Switzerland
REGULATORY AUTHORITY:Medical device licensing in Switzerland is governed by Swissmedic, the Swiss agency for Therapeutic Devices. Devices that have a CE Mark do not require additional registration, but Swissmedic must be notified before placing certain types of devices, including Class I and IVD devices, on the market.

CLASSIFICATION SYSTEM:  Medical devices are classified along the EU model into Classes I, IIa, IIb, III, and IV.

TIMEFRAME: The EU registration process 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.

LICENSE VALIDITY:  Medical devices can remain on the Swiss market for as long as their CE Mark is valid.

AUTHORIZED REPRESENTATIVE:  An EU authorized representative is required.

Last updated on March 17 2015.



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