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In case the manufacture sells medical devices directly to customers without an Authorized Representative (AR), who is responsible for informing the affected customers and providing the corrective action plan and closure? FAQ

If software update for a medical device imported to KSA is released, but this update is only for improvement not due to a problem or malfunction in the device. Is it mandatory to inform SFDA about this action and provide all the requirements for its closure? FAQ

(SG-2008-257-H) Black dirt in water of Hydrox Medical Report

Drug Master File : Guidance for Submission Regulations

Guidance for Priority Review of Product Registration Regulations

(SG-2008-261-H) Medumat Standard 2 Cannot be switched-on in battery mode Medical Report

(SG-2008-260-H) COVID-19 IG/IgM Test Medical Report

(WU2036) NCMDR Weekly Update Medical Report

Awareness Campaigns of Diseases and Health Education Regulations Regulations

Requirements for Advertisement Approval and Launching Awareness and Charity Campaigns for Medical devices (MDS-REQ8) Regulations