REGULATORY AUTHORITY: Medical device licensing in Switzerland is governed by Swissmedic, the Swiss Agency for Therapeutic Devices.

CLASSIFICATION SYSTEM:

Medical devices are classified along with the EU model, using risk-based rules.

Medical Devices: Classes I, IIa, IIb and III.

IVD Devices: Same as the EU IVD

LICENSE VALIDITY:  Medical devices can remain on the Swiss market for as long as their CE Mark is valid, usually 5 years.

LICENSE TRANSFER: Similar to the EU, this process is not applicable.

AUTHORIZED REPRESENTATIVE/LICENSE HOLDER:  If the manufacturer of a medical device does not have its registered place of business in Switzerland, its products may only be placed on the market once an authorized representative domiciled in Switzerland has been appointed (Art. 51 para. 1 MedDO). This also applies to manufacturers with their registered place of business in the EU.

ADDITIONAL INFORMATION: Swissdamed is the new Swissmedic database for registering economic operators and medical devices, including in vitro diagnostic medical devices, on the Swiss market. The Actor registration module is released, and all economic operators should be registered. Device registration will become mandatory only when swissdamed has been sufficiently developed and relevant amendments have been made to the MedDO / IvDO.

Other Europe (non-EU) Countries: Belarus, Bosnia & Herzegovina, Iceland, Liechtenstein, Macedonia, Moldova, Norway, Serbia, Turkey, Ukraine