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swissdamed

MedTech Current publications and recall entries tagged swissdamed.

Regulatory Intelligence3 September 2026

Swissmedic Publishes Its First Fees Ordinance FAQ as swissdamed Device-Registration Fees Take Effect

Swissmedic has published its first FAQ on enforcement practice under the Swissmedic Fees Ordinance, effective from 1 September 2026. For medical-device companies, the FAQ sits alongside the already-effective swissdamed registration regime, under which device registration became mandatory on 1 July 2026 and registration fees are charged per UDI-DI.

Regulatory Intelligence22 August 2026

swissdamed Device Registration Is Now Mandatory — but the Deadlines Differ by Role and Situation

Mandatory device registration in swissdamed began on 1 July 2026, with a general transition period through 31 December 2026. Economic-operator CHRN registration predates this milestone, while devices involved in serious incidents, FSCAs, or trend reporting must be registered immediately without using the transition period.