In August 2025, Swissmedic – the Swiss Agency for Therapeutic Products – announced that the new UDI devices module in Swissdamed is live. The UDI Devices module allows the registration of medical devices and IVDs placed on the Swiss or Lichtenstein market.
Swissdamed implementation timeline
Starting 1 July 2026, registering medical devices, in vitro diagnostic medical devices, as well as systems and procedure packs in the UDI module will become mandatory for products placed on the Swiss market. A transitional period will remain in effect until the end of 2026. However, devices subject to a reporting obligation for serious incidents, field safety corrective actions, or trend will have to be registered by 1 July 2026, with no transitional period.
The actor module has been available from August 2024. Manufacturers based in Switzerland or Lichtenstein, as well as importers, and authorised representatives, are required to register through the Swissdamed website and obtain the CHRN (Swiss Single Registration Number).
Registration of devices for non-Swiss manufacturers
While the registration is possible only for actors based in Switzerland or Lichtenstein, devices sold by other manufacturers must still be displayed in Swissdamed. In this case, foreign manufacturers that sell in Switzerland or Lichtenstein must have their mandate linked to a Swiss authorised representative.
As your Swiss authorised representative, Obelis Swiss takes care of verifying your registration obligations and links the relevant mandate to the authorised representative’s actor profile.
From May 2022, all manufacturers based outside of Switzerland or Lichtenstein must manufacturers designate a Swiss-based authorised representative. This also includes companies based in the European Union.
In Europe or in the US, Obelis can support your market access. Contact us today here.
Regulatory Intelligence & Innovation
21/08/2025
Reference:
Swissmedic (2025). New in swissdamed: Medical device registration now available.
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