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Swissmedic
Swiss Agency for Therapeutic Products
Switzerland
Swissmedic regulates medical devices in Switzerland under the revised Medical Devices Ordinance (MedDO), which is largely aligned with EU MDR. Switzerland recognizes EU CE certificates for most device classes, simplifying market access for manufacturers already compliant with EU MDR.
DEVICE CLASSES
Class I, IIa, IIb, III
APPROVAL PATHWAY
EU CE recognition / Swiss conformity assessment
KEY REGULATORY FUNCTIONS
- ▸MedDO compliance oversight
- ▸Recognition of EU CE certificates
- ▸Swiss market surveillance
- ▸MDSAP participation
OFFICIAL WEBSITE
https://www.swissmedic.ch →MedFlux monitors Swissmedic regulatory changes, safety alerts, and market signals in real time — so your team never misses a critical update.
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