Norway Medical Device Registration - Helsedirektoratet ...
2019-3-29u2002·u2002Medical Devices: Classes I, IIa, IIb and III. IVD Devices: Same as in the EU – List A & B, Self testing, all others. TIMEFRAME: The registration process in the EU takes about 4-6 weeks after submission for Class I devices. For the other classes, it depends on the contract with the notified body and the type of device.
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