General country-specific regulatory information is provided on this page for medical device registration and approval in Iceland.
We review our Regulatory Information frequently; please check back often for updates
REGULATORY AUTHORITY: Medical devices are regulated by the Icelandic Medicines Agency (IMA). Although Iceland is not a member of the European Union (EU), it is a signatory to the European Economic Area agreement. Devices can only be marketed and sold in Iceland if they already have a CE Mark.
CLASSIFICATION SYSTEM: Medical devices are classified according to risk into Classes I, IIa, IIb, III, and IV.
TIMEFRAME: The registration process in the EU takes about 4-6 weeks after submission for Class I devices. For the other classes, it depends on the contract with the notified body and the type of device.
LICENSE VALIDITY: Licenses issued in the EU are valid for five years.
AUTHORIZED REPRESENTATIVE: An authorized representative anywhere in the EU or EEA is required.
Other Europe (non-EU) Countries: Belarus, Bosnia & Herzegovina, Liechtenstein, Macedonia, Moldova, Norway, Serbia, Switzerland, Turkey, Ukraine
For detailed device-specific compliance information for each market, including Iceland, to expedite the preparation of your medical device or IVD registration application.
Did you know you can onboard your medical device or IVD compliance information to our system in less than 15 minutes?
And, in less than a minute, you can start your device-specific registration application and a complete county-specific registration process in this country or any of the other 140+ countries available for you through the Arazy Group Medtech registration platform.
