Free sale certificate (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 Italian Competent Authority.
The free sale certificate is required by some extra-EU countries 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 manufacturers or by authorized representatives located in Italy.
Please note that FSCs are issued by the Italian 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.
CE marking
Free sale certificate (FSC)
CE conformity
