Medical Devices – Compliance Alert
According to a Royal Decree that was published in December 2017, all distributors of medical devices that cover the Belgian market and all Belgian exporters of medical devices must register on the new Web Portal of the Belgian Federal Agency for Medicines and Health Products (FAMHP).
In addition, distributors of medical devices and hospitals that use medical devices in Belgium must comply with new materiovigilance rules (reporting duties).
Law Square is ready to assist you quickly and efficiently. Companies have until May 2018 to register.