REGULATORY AUTHORITY: Medical devices in Liechtenstein are regulated by Amt für Gesundheit. Devices that have a CE Mark do not require additional registration.
CLASSIFICATION SYSTEM: Devices are classified according to the EU model of risk-based 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: Devices can remain on the market as long as their CE Mark is valid.
AUTHORIZED REPRESENTATIVE: An EU authorized representative is required.
ADDITIONAL INFORMATION: All product information must be translated into German.
Other Europe (non-EU) Countries: Belarus, Bosnia & Herzegovina, Iceland, Macedonia, Moldova, Norway, Serbia, Switzerland, Turkey, Ukraine