MEDICAL DEVICE REGISTRATION AND APPROVAL IN Norway

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 update: December 2022

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: BelarusBosnia & HerzegovinaIcelandLiechtensteinMacedoniaMoldovaSerbiaSwitzerlandTurkeyUkraine

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