In accordance with the royal decree issued on 25/01/1428H (13 February 2007) which assigned the responsibility of regulating medical-devices, in vitro diagnostic devices, prescription eye glasses, contact lenses and their solutions to the Saudi Food and Drug Authority (SFDA). And the council of ministers decree No. 181 on 03/06/1428H (18 June 2007) which gives the SFDA full authority to issue guidance that include rules and procedures of registering medical-devices establishments and their products. The Saudi Food & Drug Administration (SFDA) is responsible for protecting patients and the public from deficient medical products. To do so it maintains an up-to-date database of medical-devices recalls and problem reports. This database includes products manufactured in or imported into the Kingdom of Saudi Arabia (KSA). SFDA also works closely with hospitals and healthcare providers to help them take appropriated corrective action.

The Problem Reporting Center (PRC) welcomes reports of suspected medical-devices problems and confirmed product recalls from healthcare practitioners and devices suppliers within the Kingdom of Saudi Arabia. SFDA personnel investigate all submissions and, when possible, provide technical and clinical guidance to allow all affected parties (not merely the original reporter) to avoid or resolve problems. PRC’s overarching goal is improving patient and caregiver safety through the distribution of accurate, actionable information. Since the system’s success is best ensured by active and ongoing participation, SFDA strongly encourages all members of the medical community to take part.