CASubmissionFee object

Fees

Fee depends on categories regarding implantable vs non implantable, intervention vs non- intervention and long term vs short term use.
Range: 400.000.-600.000 ISK (approx. 2800 EUR – 4200 EUR)
Major changes in clinical testing of medical devices: 150.000 ISK (approx. 1053 EUR)
Minor changes in clinical testing of medical devices: 25.000 ISK (approx. 175 EUR)

Waiver for academic (non-commercial) studies possible

Yes

Official guidance on required fees available

Yes

Official guidance on required fees

Tariff for evaluation of applications on clinical tests on medical devices nr. 1295/2013, available in Icelandic only.
(Gjaldskrá vegna mats á umsóknum um klínískar prófanir á lækningatækjum nr. 1295/2013)

This project (ECRIN Integrating Activity/ECRIN-IA) has received funding from the European Union’s Seventh Framework Programme for research, technological development and demonstration under grant agreement no 284395
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