CH-MANDATAIRE
Swiss authorised representative required
Foreign manufacturers must appoint an authorised representative established in Switzerland
- Category
- National requirements
- Market
- Switzerland
- Applicable classes
- Class I medical device, Class IIa medical device, Class IIb medical device, Class III medical device
In practice
The authorised representative must be registered with Swissmedic. It is responsible for conformity and is the contact for the authorities. A Swiss address is required on the labelling.
Official sources
https://www.swissmedic.ch/swissmedic/fr/home/dispositifs-medicaux/bewilligungen-zertifikate/schweizer-bevollmaechtigter.htmlSee where this text lands in your roadmap
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