The swissdamed mandate
Mandatory swissdamed registration from 1 July 2026, transition until 31 December 2026 — with no grace for incident-reporting devices.
Free field guide · PDF
Switzerland Swissmedic Medical Device Registration2026 Field Guide
The swissdamed mandate, the CH-REP rule, and the third-country reality — with the market-access implications.
- Mandatory swissdamed
- 1 Jul 2026
- Transition ends
- 31 Dec 2026
- Mandatory AR
- CH-REP
Sourced from Swissmedic guidance and verified 2026 publications.
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What's inside
Five pages, zero fluff
Every figure in this guide traces to a named source — Swissmedic guidance and verified 2026 publications.
The CH-REP rule
Every non-Swiss manufacturer — including EU and US makers — needs a CH-REP. Switzerland is a third country for devices.
Market-access implications
MedDO vs. EU MDR divergence, UDI data requirements, and why legacy-portfolio coverage matters now.
Sources & scope
- swissmedic.ch, New in swissdamed: Medical device registration now available (Aug 2025).
- swissmedic.ch, Notification of IVDs — registration obligation, Art. 90 IvDO.
- pharmavibes.co.uk, International regulatory news in brief (Oct 2026).
- baerkarrer.ch, Healthcare — Medical Devices 2026.
This guide is market-access intelligence, not regulatory or legal advice. Swissmedic timelines, guidance, and review practice change — professional review is required before business use.
Market Access Strategy Session
Switzerland on your roadmap? Start with the full picture.
A Market Access Strategy Session maps your Swissmedic route — CH-REP appointment, swissdamed registration, and MedDO gap analysis.
Professional review is required before business use.
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