MDSS GROUP
SWISS AUTHORIZED REPRESENTATIVE
(CH REP)
The Swiss Authorized Representative is required by the Swiss Authorities for Medical Devices Manufacturers located outside of Switzerland. In order to place medical devices in the Swiss market, you need to appoint a Swiss Authorized Representative (CH-REP).
As your CH-REP we will guide you through the Swiss requirements ensuring you are in compliance with the Swiss Regulation.
Timelines
High-risk devices (Class III, IIb implantable and AIMD)
Moderate-risk devices (non-implantable Class IIb, Class IIa)
Low-risk devices (Class I)
Systems and procedure packs
31 December 2021
31 March 2022
31 July 2021
31 July 2022
