A Free Sale Certificate ("FSC") is a certificate issued by the national regulatory authority of the exporting country based on national legislation stating that the product is freely available in the country but without any confirmation that the product has been tested for safety and effectiveness and is licensed for use in the country. The "Export Certificate" or "International Government Certificate" is another name for the Free Sale Certificate. It provides confirmation from a foreign entity that the products listed in the certificate are freely sold and manufactured in the country.
The European Free Sale Certificate (FSC) is proof that medical devices can be legitimately sold or distributed freely and without restriction with the authorization of the country's regulatory authorities. Medical devices that have been duly notified (if needed) and are CE marked are permitted to circulate and be sold across the European Union, according to the European Medical Device Regulation MDR 2017/745 and the In-Vitro Diagnostic Regulation IVDR 2017/746.
An FSC for a CE-marked device can only be issued by a European Authority (Ministry of Health in case of medical devices). If the manufacturer of the CE marked devices are based outside of the European Union, only his appointed European Authorized Representative (EC REP) may submit a request on his behalf.
The following documents are necessary for the issuing of FSC by a European Authority:
- Details on EU Registration
- Certificate of CE
- Declaration of Conformity of the EU, officially signed, dated, and stamped
- Letter of Appointment as EU Representative
- ISO certificate (ISO 9001 and/or ISO 13485 certificates)
However, it is critical to note that before any documentation is produced, the appropriate classification of a device must be validated, as it is the foundation of all things under European legislation - in order to classify devices or simply confirm their classification, the following is required:
- A copy of the product description
- Claimed intent of use.
- Short description of the mode of operation.
- Any supporting evidence of their CE – EC Declaration of conformity, CE certificate, or other compliance certifications
Non-European Authorities may request the Free Sales Certificate to be legalized by three entities in the issuing country:
- The Chamber of Commerce
- The Ministry of Foreign Affairs
- The Relevant Embassy
The process to attain a Free Sale Certificate –
- Create a Technical File
- Apply for NB CE Certification or create a DOC for Class I devices.
- Appoint a European Authorized Representative
- EU Registration of Medical Device
- Apply FSC with medical device authority wherein EAR is located.
The time taken to achieve an FSC after EU Registration of a particular device is 8-12 working days.