Free Sales Certificates (FSC)

Certain countries do not recognize the European CE conformity marking for medical devices and require an export certificate (Free Sale Certificates, FSC) for import, approval and distribution in their country, which must be issued by the competent authority at the registered office of the exporting company. FSCs confirm the formal conformity of the respective medical devices with the legal requirements in Liechtenstein and thus their basic marketability at the time of issue.

The Office of Public Health issues corresponding FSCs for the export of medical devices to third countries to manufacturers and authorized representatives domiciled in Liechtenstein upon presentation of appropriate 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 submitting the following documents (by e-mail to: medical.devices@llv.li):

• Order form for export certificate
• Declarations of conformity from the legal manufacturer
• EC certificates of conformity, incl. any annexes
• Product list

Product list requirements

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

1. Information in English
2. PDF format, formatting: A4, page margins at least 2 cm (top, bottom, left, right)
3. with letterhead of the applicant 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 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 processed by the Office of Public Health within 30 days of receipt of the order and electronic submission of the complete documentation.

Fees

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