swissdamed fegistration fee

swissdamed fegistration fee

New Registration Requirement for Medical Devices: What Applies from July 2026

As of July 1, 2026, medical devices on the Swiss market must be registered in the national database swissdamed. Swissmedic has now announced the fee structure – with a manageable basic fee and a clear cost cap for larger manufacturers.

Fees at a Glance

  • CHF 200 – Initial registration (first product per year)
  • CHF 20 – Each additional UDI-DI
  • CHF 10,000 – Annual maximum per manufacturer (no further costs from 492 products onwards)

Timeline

July 1, 2026
Registration requirement comes into force. All products with the status “On the market” must be registered in swissdamed.

December 31, 2026
Reference date for fee calculation. Products declared as “No longer placed on the market” by this date remain free of charge.

January 2027
First invoices will be sent. After that, billing will occur on an ongoing basis for new registrations; a new fee period begins with each calendar year.


Important to Know

  • Fees apply per manufacturer – not per CH-REP. Multiple CH-REPs of the same manufacturer are counted together.
  • Updates to existing entries are possible at any time free of charge.
  • If a “discarded” product is reregistered, a fee will apply again.

Source: Swissmedic – swissdamed registration fee

Ugur Müldür

Ugur Müldür leads Sales & Marketing activities at Europe IT Consulting GmbH in Basel, Switzerland. With an industrial engineering background, he bridges regulatory requirements, business needs, and IT implementation for UDI programs. He works with MedTech manufacturers to improve data quality, streamline submissions, and operationalize UDI solutions across global regulations.