Medical Device Registration Requirements
Due to larger political issues, the Switzerland-EU Mutual Recognition Agreement has lapsed for medical devices and IVDs. As a result, Swissmedic no longer has Competent Authority access to EUDAMED.
In the meantime, Swissmedic is developing its own EUDAMED-like medical device registration database, called ‘swissdamed’. Its mandatory use dates are:
- Economic Operators (manufacturers, system/procedure pack producers, authorized representatives, importers) – August 6, 2024
- Medical Devices and IVDs – July 1, 2026
Until the swissdamed registration database is launched, only a limited number of medical devices require registration in Switzerland.
The current registration requirements are outlined below. For the detailed overview and application forms, please refer to Swissmedic’s website: medical devices, IVDs
Class I Medical Devices
Only applicable to Swiss manufacturers; Swiss Authorized Representatives (CH-REPs) are not obligated to notify Class I devices on behalf of third country (i.e., non-Swiss) manufacturers, although the CH-REP is obligated to verify that the device complies with the Swiss medical device ordinance (MedDO).
IVDs
Only applicable to Swiss manufacturers; Swiss Authorized Representatives (CH-REPs) are not obligated to notify IVD medical devices on behalf of third country (i.e., non-Swiss) manufacturers, although the CH-REP is obligated to verify that the device complies with the Swiss medical device ordinance (IvDO).
Systems/Procedure Packs
Only applicable to assemblers based in Switzerland; Swiss ARs are not obligated to notify system/procedure packs on behalf of third country manufacturers.
Custom-made Devices
Required for all custom-made devices. The registration is made by the manufacturer, authorized representative (CH-REP), importer or distributor in Switzerland before making the product available on the market.
Manufacturer Registration Requirements
Like Europe, Switzerland requires the registration of economic operators, e.g., manufacturers and system/procedure pack producers.
However, unlike the EU MDR/IVDR, which requires that all manufacturers and system/procedure pack producers register in EUDAMED, Swissmedic only requires Swiss manufacturers and system/procedure pack producers to register. They are then issued a Swiss Single Registration Number, abbreviated as CHRN (“CH” being the country abbreviation for Switzerland).
NOTE: the Swiss Authorized Representative is required to add all the non-Swiss companies they represent in their swissdamed account. The non-Swiss manufacturers are then assigned a Mandate ID and are added to ‘swissdamed’.
Medical device/IVD Registration Fee
Not all manufacturers / devices have to be registered in Switzerland. Please refer to the above section to see which devices require registration.
If your device does require registration, Swissmedic charges a fee of CHF 300 per notification. An additional administrative fee of CHF 200/hour may be charged, in certain cases. For example, “due to incomplete or inappropriate documentation, withdrawal of a notification after work has already been carried out, requests for information or the correction of a notification as a result of a mistake made by the notifying company.”
Once the swissdamed device registration module becomes mandatory starting July 1, 2026, Swissmedic will charge a fee for registration. However, they have not yet confirmed the amount.
Medical device/IVD Registration Timing
It takes Swissmedic approximately one month to process notifications. However, you may begin marketing the device in Switzerland as soon as the notification is submitted. You do not need to wait for Swissmedic to complete process.
“Processing a notification takes approximately one month from receipt. This assumes that the notification contains all the necessary information and documentation. However, the statutory notification obligation is fulfilled with the submission of the notification.“
