Certain countries do not recognise the European CE conformity marking system for medical devices, and – for the purposes of import, authorisation and distribution in their country – demand an export certificate or other certificate issued by the competent authority at the exporting company's registered place of business.
Swissmedic issues such export certificates and other certificates for the export of medical devices to third countries to persons domiciled in Switzerland, provided they present the necessary evidence.
Export certificates (Free Sales Certificates, FSC) certify the formal conformity of the medical devices in question with the legal requirements in Switzerland and thus their basic eligibility for being marketed at the time the certificate is issued.
The Manufacturing Certificate (MC) certifies that a Swiss contract manufacturer operates a certified quality management system and manufactures medical devices for a medical device manufacturer (domiciled in Switzerland or abroad).
Other certificates inform foreign authorities about particular facts relating to medical devices.