Switzerland makes medical device registration mandatory in swissdamed
Medical device companies must register Swiss-market devices in swissdamed from 1 July 2026 or lose Swiss-market compliance
SECO
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Change
On 27 May 2026, the Swiss Federal Council approved a revision to the Swissmedic Fees Ordinance (FeeO-Swissmedic) introducing a medical device registration fee and making swissdamed registration mandatory from 1 July 2026, with a transitional period until 31 December 2026.
Why it matters
The revision makes swissdamed registration a mandatory requirement for placing medical devices on the Swiss market, with a transitional period to 31 December 2026. Companies must prepare device and company registration data and budget for the new Swissmedic fee. The ordinance also raises the time-based hourly rate for inflation — unchanged since 2002 — increasing the cost of fee-bearing Swissmedic services charged on a time basis.
Implications
- — Medical device manufacturers, importers, and Swiss authorised representatives placing devices on the Swiss market must register their devices and responsible-company details in the swissdamed database from 1 July 2026, completing registration within the transitional period ending 31 December 2026 — devices not registered after the transitional window are non-compliant for the Swiss market.
- — Regulatory affairs and market-access teams must budget for the new device registration fee under the revised FeeO-Swissmedic and incorporate it into Swiss market-access cost models — the fee is a new cost of placing devices on the Swiss market that did not previously exist.
- — Compliance and RA teams must map their full Swiss device portfolio against swissdamed registration requirements now and sequence registrations before the 31 December 2026 cut-off — back-loading registrations to the deadline risks processing delays that leave devices non-compliant at year-end.
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