REGULATORY AUTHORITY: Medical devices are regulated by the Norwegian Medicines Agency.
CLASSIFICATION SYSTEM: Medical devices are classified according to risk, based on EU classes.
Medical Devices: Classes I, IIa, IIb and III.
IVD Devices: Same as in the EU – List A & B, Self testing, all others
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.
Class I: The registration process takes approximately the same time as in the EU.
Class II: The registration process takes approximately the same time as in the EU.
Class III: The registration process takes approximately the same time as in the EU.
IVD Devices: The registration process takes approximately the same time as in the EU.
Audits: An ISO 13485 audit, based on the CE requirements, is required.
Technical Local Tests: No local testing is required.
Clinical Evaluation/studies: No clinical evaluation studies are required.
Application review fees: Not applicable in Norway.
Manufacturer registration: Not applicable in Norway.
LICENSE VALIDITY: Licenses issued in the EU are valid for five years, based on the CE Certificate.
LICENSE TRANSFER: This process is not applicable, similar to the EU.
AUTHORIZED REPRESENTATIVE/LICENSE HOLDER: An authorized representative anywhere in the European Union is required.
ADDITIONAL INFORMATION: Norwegian manufacturers and authorized representatives shall register all medical devices in the Medical Device Database before it is placed on the market.