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, 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.