CH-Importer: What is it and who needs it? A CH-Importer is a natural or legal entity based in Switzerland responsible for importing medical devices into the country. While the CH-REP holds regulatory responsibility, the CH-Importer ensures that imported products comply with Swiss regulations and are properly placed on the market. Why is a CH-Importer required?  Ensuring Compliance: The CH-Importer verifies that products meet the requirements of the Medical Devices Ordinance (MedDO).  Product Traceability: The CH-Importer documents imported medical devices and ensures they can be recalled in case of safety concerns.  Collaboration with CH-REP and Authorities: The CH-Importer works closely with the CH-REP and relevant authorities to comply with all regulatory requirements. Who needs a CH-Importer?  Non-Swiss Manufacturers: These require a CH-Importer if they do not have a direct presence in Switzerland.  Distributors and Retailers: If they import medical de...