What manufacturers can expect from 2027 onwards
Since 1 July 2026, all medical devices placed on the Swiss market are subject to a mandatory registration requirement in the swissdamed database. This mandatory registration is also subject to a fee! As your Swiss Authorised Representative (CH-REP), we would like to inform you of the key points so you can plan for the associated costs in advance.
How much is the fee?
The product registration fee consists of the following components:
- 200 CHF base fee for the first UDI-DI registered in a calendar year
- 20 CHF per-unit fee for each additional UDI-DI registered in the same year
- Maximal 10,000 CHF per calendar year – this cap is reached at 491 registered UDI-DIs; no additional costs apply to any further products registered in the same year
Example calculation: For 50 registered UDI-DIs, the fee amounts to CHF 200 + 49 × CHF 20 = CHF 1,180 for that year.
The CHF 10,000 cap applies per manufacturer, regardless of how many other mandates we manage as your CH-REP.
Important: Previously completed registrations are also included
The voluntary registration phase in swissdamed ran from 18 August 2025 to 30 June 2026 and was free of charge at that time. However, the new fee applies retroactively to all products registered up to 31 December 2026that have the status "On the market" at that point in time – regardless of when the registration actually took place The only exception applies to products that are marked in swissdamed with the status "No longer placed on the market" by the end of 2026. No fee applies to these.
When and how will invoicing take place?
- The first invoicing will take place from January 2027 onwards and will cover all UDI-DIs registered up to 31 December 2026
- From the following year onward, newly registered UDI-DIs will be invoiced monthly abgerechnet
- A new calculation cycle begins at the start of each calendar year (1 January): the UDI-DI counter is reset, and the base fee applies again to the first registration of the year
- Since we act as your CH-REP, we will receive the invoice directly from Swissmedic and will have to pass on the corresponding costs to you - but with us, there's no extra charge!
Good to know
- Simply updating data for an already registered UDI-DI (e.g. manual corrections or re-uploading an XML file) does not trigger a new fee
- If a UDI-DI is marked as "discarded" and later re-registered, a fee will apply again upon re-registration
Our recommendation
Wir empfehlen, gemeinsam mit uns frühzeitig zu klären, wie viele UDI-DIs für Ihre Produkte registriert werden müssen bzw. bereits registriert sind, damit die zu erwartenden Kosten für
Our recommendation
We recommend clarifying together with us, at an early stage, how many UDI-DIs need to be registered for your products or have already been registered, so that the expected costs for 2027 can be realistically estimated. If you have any questions about your individual situation, we are happy to help.
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