Medical Device Regulatory Requirements in Norway
| Regulatory Authority |
Norwegian Medical Products Agency (NOMA) |
| Regulatory Authority Website Link |
Click Here
|
| Device Classification |
I, IIa, IIb and III |
| Medical Device Regulations |
Guidance and regulations - Norwegian Medical Products Agency
| Click Here
|
| IVD Classification |
A,B,C,D |
| In Vitro Diagnostics Regulations |
(EU) 2017/746
| Click Here
|
| Registration Process |
Norwegian register for devices and EUDAMED
| Click Here
|
| Registration Timeline |
For Class I, it is 1 to 2 months and for other classes, it depends on the notified body and type of product |
| Requirement of Authorized Representative |
Yes |
| Language Requirement |
Labels must be in Norwegian
Language |
| Database |
Norwegian Register for Medical Devices_
| Click Here
|
| Adverse Event Reporting Form |
Download |
| Additional Information |
The registration requirement does not apply to foreign manufacturers and authorized representatives who place equipment on the Norwegian market through a Norwegian importer or distributor. Distributors and importers also have no registration obligation. |
Disclaimer: This website sources information from regulatory authorities and aims for accuracy, but regulations may change without notice. Users are advised to verify details with relevant authorities before making compliance decisions. We are not responsible for errors, omissions, or outdated content.
The above information is last updated on 09/Apr/2025