Accelerate market entry with AI-powered dossier compilation and local representation, all for a flat annual fee. Starting at $2,000 USD per year for the first device (excludes government fees). Includes dossier submission, in-country representation, translation, modifications, distributor authorization, and post-market support.
The Swissmedic swissdamed fees 2026 update introduces mandatory medical device registration in Switzerland from 1 July 2026 under MedDO and IvDO. Devices must be registered in swissdamed and will be subject to annual fees based on UDI-DI counts, with a CHF 200 base fee and CHF 20 per additional device, capped at CHF 10,000 per manufacturer. The regulation aligns Swiss medical device registration with lifecycle-based compliance and introduces a transition period until 31 December 2026.
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