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.
ARE YOU INTERESTED IN REGISTRATION IN NORWAY? REQUEST A FREE QUOTE>