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Swissmedic Publishes Its First Fees Ordinance FAQ as swissdamed Device-Registration Fees Take Effect

Swissmedic has published its first FAQ on enforcement practice under the Swissmedic Fees Ordinance, effective from 1 September 2026. For medical-device companies, the FAQ sits alongside the already-effective swissdamed registration regime, under which device registration became mandatory on 1 July 2026 and registration fees are charged per UDI-DI.

By MedTech Current

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Swissmedic has published its first FAQ on fee-charging practice

Swissmedic published its first Frequently Asked Questions on enforcement practice under the Swissmedic Fees Ordinance on September 1, 2026.

The Agency states that the FAQ is intended to explain its fee-charging practice and help affected applicants understand how the ordinance is applied. The initial list contains three questions and is expected to be expanded over time.

For medical-device companies, this update should be read together with the separate swissdamed registration and fee rules that already took effect on July 1, 2026.

The swissdamed registration obligation did not start on September 1

Medical devices, systems, and procedure packs became subject to mandatory registration in swissdamed from July 1, 2026, with a transition period through December 31, 2026 for applicable existing products.

The September FAQ does not create a new swissdamed registration deadline.

It is an administrative clarification on charging practice under the Fees Ordinance.

Device registration fees are already operational

Swissmedic states that device-registration fees are charged per UDI-DI.

For each manufacturer or person assembling systems or procedure packs, the first device registered in a calendar year is charged CHF 200 and each additional newly registered device is charged CHF 20.

The annual cap is CHF 10,000 per manufacturer or system/procedure-pack assembler.

For foreign manufacturers, invoicing is issued to the Swiss authorised representative.

For 2026, Swissmedic states that the first fees become payable based on UDI-DIs with the status “On the market” as of December 31, 2026.

Some products cannot rely on the transition period

The general transition period runs through December 31, 2026.

However, immediate registration applies from July 1, 2026 for devices and systems or procedure packs for which a serious incident, field safety corrective action, or trend must be reported to Swissmedic.

That distinction should be reflected in post-market and vigilance workflows.

What companies can check

  • Confirm that devices continuing on the Swiss market are scheduled for swissdamed registration by the end of the transition period.
  • Estimate the 2026 registration-fee impact using the number of UDI-DIs expected to remain “On the market” at year-end.
  • Define responsibility between foreign manufacturers and CH-REPs for registration, invoicing, and data maintenance.
  • Make sure vigilance-triggered devices are not incorrectly treated as eligible for the general transition period.
  • Verify the current Swissmedic Fees Ordinance rates for any time-based work relevant to regulatory budgets.

For medical-device teams, the operational issue is now execution. The database obligation is already in force; the September FAQ adds more clarity on how Swissmedic applies the related fee framework.

Sources

  1. Primary official source1 September 2026 – New: FAQ on Swissmedic Fees OrdinanceSwiss Agency for Therapeutic Products
  2. Supporting sourceFrequently Asked Questions Fees OrdinanceSwiss Agency for Therapeutic Products
  3. Supporting sourceRegistration feeSwiss Agency for Therapeutic Products
  4. Supporting sourceDeadline for Device Registration in swissdamedSwiss Agency for Therapeutic Products