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Swissmedamed Readiness Check

Check whether your actor and product registrations in Swissmedamed are correctly set up under the Swiss Medical Devices Ordinance (MedDO, SR 812.213). Swissmedamed is independent of EUDAMED; EU registration does not cover the Swiss market.

Question 1 of 5

Have you appointed a Swiss authorized representative (CH-REP) for the Swiss market?

CH-REP obligation, MedDO (SR 812.213) Art. 56.

Orientation only, not a substitute for a regulatory assessment.

Need support with implementation?

The tool provides initial guidance. For your specific situation, we clarify the right approach in a first call.