Swissmedic Announces Medical Device Registration Fees for swissdamed
Written by: Manuel Mateos CEO and Regulatory Affairs Director, CMC Medical Devices & Drugs S.L.
Swissmedic has published further details on the registration fees that will apply to medical devices, systems and procedure packs registered in the swissdamed database ahead of the mandatory registration requirements coming into force on 1 July 2026.
According to the authority, all devices, systems and procedure packs placed on the Swiss market from that date must be registered in the UDI Devices module of swissdamed, with a transitional period remaining in place until 31 December 2026.
Registration Fee Structure
Swissmedic has confirmed the following fee model for device registration:
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CHF 200 for the first device per year and CHF 20 for each additional device
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A maximum of CHF 10,000 per year per manufacturer / person who assembles systems or procedure packs (no additional costs for 492 devices or more per year)
When do the fees first become payable?
Swissmedic highlighted several important considerations for economic operators:
- On 31.12.2026 for all UDI-DIs with the status ‘On the market’
- No fee if the device is marked as ‘No longer placed on the market’ as at 31.12.2026
The registration requirement applies to all products sold in Switzerland.
Invoicing
Key information on fee payment and invoicing timelines has now been confirmed by Swissmedic.
- First invoice for devices registered up to 31 December 2026 will be issued in January 2027
- Followed by regular invoicing for new registrations
- New calendar year = new fee calculation
Key Points for Manufacturers
Swissmedic highlighted several important considerations for economic operators:
- Fees are charged per manufacturer or person assembling systems and procedure packs
- Updates to existing device data are free of charge
- A fee is payable for the new registration of a device that was “discarded”
Prepare for swissdamed Now
With mandatory registration starting on 1 July 2026 and the transition period ending on 31 December 2026, medical device companies should begin preparing their registration strategy, reviewing device portfolios and ensuring their data is ready for compliance.Need support with medical device registration in Switzerland? Contact our experts to ensure a smooth and compliant registration process.
