This episode unpacks a critical update from the Saudi Food and Drug Authority (SFDA) that is reshaping the landscape for digital health and Software as a Medical Device (SaMD) in the Kingdom. As Saudi Arabia tightens its requirements, we explore the new, unwritten rules around cybersecurity and data integrity that are becoming a major hurdle for market access.

We dive into the practical implications of these changes. This is not just about new paperwork; it's about a fundamental shift in how the SFDA evaluates the safety and security of digital medical technologies, moving beyond clinical efficacy to demand robust proof of digital resilience.

**Key Questions Answered in This Episode:**

* What is the single biggest change in the SFDA’s approach to Software as a Medical Device?

* Why are standard cybersecurity protocols no longer enough for the Saudi market?

* How can you prove your device complies with local data privacy laws?

* What documentation is now essential for your submission to avoid rejection?

* Is your post-market surveillance plan ready for the new cybersecurity reality?

* How does this shift signal Saudi Arabia's ambition in the global MedTech scene?

Pure Global offers end-to-end regulatory consulting solutions for MedTech and IVD companies, combining local expertise with advanced AI to streamline global market access. If you're struggling to navigate the evolving regulations in markets like Saudi Arabia, contact us at [email protected] or visit https://pureglobal.com/.