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Switzerland has strict regulatory requirements for medical devices and in vitro diagnostics (IVDs). If you are a non-Swiss manufacturer or distributor looking to sell in Switzerland, you must appoint a Representative and, in many cases, a Importer to comply with the Swiss Medical Devices Ordinance (MedDO) and In Vitro Diagnostic Ordinance (IvDO).
A Representative serves as your official representative in Switzerland, acting as the main point of contact with Swissmedic, ensuring regulatory compliance, maintaining technical documentation, and overseeing post-market surveillance. Without a Representative, manufacturers outside Switzerland cannot legally place their products on the Swiss market.
A Importer, on the other hand, is responsible for importing medical devices and IVDs into Switzerland while ensuring compliance with all Swiss labeling, registration, and regulatory requirements. The Importer verifies that products meet the required standards before they enter the market, reducing compliance risks and ensuring a smooth importation process.
Navigating these complex regulations can be challenging, but our expert Representative and Importer services simplify the process. We handle all regulatory requirements, help you avoid costly mistakes, and ensure your medical devices reach the Swiss market efficiently.
With years of experience in regulatory compliance, we provide a trusted and professional service tailored to your needs. Contact us today to learn how our Representative and Importer solutions can support your business in Switzerland.
Switzerland imposes high regulatory requirements for the distribution of Medical Devices and In Vitro Diagnostic Medical Devices (IVDs). If you are a non-Swiss manufacturer or distributor planning to sell your products in Switzerland, you are obligated to designate a Representative (Swiss Authorised Representative) and – in many cases – a Swiss Importer (Importer). These requirements are based on the Swiss Medical Devices Ordinance (MedDO) and the In Vitro Diagnostic Medical Devices Ordinance (IvDO).
The Representative acts as the official representative of your company in Switzerland. They are the central contact person for Swissmedic, monitor compliance with regulatory requirements, manage technical documentation, and undertake market surveillance tasks. Without a designated Representative, manufacturers outside Switzerland are not permitted to legally distribute their products on the Swiss market.
The Swiss Importer, on the other hand, is responsible for the import of your products into Switzerland, ensuring that all labeling, registration, and language specifications, as well as regulatory requirements, are met. They verify that your products comply with legal standards even before they are placed on the market. Adhering to these complex regulations can be challenging – we are here to support you with this.
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