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, 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.
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