exemption from the requirements — Class IIb and III devices, including implantable devices, invasive devices intended for long-term use and in vitro diagnostic medical devices Tariff item 3.4. This is the higher-risk end of the only class-differentiated pair of amounts in the schedule, and the reason the high-risk band is set at this figure. | ISK 293,700 | $2,424 | Per application | Verified |
| Other exemptions Tariff item 3.5. | ISK 200,250 | $1,653 | Per application | Verified |
| Supervision of maintenance — supervision of a medical device Tariff item 4.1, charged under 1. mgr. 17. gr. laga nr. 132/2020; supervision of maintenance covers periodic quality and safety inspection and servicing against the manufacturer's specification. | ISK 200,250 | $1,653 | Per supervision case | Verified |
| Supervision of maintenance — supervision of a management system Tariff item 4.2. | ISK 387,150 | $3,195 | Per supervision case | Verified |
| Market surveillance — distributors and importers Tariff item 5.1, charged under 1. mgr. 34. gr. laga nr. 132/2020. Lyfjastofnun takes up device-safety cases and operator-duty cases on its own initiative or on a report. | ISK 133,500 | $1,102 | Per supervision case | Verified |
| Quality management — distributors and importers Tariff item 5.2. | ISK 387,150 | $3,195 | Per supervision case | Verified |
| Market surveillance — manufacturers and authorised representatives Tariff item 5.3. The Icelandic text names the authorised representative as 'viðurkenndur fulltrúi', the EEA-established representative Act 132/2020 requires of a manufacturer outside the EEA. | ISK 133,500 | $1,102 | Per supervision case | Verified |
| Quality management — manufacturers and authorised representatives Tariff item 5.4. The highest item in the schedule. | ISK 774,300 | $6,391 | Per supervision case | Verified |
| Pre-check of the content of an application for a clinical or performance investigation — Class I devices, non-invasive Class IIa and IIb devices, and IVD Class A Tariff item 6.1, charged under 2. mgr. 6. gr. laga nr. 132/2020. | ISK 200,250 | $1,653 | Per application | Verified |
| Pre-check of the content of an application for a clinical or performance investigation — Class IIa, IIb and III devices and IVD Classes B, C and D Tariff item 6.2. The amount equals item 6.1: this part of the tariff turns on the check performed, not on the class. | ISK 200,250 | $1,653 | Per application | Verified |
| Assessment of an application for a clinical investigation of a medical device — all classes of device Tariff item 6.3. The item applies to every device class, so it is not a class-differentiated amount and is not used to build either risk band. Fees under 6. gr. are irrevocable even if the application is refused or withdrawn; where the fee does not cover the cost of assessment the applicant pays the hourly rate for the shortfall and may withdraw within 14 days of being told. | ISK 1,161,450 | $9,586 | Per application | Verified |
| Clinical investigation of medical devices approved by Lyfjastofnun Tariff item 6.4. | ISK 387,150 | $3,195 | Per approval | Verified |
| Amendments to a clinical investigation of medical devices Tariff item 6.5. | ISK 106,800 | $881 | Per amendment | Verified |
| Lyfjastofnun hourly rate — per specialist, per hour, for supervision and services under the Medical Devices Act Tariff item 7.1. Charged in addition to the fixed items where supervision proves extensive, where a certificate needs substantial preparation, for site inspections during a clinical investigation, and for follow-up and enforcement action under Chapter VII of Act 132/2020. | ISK 26,700 | $220 | Per specialist-hour | Verified |
Government fees only — service and testing costs are separate- Gjaldskrá nr. 1529/2025 is the fee schedule in force: it was made by the Ministry of Health on 17 December 2025 under the authority of 39. gr. laga um lækningatæki nr. 132/2020, took effect on 1 January 2026, and at that moment repealed gjaldskrá nr. 1555/2023.
- Iceland charges no device-registration fee and no device-approval fee, because it operates no national device registration and no national device approval. Every amount in this record is a certificate, operator-registration, supervision, clinical-investigation or hourly charge that an applicant or an operator can actually be billed for.
- The two risk bands are the reporter's grouping of published line items, not a published range. The schedule is a supervision and service tariff and all but one pair of its amounts are flat: the only amounts that turn on the device class are items 3.3 (ISK 200,250, Class IIa and non-invasive Class IIb/III exemption assessment) and 3.4 (ISK 293,700, Class IIb/III, including implantables, long-term invasive devices and IVDs). Both bands are therefore single published amounts rather than spreads, and the per-device cost of the tariff does not track the class axis.
- The most consequential charges are annual and risk-based rather than transactional: market surveillance of a manufacturer or authorised representative is ISK 133,500, and quality-management supervision of the same operator is ISK 774,300, so an Icelandic market presence is priced mainly through supervision rather than through a market-entry fee.
- Fees are exclusive of the travel and accommodation costs Lyfjastofnun charges separately under 8. gr. for on-site supervision, and are subject to the payment terms in 10. gr. — 30 days from invoice, with default interest and enforceability.
- Amounts are as published in the B-deild of Stjórnartíðinda; the Icelandic convention writes them with a full stop as the thousands separator, and they are rendered here with a comma.
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Exact amounts verified against the Lyfjastofnun fee schedule · full review 2026-09-16 · row IDs are stable — cite as government-fees:iceland:free-sales-certificate