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Medical devices

The Norwegian Medicines Agency is competent authority for medical devices, and has administrative and advisory responsibilities related to legislation and supervisory authority over manufacturers, distributors and notified bodies.

Norwegian language requirements	https://legemiddelverket.no/english/medical-devices/norwegian-language-requirements	Norwegian language requirements	According to current legislation labeling and information supplied by the manufacturer shall be in Norwegian.	2260
Regulatory information regarding medical devices	https://legemiddelverket.no/english/medical-devices/regulatory-information-regarding-medical-devices	Regulatory information regarding medical devices	Medical devices - Register. Clinical investigation. Classification. Placing on the market. Free sales certificate. Notified body. Administrative and advisory responsibilities related to legislation for medical devices.	1579
Reporting of adverse incidents involving medical devices	https://legemiddelverket.no/english/medical-devices/reporting-of-adverse-incidents-involving-medical-devices	Reporting of adverse incidents involving medical devices	Incidents with medical devices on the market, as well as injuries, accidents and failures where medical devices is or may have been involved, shall be reported to the Norwegian Medicines Agency.	1586
About medical devices	https://legemiddelverket.no/english/medical-devices/about-medical-devices	About medical devices	The Norwegian Medicines Agency's role regarding medical devices. Legislation related to medical devices. Legal interpretations.	1578
Glossary – Medical devices	https://legemiddelverket.no/english/medical-devices/glossary-–-medical-devices	Glossary – Medical devices		1587

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