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A Swiss Authorized Representative (CH-REP) is a mandatory legal requirement for non-Swiss manufacturers who wish to market medical devices in Switzerland. Following the implementation of the revised Swiss Medical Device Ordinance (MedDO) after Switzerland’s exclusion from the EU MDR agreement in May 2021, all foreign manufacturers must appoint a local representative based in Switzerland to ensure regulatory compliance. The Swiss Authorized Representative acts as the official point of contact with Swissmedic, the country’s regulatory authority, and is responsible for maintaining technical documentation, reporting incidents, and ensuring post-market surveillance obligations are met.
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