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 conformity assessment has been completed and the device is lawfully CE-marked or Swiss-registered
- Verify a CH REP has been appointed (where required)
- Verify Swiss labelling compliance (DE/FR/IT language requirements)
- Maintain records for 10 years (general) or 15 years (implantable devices)
- Report non-conformities, serious incidents, and FSCAs to the manufacturer/CH REP
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.
Official Sources
Disclaimer
Content is AI-assisted and intended as a navigation aid only. Always verify against official Swissmedic and Fedlex sources. Not legal or regulatory advice.