The Norwegian regulations require that any manufacturer, who has his registered place of  business in Norway, meaning  Norwegian manufacturers or Norwegian EU authorized representatives must register with the local register system of medical devices.

Although Norway is not a member of the European Union (EU), it has the same rights and obligations for medical devices as other EU Member States because it is a signatory to the European Economic Area agreement. Norway implemented the provisions of the Active Implantable Medical Device Directive (90/385/EEC), the Medical Device Directive (93/42/EEC) and the In Vitro Diagnostic Directive (98/79/EC)

Our territory specific (*) regulatory services in the European Union include:

Medical Device specific CE Mark regulation strategy reports, CE Mark Registration of all Medical Devices, IVDs and Active implant medical devices. Technical File and Design Dossier preparation, ISO13485 establishment and implementation, product validation consultation, EU Authorized Representative services and much more including Clinical Research planning and management and Arazy Group’s unique line of GlobaR - Global Regulatory Hub™ products.

GlobaR Dossier™
GlobaR - One World Process™
GlobaR Submission Center ™
Universal Authorized Representative™

Please fill in the following form and submit your inquiry or discuss it with one of our online specialists. Let's get your products registered in Norway!

(*) Norwegian Regulatory Affairs services are part of the diverse professional consulting services provided by Arazy Group and can be found thorough this web site and inquired on through our form or online chat services.