Saudi Arabia SFDA Medical Device Advertising Rules: MDS-REQ 8 Compliance for Manufacturers

The Saudi Food and Drug Authority (SFDA) has implemented new mandatory requirements for medical device advertising, effective July 20, 2026. This episode breaks down the key provisions of the new guidance, MDS-REQ 8, which mandates pre-approval from the SFDA for all advertising, awareness, and charitable campaigns. We explore the broad scope of materials covered—from social media to brochures—the official submission process through the GHAD electronic system, and the critical responsibilities of manufacturers, authorized representatives, and distributors. Tune in for practical steps your regulatory and marketing teams must take to ensure compliance and maintain market access in Saudi Arabia. Key Questions: - What is the new SFDA requirement MDS-REQ 8 for medical device advertising? - When did these new advertising rules become effective in Saudi Arabia? - Which types of promotional materials require SFDA approval? - Who is responsible for obtaining the advertising license for medical devices? - What is the process for submitting advertising materials to the SFDA via the GHAD system? - How does this regulation impact social media and digital marketing campaigns? - What are the key compliance conditions for advertising content to avoid rejection? - What immediate steps should regulatory and marketing teams take to align with MDS-REQ 8? - How can manufacturers avoid penalties for non-compliant advertising in the Kingdom? Sources: - https://www.sfda.gov.sa/en/laws-regulations?type=338 How Pure Global can help: Pure Global provides end-to-end regulatory support for MedTech and IVD companies seeking to navigate complex markets like Saudi Arabia. Our local experts can act as your official Saudi Authorized Representative, manage your advertising submissions under MDS-REQ 8, and develop a comprehensive regulatory strategy to ensure compliance and speed to market. We combine in-country expertise with advanced AI tools to streamline technical dossier preparation and submission management. To learn how we can help you access over 30 global markets efficiently, contact us at [email protected] or visit https://pureglobal.com. Explore our free AI regulatory database and tools at https://pureglobal.ai.