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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 CH-REP (Swiss Authorized Representative) and, in many cases, a CH-Importer to comply with the Swiss Medical Devices Ordinance (MedDO) and In Vitro Diagnostic Ordinance (IvDO).
A CH-REP 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 CH-REP, manufacturers outside Switzerland cannot legally place their products on the Swiss market.
A CH-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 CH-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 CH-REP and CH-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 CH-REP and CH-Importer solutions can support your business in Switzerland.
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