CH-Importer in swissdamed: Link Your Devices by 1 April 2027
Since 1 October 2026, Swiss importers can link their registration to the medical devices and IVDs they place on the Swiss market in swissdamed. Swissmedic gives importers until 1 April 2027 to complete these links. Here is what a CH-Importer has to do now, and what manufacturers should prepare.
Importers link, they do not register
A CH-Importer does not register devices in swissdamed. Devices are registered by Swiss manufacturers or, for foreign manufacturers, by their Swiss Authorised Representative (CH-REP). The importer then adds its own details to an already registered device by linking its CHRN (CHRN-IM-…) to the device's UDI-DI.
The legal basis is Art. 53 para. 4 MedDO and Art. 46 para. 4 IvDO, each in conjunction with Art. 13 para. 4 of the EU MDR or IVDR. Linking is free of charge for importers.
Key dates
| Date | What applies |
|---|---|
| 1 July 2026 | Device registration in swissdamed is mandatory |
| 1 October 2026 | Linking function for importers is available |
| 31 December 2026 | End of the transitional period for device registration |
| 1 April 2027 | All imported devices must be linked; after this date, no delay between placing on the market and linking is accepted |
| 1 November 2028 | Later deadline for spectacle frames, spectacle lenses and ready-to-wear reading glasses |
Until 1 April 2027, Swissmedic will not take enforcement measures solely because a link is missing.
How the linking works
- The link is based on the UDI-DI of the device.
- A device can only be linked once it is registered in swissdamed with the status "On the market".
- UDI-DIs can be linked one by one or by bulk upload of up to 1,000 UDI-DIs per operation.
- A link can be undone with the unlink function.
- The importer must keep its contact details in the swissdamed Actors module up to date.
What to check before linking
As part of its general conformity checks, the CH-Importer verifies the device documentation. In practice, three checks prepare the link:
- The UDI-DI is shown correctly on the label or packaging.
- The Basic UDI-DI on the manufacturer's declaration of conformity matches the device.
- The UDI-DI can be found in the public swissdamed device search with the status "On the market". If not, contact the manufacturer or its CH-REP: their registration deadline is 31 December 2026.
Free Swissmedic webinar on 10 November 2026
Swissmedic runs a free online training on Tuesday, 10 November 2026, from 14:00 to 15:30 Swiss time, in English. Topics include device registration, linking as an importer, fees and device transfer. Places are limited, so registration via the Swissmedic event page is required. A recording will be published on the Swissmedic website afterwards.
Conclusion
Each link takes only a few clicks, but importers with long product lists should plan ahead. Collect the UDI-DIs per manufacturer, confirm they are registered, then link them in bulk well before 1 April 2027.
Sources
- Swissmedic: Importers (swissdamed)
- Swissmedic: swissdamed questions and answers
- Swissmedic: swissdamed webinar 10 November 2026
- Medical Devices Ordinance (MedDO, SR 812.213)
- In Vitro Diagnostic Medical Devices Ordinance (IvDO, SR 812.219)
Need a Swiss Importer?
CHREP.me acts as your Swiss Importer (CH-Importer) and Swiss Authorised Representative (CH-REP) for medical devices and IVDs. New to the topic? Read What is a CH-Importer? Who needs it? Have a question first? Book a callback or contact us – we reply in English and German.
