Importers and Distributors

Importers ​ An importer is any person established in Switzerland who places a non-Swiss manufacturer's device on the Swiss market. Under MedDO Art. 12–13, importers must: Verify that conformity assessment has been completed and the device is lawfully CE-marked (if applicable under the MRA) or registered in DAPI Verify that a CH REP has been appointed (where required by MedDO) Verify Swiss labelling compliance, ensuring all labelling text is in German, French, or Italian as required Maintain records for 10 years (general devices) or 15 years (implantable devices) Report non-conformities, serious adverse events, and FSCAs to the manufacturer or CH REP without undue delay

When an importer becomes a manufacturer: If an importer places a device on the market under their own name or makes modifications affecting conformity, they assume all manufacturer obligations under MedDO Art. 4.

Distributors

Distributors must verify labelling compliance, not supply non-compliant devices, maintain records, and cooperate with Swissmedic surveillance activities.