Medical Device & IVD
Certificate of Free Sale (CFS)
550+ Medical Device & IVD Manufacturers Trust MedEnvoy as Their Importer or Representative
Medical device regulators in Brazil, Japan, China, India, Saudi Arabia and other countries often require a Certificate of Free Sale (CFS), also commonly known as an export certificate. In the EU and Switzerland, this certificate demonstrates that that the devices can be legally sold there and meet all local regulations. As your European Authorized Representative (EC REP) or Swiss Authorized Representative (CH REP), we can help you determine which countries require a CFS, see which devices can be grouped onto one certificate, and order the export certificates from the Dutch Competent Authority or Swissmedic on your behalf.
Medical Devices and IVDs That Require an Export Certificate in the European Union or Switzerland
A Certificate of Free Sale is required for all medical devices and IVDs, including procedure packs and even Software as a Medical Device (SaMD).
You’ll need a separate certificate for each country you export to outside the EU or Switzerland
An export certificate is required for each medical device group but does not apply to components
It generally takes about a month to obtain an export certificate
CFS are valid for 3 years (5 years for Thailand)