Saudi Arabia just released new draft regulations for AI-based medical devices, creating both a clear pathway and significant new challenges for MedTech innovators. This move by the Saudi Food and Drug Authority (SFDA) signals a major step towards maturing the region's regulatory environment, but it comes with stringent new demands.

This episode of MENA MedTech Insights dives deep into the specifics of this new guidance. We unpack the critical requirements around local population data for clinical validation, algorithm transparency, and the tough new cybersecurity standards that will impact any company looking to launch AI-driven healthcare solutions in the Kingdom.

**What you'll learn:**

* What are the top three surprising clauses in the SFDA's new AI guidance?

* Why might your existing FDA or CE-approved AI device not qualify for the Saudi market?

* Is local clinical data now a non-negotiable for AI device approval in the Kingdom?

* What level of "explainability" does the SFDA demand from your AI algorithm?

* How does the new risk classification system impact your product's path to market?

* What specific cybersecurity vulnerabilities are the SFDA most concerned about?

* How can you leverage this regulatory shift to gain a competitive edge in the MENA region?

Pure Global offers end-to-end regulatory consulting solutions for Medical Technology (MedTech) and In-Vitro Diagnostic (IVD) companies, combining local expertise with advanced AI and data tools to streamline global market access. Contact Pure Global at [email protected] or visit us at https://pureglobal.com.