Registration for medical devices for medical devicesRegistration for Norwegian manufacturers and Norwegian authorised representatives of medical devices (not distributors).1685
Clinical investigation of medical devices investigation of medical devicesRegulatory guidance on clinical investigations of medical devices.1686
Classification classification of a medical device is deciding what type of conformity assessment procedure should be used before the device is placed on the marked.1688
Placing on the market of medical devices on the market of medical devicesProcedure and responsibility related to CE marking and placing on the market of medical devices.1692
Free Sales Certificate (English) Sales Certificate (English)Free Sales Certificate to Norwegian manufacturers of medical devices. 1693
Notified Body BodyNotified body has the task to conduct conformity assessments, i.e. to assess whether a medical device complies with the regulatory requirements.1694

Sist faglig oppdatert: 1. september 2016

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