Registration for medical deviceshttps://helsedirektoratet.no/english/medical-devices/regulatory-information/registration-for-medical-devicesRegistration for medical devicesRegistration for Norwegian manufacturers and Norwegian authorised representatives of medical devices (not distributors).1685Artikkel
Clinical investigation of medical deviceshttps://helsedirektoratet.no/english/medical-devices/regulatory-information/clinical-investigation-of-medical-devicesClinical investigation of medical devicesRegulatory guidance on clinical investigations of medical devices.1686Artikkel
Classificationhttps://helsedirektoratet.no/english/medical-devices/regulatory-information/classificationClassificationRisk classification of a medical device is deciding what type of conformity assessment procedure should be used before the device is placed on the marked.1688Artikkel
Placing on the market of medical deviceshttps://helsedirektoratet.no/english/medical-devices/regulatory-information/placing-on-the-market-of-medical-devicesPlacing on the market of medical devicesProcedure and responsibility related to CE marking and placing on the market of medical devices.1692Artikkel
Free Sales Certificate (English)https://helsedirektoratet.no/english/medical-devices/regulatory-information/free-sales-certificate-englishFree Sales Certificate (English)Free Sales Certificate to Norwegian manufacturers of medical devices. 1693Artikkel
Notified Bodyhttps://helsedirektoratet.no/english/medical-devices/regulatory-information/notified-bodyNotified BodyNotified body has the task to conduct conformity assessments, i.e. to assess whether a medical device complies with the regulatory requirements.1694Artikkel

Sist faglig oppdatert: 1. september 2016

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