Free sale certificate (FSC)

Certificato libera vendita (CLV/FSC)

FREE SALE CERTIFICATE

Coronati Consulting is able to offer assistance in obtaining the Free Sale Certificate including preparation of the documentation and request to the Competent Authority.

The free sale certificate is required by some States to ensure that the goods imported into their country have free movement in Italy and therefore comply with the requirements of national legislation.

The free sale certificate of medical devices can be requested by the manufacturer or by the authorized representative, the distributor or the importer.

Please note that FSCs are issued by the Ministry of Health in Italian or English, based on the request from the company. If the company requests it, the address of the production site can be specified on the Free Sale Certificate.

FREE SALE CERTIFICATE (FSC) OF MEDICAL DEVICES FOR EXTRA EU COUNTRIES 

The CE marking certificate (commonly referred to as FSC) is a declaration that is sometimes required for the export of medical devices and in vitro diagnostic medical devices to EXTRA EU countries. The Certificate of Free Sale is required by some States to make sure that the devices imported into their country have free movement in Italy and therefore comply with the provisions of national legislation.

Quality system

CE marking

Free sale certificate (FSC)

CE conformity

Registration and repertory  (RDM)