Alcon
Geneva, Switzerland
Geneva-headquartered eye care company with surgical and vision care products.
Business types in Geneva
Regulation in Switzerland
Swiss device rules mirror EU MDR/IVDR; Switzerland unilaterally recognises EU conformity assessment (CE marking), but foreign makers need a Swiss authorised representative.
From the sourced MedDO / IvDO entry, checked 29 October 2026. General information, not legal advice. Requirements for Switzerland · All medical certifications
Frequently asked questions
Does a manufacturer outside Switzerland need a Swiss authorized representative?
Yes. Manufacturers based outside Switzerland, including EU manufacturers, must appoint a Swiss authorized representative (CH-REP) by written mandate, managed in swissdamed. The CH-REP and Swiss importers register as economic operators and receive a Swiss single registration number (CHRN). The CH-REP keeps the technical documentation and declaration of conformity available to Swissmedic and cooperates on vigilance.
Labeling must identify the CH-REP and the importer. If a CH-REP becomes inactive in swissdamed, its mandates are treated as no longer valid. Ask Swiss partners on the Switzerland country page for their CHRN.
What should I verify with a Swiss importer or distributor?
Useful checks for a Swiss partner:
- its CHRN, and whether it acts as importer, CH-REP or both for each brand;
- that the foreign manufacturer's CH-REP mandate is active in swissdamed;
- that labels identify the CH-REP and importer as required;
- that the device is registered in swissdamed, or within the transition period;
- CE marking and, where applicable, the EU notified body certificate that Switzerland recognizes.
Swissmedic publishes guidance on economic operator obligations. Listings on the Switzerland country page are self-described and are not verification of these points.