Free Sales Certificates (FSC)

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. 

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

Ordering Export Certificates (Free Sale Certificates, FSC)

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

• Order Form
• Declarations of Conformity from the legal manufacturer
• Certificates of CE conformity, including any attachments
• Product list

Product list

The product list is part of the FSC and is stamped by the Office of Health. The following specifications must be observed:

1.  In English
2.  PDF format, formatting: A4, page margins at least 2 cm (top, bottom, left, right)
3. with letterhead of the requesting company (full company name and address)
4.  consecutive page numbering (e.g. "page 1 of 1", "page 1 of 10", "page 2 of 10" etc.)
5.  Minimum information per medical device:

• Reference or item number
• Name
• Class
• Basic UDI-DI (for MDR and IVDR products)
• GMDN code (or code of another recognized nomenclature)

Fees

The issuance 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.