Dental Instruments Manufacturers in Switzerland

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 If a CH-REP becomes inactive in swissdamed, its mandates are treated as no longer valid.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.

Switzerland

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.

Switzerland