Medical Device Registration and Approval in Norway

General country-specific regulatory information is provided on this page for medical device registration and approval in Norway. Become a LICENSALE.COM user to receive detailed device-specific compliance information for each market, including Norway, free of charge, to expedite the preparation of your medical device or IVD registration application.

Medical Device regulations and Classification in Norway

REGULATORY AUTHORITY: Medical devices are regulated by the Norwegian Directorate of Health. Although Norway 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 Norway if they already have a CE Mark.

CLASSIFICATION: 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 European Union is required.

Last updated on March 24 2015.