Egypt Turns Attention to Device Safety With New Vigilance Guidelines, Office

The Egyptian government has established a Medical Device Safety Department (MDSD) within the Egyptian Drug Authority to manage the collection and review of vigilance information on devices marketed in the North African nation. The new system, which is compatible with Global Harmonization Task Force and European Commission data collection procedures, is described in a 53-page guideline posted to the agency’s website. It applies to both devices and in vitro diagnostic products and spells out responsibilities for devicemakers, users and the MDSD. Manufacturers or their authorized representative should have a “suitable vigilance system” in place to proactively track complaint and incident trends, and notify the MDSD when incidents occur.
International Medical Device Regulatory Monitor