CH-Importer Requirements in Switzerland:
Non-Swiss distributors and medical device dealers who want to sell medical devices or IVDs directly into Switzerland must ensure that a Swiss-based importer is involved when products are first placed on the Swiss market from abroad. Under the Swiss Medical Devices Ordinance (MedDO) and the Ordinance on In Vitro Diagnostic Medical Devices (IvDO), the Swiss Importer (CH-Importer) is an economic operator established in Switzerland that places devices from another country on the Swiss market.
The Swiss Importer may only place compliant medical devices and IVDs on the market and must verify the applicable regulatory requirements before doing so. Importer obligations include regulatory verification, identification as the Swiss Importer, traceability and record keeping, as well as supporting complaints, non-conforming devices, recalls, withdrawals and corrective actions.
Swiss Importers also have obligations in swissdamed, the Swiss database on medical devices. Importers do not register devices themselves. Instead, their importer actor is linked to devices that have already been registered in swissdamed in accordance with the applicable Swissmedic requirements and deadlines.
CHREP.me provides Swiss Importer (CH-Importer) services for non-Swiss distributors and medical device dealers who want to sell their products in Switzerland without establishing their own Swiss company. Our streamlined process and transparent pricing provide a simple and cost-efficient route to compliant Swiss market access.
