This episode of MENA MedTech Insights dives into a critical regulatory challenge in Saudi Arabia: how the Saudi Food and Drug Authority (SFDA) differentiates between a low-risk medical device and a general wellness or non-medical product. We explore how a product's intended use and marketing claims are the ultimate deciding factors, directly impacting your path to market access. Understanding this distinction is not just a box-ticking exercise; it's a strategic decision that can save you months of delays and significant costs. We unpack the SFDA's mindset and provide clear guidance on how to position your product for a successful and efficient launch in the Kingdom. A real-world case: Imagine launching an innovative skincare device that uses light therapy. You market it as a tool for "rejuvenating skin." To the SFDA, this might be a cosmetic tool. But if your marketing team switches the claim to "treating acne," you've just crossed into the world of regulated medical devices. This single word change triggers the need for a full technical dossier, a local authorized representative, and the lengthy MDMA approval process. We discuss how to navigate these borderline cases where your marketing can make or break your regulatory strategy. Key questions answered in this episode: - What is the single most important factor the SFDA uses to classify a borderline product? - How can a simple marketing claim turn your wellness app into a regulated medical device in Saudi Arabia? - Why might a product be considered a medical device in the EU but not in the KSA, or vice-versa? - What are the real-world consequences of misclassifying your product with the SFDA? - How does the SFDA view wearables that track health metrics versus those that claim to detect medical conditions? - At what point should you proactively seek a formal classification decision from the SFDA? - What documentation is needed for a low-risk device that a non-medical product can completely avoid? Don't let regulatory uncertainty dictate your market success. At Pure Global, we provide end-to-end regulatory consulting for MedTech and IVD companies, combining local Saudi expertise with advanced AI tools to streamline your market access. From developing a robust regulatory strategy to compiling and submitting your technical dossier, we act as your local partner on the ground. Contact us to clarify your device classification and accelerate your entry into the MENA market. Email us at [email protected] or visit https://pureglobal.com/.