• SFDA Guidance: e-IFU Requirements for Medical Devices

    Recently, the SFDA (Saudi Food and Drug Authority) has issued a guidance to clarify the e-IFU (electronic Information for Use) requirements for medical devices in Saudi Arabia. This guidance is issued in reference to the Essential Principles specified in, “Guidance on Requirements for Medical Device Listing and Marketing Authorization (MDS-G5).” It is applicable for medical devices (including IVD medical devices) supplied to the KSA (Kingdom of Saudi Arabia) market, with IFU in electronic form and is intended for professional users.