Medical Device Registration and Approval in Switzerland

General country-specific regulatory information is provided on this page for medical device registration and approval in Switzerland. Become a LICENSALE.COM user to receive detailed device-specific compliance information for each market, including Switzerland, free of charge, to expedite the preparation of your medical device or IVD registration application. 

Medical Device Regulations and Classification in 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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