FREE SALE CERTIFICATE
Free Sale Certificate (FSC) for Medical Device
Many Ministries of Health and other regulators around the world require foreign manufacturers to provide a Free Sale Certificate showing that their products are approved for sale in Europe. In these markets, your FSC must be presented to authorities as part of your registration process. Certlink Certification Services has obtained FSC documents for many clients seeking medical device registration in Asian, Middle Eastern, and Latin American markets, and can obtain a FSC on your behalf for your medical device.
How to obtain a FSC for your medical device
A FSC is issued by a European Competent Authority upon request by an Authorized Representative on behalf of a medical device manufacturer. The FSC certifies that your medical device may be legally marketed in the European Union. Based in the Italy, Cerlinkas an Authorized Representative can request FSC documents from the Italian Competent authority on behalf of our clients.