Certain countries do not recognize the European CE conformity marking for medical devices - for the purpose of import, authorization and distribution in their country - demand an export certificate (Free Sales Certificate, FSC) issued by the competent authority at the exporting  company's registered place of business. FSCs confirm the formal conformity of the medical devices in question with the legal requirements in Liechtenstein and thus their basic eligibility for being marketed at the time the certificate is issued. 

The Office of Public Health issues such FSCs for the export of medical devices to third countries to manufacturers and authorized representatives domiciled in Liechtenstein, provided they present the necessary evidence. The certificates are issued exclusively in English.

Ordering an FSC

Manufacturers and authorized representatives based in Liechtenstein can order FSCs from the Office of Public Health by submitting the following documents (by e-mail to: medical.devices@llv.li):

• Order form for export certificates
• Declarations of conformity from the legal manufacturer
• EC certificates of conformity, incl. any annexes
• Product list, which is part of the FSC and is stamped by the Office of Public Health. The following requirements must be observed: 
  • Information in English
  • PDF format, formatting: A4, page margins at least 2 cm (top, bottom, left, right)
  • with the letterhead of the applicant vompany (full company name and address)
  • consecutive page numbering (e.g. "page 1 of 1", "page 1 of 10", "page 2 of 10" etc.) 
  • Minimum information per medical device: reference or article number, product name, class, Basic UDI-DI (for MDR and IVDR products), GMDN code (or code of another recognized nomenclature)

Processing deadlines

FSCs are issued by the Office of Public Health within 30 days of receipt of the order and electronic submission of the complete and appropriate documentation.

Fees

The issue of an FSC costs CHF 200.-. If several identical certificates are ordered with one order, CHF 100.- will be charged for each additional identical certificate.