Saudi Arabia SFDA Risk Communication Guidance: What MDS-G-029 Means for Manufacturers

Medical Device Global Market Access · Jul 19, 2026 · 5m

The Saudi Food and Drug Authority (SFDA) published a new guidance, MDS-G-029, on July 9, 2026, establishing formal requirements for medical device risk communication. This episode breaks down the key principles of the guidance, including the responsibilities of manufacturers and their Authorized Representatives, the expected content and channels for communication, and the impact on post-market surveillance and vigilance systems for devices sold in Saudi Arabia. Key Questions: - What is the new SFDA guidance MDS-G-029 about? - Who does this new risk communication requirement apply to? - What…