Today Swissmedic published an update regarding its new registration database:

Swiss Database on Medical Devices (Swissdamed)

Current Registration Requirements (for frame of reference)

Swiss-based manufacturers, authorized representatives and importers (“economic operators”) must register themselves with Swissmedic. They will then be issued a Swiss Single Registration Number (CHRN), which is the Swiss version of the European Single Registration Number (SRN).

While obtaining a European SRN is currently voluntary, obtaining a CHRN is mandatory.

However, non-Swiss manufacturers are not required, nor allowed, to obtain a CHRN. The requirement only applies to Swiss-based economic operators. 

Swissmedic does require registration for certain medical devices, but only from Swiss-based* manufacturers. For example, Class I devices must be registered – but only if the manufacturer is Swiss. If the manufacturer resides outside of Switzerland, neither they, nor their appointed Swiss Authorized Representative, are required to register the Class I device.

*The exception is for custom-made devices, which require registration irrespective of where the manufacturer is located.

For more information on this topic, please read: Switzerland Registration Requirements

Overview of Swissdamed

The launch of Swissdamed will introduce a new registration system, which will be aligned with EUDAMED:

• • The ‘go-live’ is planned for 2023
  • It will consist of two modules, plus the public website
  • Swissdamed will be rolled out in three phases:
    1. Economic Operator Registration module
    2. Medical Device & IVD Registration module
    3. Additional functionality for the above modules
  • Swissdamed’s modules will be similar to the corresponding EUDAMED Economic Operator and medical device registration modules
  • Economic Operators who have already registered with Swissmedic will not have to register again; their original registrations will be rolled into the new system

Registration will only become mandatory once Swissmedic amends the Medical Device Ordinance (MedDO) and In Vitro Diagnostic Device Ordinance (IvDO).

We will report as more information is released on Swissdamed and Swiss registration requirements.

For more information about how Casus can support in Switzerland, please read: Swiss Authorized Representative