In this episode of MENA MedTech Insights, we delve into a critical challenge for innovators: how to manage updates for AI-powered medical software that is already registered with the Saudi Food and Drug Authority (SFDA). The iterative nature of AI development clashes with rigid regulatory frameworks, creating a significant hurdle for manufacturers. We break down the SFDA's risk-based approach, exploring the crucial difference between a 'substantial' and 'non-substantial' change. Understanding this distinction is key to ensuring continuous compliance and avoiding costly delays or market access issues in Saudi Arabia. We provide concrete examples and outline the necessary steps for submitting a successful variation application. A real-world example illustrates the pain point. A company with an approved AI tool that assists in diagnosing diabetic retinopathy releases a software patch intended to improve image processing speed. However, this patch inadvertently alters the sensitivity of their diagnostic algorithm, a change they classified as minor. This episode explores how the SFDA would view this 'minor' update and the potential regulatory consequences of such a misstep. Key takeaways from this episode: - What is the single most important question the SFDA expects you to answer before any software update? - How can a simple change to your software's user interface be considered a "substantial modification"? - When can you update your AI medical software without notifying the SFDA at all? - What specific documentation is non-negotiable for an update involving a change to the core algorithm? - Why is your internal Change Control Procedure the first line of defense against SFDA non-compliance? - How does the SFDA's approach to AI software updates compare to the FDA or European MDR? - What is the biggest mistake companies make when classifying a software change? At Pure Global, we specialize in demystifying complex regulatory pathways. From developing a compliant change control process to managing submissions with the SFDA, our blend of local MENA expertise and advanced AI tools ensures your innovations stay on the market. Let us handle the regulatory hurdles so you can focus on development. Contact our experts today at [email protected] or visit https://pureglobal.com/ to learn more.