Lyfjastofnun GjaldskráGjaldskrá nr. 1529/2025
Gjaldskrá nr. 1529/2025 is the official IMA identifier for “Gjaldskrá vegna eftirlits Lyfjastofnunar með lækningatækjum (Fee schedule for the Icelandic Medicines Agency's supervision of medical devices)”. Gjaldskrá nr. 1529/2025 is the official identifier IMA uses for this instrument.
- Instrument
- Gjaldskrá
- Full name
- Gjaldskrá nr. 1529/2025
- Category
- Registration
- Authority source
- Icelandic
- Readable HTML
- 11 articles · 1 language version
- Published
- 30 December 2025
- Effective
- 1 January 2026
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Gjaldskrá vegna eftirlits Lyfjastofnunar með lækningatækjum (Fee schedule for the Icelandic Medicines Agency's supervision of medical devices)
Gjaldskrá nr. 1529, signed 17 December 2025 and published in the B-deild of Stjórnartíðindi on 30 December 2025, setting the fees for Lyfjastofnun's supervision of medical devices. It is made by Heilbrigðisráðuneytið (the Ministry of Health) under the authority of Article 39 of lög nr. 132/2020 and on proposals from Lyfjastofnun, and it took effect on 1 January 2026; at the same time it repeals the previous schedule, gjaldskrá nr. 1555/2023. Eleven numbered fee groups are ingested, covering certificates — including the free sale certificate and the certificate for an in-vitro diagnostic device, priced per copy above the first five — as well as registration, inspection, clinical investigation and other supervisory fees. The issuer is the Ministry and the proposing body is Lyfjastofnun; the registry regulator label is used for this row and the distinction is stated here.
Gjaldskrá nr. 1529/2025 is the official identifier IMA uses for this instrument. Always confirm the current consolidated text and transition provisions with the official source before filing.