CH-REP Requirements in Switzerland:
Manufacturers established outside Switzerland, including manufacturers based in the EU/EEA, must appoint a Swiss Authorised Representative (CH-REP) before placing their medical devices or IVDs on the Swiss market. The CH-REP must be established in Switzerland and formally appointed through a written mandate. The applicable requirements are defined under the Swiss Medical Devices Ordinance (MedDO) and the Ordinance on In Vitro Diagnostic Medical Devices (IvDO).
The CH-REP acts as the official Swiss representative of the foreign manufacturer and serves as a contact point for Swissmedic and other Swiss authorities. Its responsibilities include supporting compliance with Swiss medical device requirements, keeping required regulatory documentation available, supporting vigilance and incident reporting, and ensuring that CH-REP identification requirements are met.
The name and address of the Swiss Authorised Representative must be identified with the medical device in accordance with the applicable Swiss labelling requirements. In addition, medical devices and IVDs placed on the Swiss market are subject to registration requirements in swissdamed. For foreign manufacturers, the CH-REP can register the required product data in swissdamed.
If you are looking for a CH-REP in Switzerland, CHREP.me provides Swiss Authorised Representative services for non-Swiss medical device and IVD manufacturers. Our streamlined process, transparent pricing and regulatory support make Swiss market access simple and predictable.
