MDSS CH GmbH is an Authorized Representative (CH-REP) for medical devices and in vitro diagnostic devices, serving as the formal contact for competent authorities and overseeing registration, vigilance reporting and other regulatory compliance tasks.
Authorized representative for medical devices and IVDs, registration with Swissmedic and Swissdamed, review of technical documentation, reporting of incidents, recalls and non-conforming products.
Free Sales Certificate (FSC / CFS)
Application for Free Sales Certificates, Certificate of Free Sale and Certificate of Marketability for export to more than 60 countries, including notarisation and legalisation requirements.
National product registration
National product registrations in EU member states with additional reporting obligations, including EUDAMED and authority registrations, as well as GMDN code research.
EU Authorized Representative (EC REP)
EU authorized representative for medical devices and IVDs, mandate for manufacturers outside Europe, support with MDR and IVDR requirements, and EU registration.
UK Responsible Person (UKRP)
UK authorized representative for medical devices and IVDs, MHRA registration, technical documentation, evidence of conformity and support for manufacturers outside the United Kingdom.
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