|
Switzerland Medical Device Regulation refers to the framework of laws and requirements governing the approval, market access, and post-market surveillance of medical devices in Switzerland. Following the country’s non-alignment with the European Union’s Medical Device Regulation (EU MDR) after May 2021, Switzerland established its own independent regulatory pathway through the Swissmedic authority. Manufacturers from outside Switzerland are now required to appoint a Swiss Authorised Representative (CH-REP) for placing devices on the Swiss market.
|