Swissmedic has published Version 2.0 of its Information Sheet “Medical device registration fee”, valid from 27 October 2026.
The document explains how registration fees are calculated and invoiced for medical devices entered in the swissdamed database, including medical devices, IVDs, systems and procedure packs.
Mandatory Registration in swissdamed
Medical devices placed on the Swiss market have been required to be registered in swissdamed since 1 July 2026.
Registration is subject to a fee, which must be paid by the registering manufacturer, person assembling systems or procedure packs, or the relevant Swiss authorised representative where applicable.
Swissmedic confirms that the transition period for completing registration runs until 31 December 2026.
How the Registration Fee Is Calculated
Swissmedic applies a fixed-fee model based on the number of registered UDI-DIs.
For fee purposes, a product is defined by:
the UDI-DI;
the issuing entity;
the applicable legislation under which the device is registered.
Basic Fee
A one-time basic fee of CHF 200 is charged for the first UDI-DI registered in a calendar year by a manufacturer or person assembling systems or procedure packs.
Unit Fee
Each additional UDI-DI registered during the same calendar year is subject to a CHF 20 unit fee.
Maximum Annual Fee
The maximum registration fee is CHF 10,000 per year per manufacturer or person assembling systems or procedure packs.
This limit is reached at 491 registered UDI-DIs:
CHF 200 basic fee;
490 × CHF 20 unit fees.
No further fees are charged from the 492nd UDI-DI registered in that calendar year.
Basic UDI-DI and Package UDI-DI
Swissmedic clarifies that fees are based only on registered UDI-DIs.
No registration fee is charged for:
Basic UDI-DIs;
package UDI-DIs.
Devices Registered During the Transition Period
In principle, devices registered in swissdamed by 31 December 2026 are subject to the registration fee, regardless of whether they were entered during the voluntary phase or after mandatory registration began.
However, no fee is charged for devices that are no longer placed on the market as of 31 December 2026 and are marked in swissdamed with the status “No longer placed on the market.”
Initial Invoicing Starts in January 2027
The first invoices will be issued from January 2027.
Initial billing will cover all UDI-DIs registered up to and including 31 December 2026 that still had the status “On the market” on that date.
Billing in Subsequent Years
After the initial billing cycle, newly registered UDI-DIs will be billed monthly.
Each new calendar year starts a new calculation cycle:
CHF 200 for the first newly registered UDI-DI;
CHF 20 for each additional UDI-DI;
CHF 10,000 annual maximum.
The UDI-DI counter is reset on 1 January each year.
Who Receives the Invoice?
Swiss manufacturers and persons assembling systems or procedure packs receive invoices directly.
For foreign manufacturers, invoices are sent to the relevant CH-REP.
Swissmedic also confirms that a separate invoice is issued for each CH-REP mandate associated with a foreign manufacturer.
Registration Fees for Updates
Swissmedic distinguishes between routine updates and renewed registrations.
If information for an already registered UDI-DI is simply corrected or updated, no new registration fee is charged.
However, if a UDI-DI previously marked as “discarded” is registered again, a new fee applies.
Legacy Devices and MDR/IVDR Transitions
Version 2.0 also clarifies the treatment of legacy devices.
Legacy devices are products certified under previous EU legislation such as:
MDD;
AIMDD;
IVDD.
If a legacy device is newly registered under the MDR or IVDR, Swissmedic considers this a new registration subject to fees, even where the UDI-DI itself remains unchanged.
This is particularly important for manufacturers transitioning existing portfolios to the newer regulatory framework.
Payment Method
Swissmedic recommends payment using the QR pay-in slip.
For international payments, companies should ensure that all bank fees are covered by the sender so that Swissmedic receives the full invoiced amount.
The invoice must be paid within 30 days.
Credit card payments are not accepted.
New Invoicing Dashboard in swissdamed
The guidance also explains the invoicing functionality available in swissdamed.
An “Invoicing” tab is available for:
authorised representatives;
manufacturers;
persons assembling systems or procedure packs;
mandates for foreign manufacturers and foreign system/procedure-pack assemblers.
The tab is not displayed for importer accounts.
Actor Admin Responsibilities
Only users with the Actor Admin role can edit invoicing settings.
Other users with read-only access, such as Actor Viewers or UDI Editors, may view but cannot modify billing information.
Actor Admins can manage:
purchase order numbers;
invoice addresses;
invoice delivery preferences.
Electronic or Postal Invoicing
Invoices can be delivered either:
by email as a PDF;
by post.
If no email address is provided, invoices will automatically be sent by post.
The screenshots on pages 6–8 of the information sheet show how users configure the invoicing dashboard, purchase order details and delivery preferences within swissdamed.
Information Included on Invoices
Swissmedic invoices may include:
CHRN of the actor;
contact person;
invoice period;
purchase order number.
For mandate-related invoices, the SRN and mandate address are also included.
What Changed in Version 2.0?
According to the change history, Version 2.0 introduces:
an additional note in section 5.2.2;
a new definitions section;
new sections covering:
legacy device and MDR transition fees;
payment method and deadlines;
invoice delivery and dashboard functionality.
Impact on Manufacturers and CH-REPs
For manufacturers, persons assembling systems and procedure packs, and CH-REPs, the guidance provides greater clarity on the financial and administrative consequences of swissdamed registration.
Key actions include:
completing registration by 31 December 2026;
reviewing which UDI-DIs remain “On the market” at year-end;
budgeting for the CHF 200 basic fee and CHF 20 unit fee;
assessing legacy device transitions;
configuring invoice delivery settings;
verifying CH-REP mandate arrangements;
ensuring invoices are paid within 30 days.
For companies with large device portfolios, the CHF 10,000 annual cap is also an important factor in registration planning.
