Today Swissmedic published an update regarding its new registration database:
Swiss Database on Medical Devices (Swissdamed)
Today Swissmedic published an update regarding its new registration database:
Swiss Database on Medical Devices (Swissdamed)
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
The launch of Swissdamed will introduce a new registration system, which will be aligned with EUDAMED:
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