Swissmedic Updates Guidance on Export Certificates for Medical Devices
Swissmedic has updated its guidance on export certificates for medical devices, including eligibility, ordering requirements, product lists, CE conformity documentation, swissdamed registration and fees.
Swissmedic Updates Guidance on Export Certificates: Key Implications for Medical Device Manufacturers
Swissmedic has released updated guidance on the requirements for obtaining export certificates (Free Sales Certificates) for medical devices, introducing clearer rules for manufacturers on documentation, conformity evidence, product grouping, and submission procedures. The revised framework is essential for manufacturers exporting devices to global markets that require FSCs as part of their regulatory registration.