Swissmedic swissdamed Fees 2026 Update and New Rules

The Swissmedic swissdamed fees 2026 update introduces a major regulatory shift in Switzerland’s medical device framework. From 1 July 2026, registration in swissdamed becomes mandatory under the new MedDO and IvDO regulations, replacing the previous notification system. This change introduces annual fees for each registered device and applies to all medical devices placed on the Swiss market, including systems and procedure packs. Understanding these changes is essential for manufacturers preparing for Switzerland medical device compliance and post-market obligations.

Key Regulatory Changes in Swissmedic swissdamed 2026 Update

The Swiss medical device framework is transitioning from a notification-based system to a legally binding registration model. Under the updated rules from Swissmedic, all devices must be registered in the national database swissdamed starting 1 July 2026.

Key changes include:

• Mandatory registration for all medical devices on the Swiss market  

• Inclusion of systems and procedure packs  

• Extension of responsibility to manufacturers and assemblers  

• Transition period until 31 December 2026  

After this period, only fully registered devices will remain compliant.

Swissmedic swissdamed 2026 Fee Structure

From 2026 onward, Swissmedic will apply annual fees per registered UDI-DI.

Fee model:

• CHF 200 for the first device per year  

• CHF 20 for each additional device  

• Maximum CHF 10,000 per manufacturer or assembler per year  

This means large portfolios benefit from a capped fee structure, limiting total annual exposure even for high-volume manufacturers.

How swissdamed Fees Are Calculated

Fees are calculated based on:

• Each UDI-DI registered in swissdamed  

• Manufacturer or assembler (not CH-REP level)  

• Annual cumulative device count per organization  

Important rules:

• Updates to existing records are free of charge  

• No fee applies for devices marked “No longer placed on the market” by 31.12.2026  

• Fee cap applies regardless of portfolio size  

Billing Timeline and Transition Period

Swissmedic has defined a clear transition structure:

• Devices registered up to 31 December 2026 → invoiced in January 2027  

• First consolidated invoice covers transition registrations  

• Annual billing applies from 2027 onward  

• New calendar year resets fee calculation  

This ensures manufacturers have time to complete registration while preparing for recurring costs.

Compliance Impact for Manufacturers

The Swissmedic swissdamed 2026 update introduces both operational and financial implications:

Key impacts:

• Increased importance of accurate UDI-DI management  

• Need for portfolio optimization and lifecycle tracking  

• Shift of compliance responsibility to manufacturers and assemblers  

• New recurring cost planning requirement  

Manufacturers with large product portfolios should assess whether all registered devices remain actively marketed in Switzerland.

Action Steps for Regulatory Teams

To prepare for full enforcement, manufacturers should:

1. Audit product portfolios

Identify all devices intended for the Swiss market.

2. Complete swissdamed registration early

Avoid last-minute submission risks before 31 December 2026.

3. Review lifecycle status

Mark discontinued devices appropriately to avoid unnecessary fees.

4. Forecast annual costs

Estimate fees using CHF 200 + CHF 20 per additional device model.

5. Align regulatory and finance teams

Ensure budgeting includes post-2027 recurring swissdamed fees.

Internal References

• Swissmedic Switzerland Medical Device Registration

External References

• Swissmedic swissdamed overview

• Swissmedic registration fees official page
  

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