It is well known that for Medical and In Vitro Diagnostic Devices, the best tool easing the access to non-European markets is the Free Sales Certificate, which allows the manufacturer to prove the compliance of his devices with the EU laws and safety standards. These EU standards are then fully accepted and welcomed as the best possible ones also outside the European Union, typically as an official proof of compliance or generally to clear the Customs.
Yet, the Competent Authorities of some specific countries went even further, and have set out an EU Free Sales Certificate (EU FSC) as a mandatory requirement to be shown during national registration process of the devices.
This is the case for example in Serbia and Bosnia, where an EU FSC is always required for: general medical device(s), active implantable medical device(s) and in vitro diagnostic medical device(s), as well as a mixture of the above devices.
Davide Turchi
DPM – Regulatory Affairs Department
17/07/2020
Obelis is proud to inform you that we provide assistance with Free Sales Certificate applications since more than 30 years now.
If you would like to enter the Serbian or Bosnian market, or in general the EU market or any other market worldwide, please do not hesitate to contact us, and our Free Sales Certificates Specialists will provide you with the best possible feedback.