Obligations and Responsibilities of the Swiss Authorised Representative – CH REP
This whitepaper describes the obligations and responsibilities of the Swiss Authorised Representative (CH REP), roles required by Swiss regulations to market Medical Devices in the territory.
1.INTRODUCTION
Since 2021, following the non-ratification of the mutual recognition agreement, Manufacturers based outside Switzerland have been obliged to appoint an Authorised Representative located in Switzerland, before marketing Medical Devices in Switzerland, also known as CH REP. […]
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