News about GMP/cGMP

07.12.2021

Swissmedic: Registration required for medical product manufacturers

Swissmedic: Registration required for medical product manufacturers

To ensure market surveillance of medical devices, manufacturers, authorized representatives and importers based in Switzerland must register with Swissmedic within three months of first placing a product on the market. This was revealed in a Swissmedic announcement in late November.
After the applicants have undergone the process, they will be assigned an individual Swiss identification number, the Swiss Single Registration Number (CHRN).


As already reported in our news of 28 May 2021, a total revision of the Medical Devices Ordinance MepV was carried out in Switzerland in response to the European Medical Device Regulation (EU MDR). As a result of the correction, a revision of the MRA (Mutual Recognition Agreement) between Switzerland and the EU also became necessary. Negotiations have currently been broken off.
The agreement was supposed to ensure joint monitoring as well as uninhibited market access for both sides. As long as the MRA is not implemented, Swissmedic has no access to the central European database for medical devices (EUDAMED).


Source:

Swissmedic

Unique identification number

Service agreement for CHRN

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