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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.
Last updated on November 24th, 2021.
Medical Device Regulations and Classification in Norway
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.
SPECIAL REQUIREMENTS:
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.
LOCAL FEES:
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.
Other Europe (non-EU) Countries: Belarus, Bosnia & Herzegovina, Iceland, Liechtenstein, Macedonia, Moldova, Serbia, Switzerland, Turkey, Ukraine
For detailed device-specific compliance information for each market, including Norway, to expedite the preparation of your medical device or IVD registration application.
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