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From Code to Compliance: Pure Global's Expert Guide on Navigating the SaMD Medical Device Classification System in Saudi Arabia
As Saudi Arabia's healthcare market rapidly digitalizes under Vision 2030, understanding the regulatory landscape for Software as a Medical Device (SaMD) is crucial for innovators. This episode provides a deep dive into the Saudi Food and Drug Authority (SFDA) and its risk-based classification system that governs SaMD market access.
We break down the four distinct risk classes—from low-risk data storage apps to high-risk life-support algorithms. Discover why the 'intended use' of your software, not its technical sophistication, is the single most important factor in its classification and learn how this principle is applied in practice with real-world examples that impact go-to-market strategy.
For example, an AI tool designed to predict sepsis risk in ICU patients seems like a data analyzer. However, if it's intended to guide immediate, critical treatment decisions, the SFDA may elevate its classification from moderate to high risk. This shift requires more extensive clinical data and stricter quality audits, potentially delaying market entry and increasing costs significantly.
In this episode, you will learn:
- What is the primary factor the Saudi FDA uses to classify SaMD?
- How does the SFDA's risk classification system align with global standards like the IMDRF?
- What is a real-world example of a low-risk Class A SaMD versus a high-risk Class D SaMD?
- Why might an AI diagnostic tool be classified as high-risk (Class C), and what does that mean for your submission?
- How can a misunderstanding of your SaMD's "intended use" derail your market access strategy in Saudi Arabia?
- What are the key differences in regulatory requirements between a Class B and Class C SaMD?
- Which regulatory body is responsible for MedTech oversight in Saudi Arabia?
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 https://pureglobal.com/ to accelerate your entry into the MENA market.
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By Ran ChenAs Saudi Arabia's healthcare market rapidly digitalizes under Vision 2030, understanding the regulatory landscape for Software as a Medical Device (SaMD) is crucial for innovators. This episode provides a deep dive into the Saudi Food and Drug Authority (SFDA) and its risk-based classification system that governs SaMD market access.
We break down the four distinct risk classes—from low-risk data storage apps to high-risk life-support algorithms. Discover why the 'intended use' of your software, not its technical sophistication, is the single most important factor in its classification and learn how this principle is applied in practice with real-world examples that impact go-to-market strategy.
For example, an AI tool designed to predict sepsis risk in ICU patients seems like a data analyzer. However, if it's intended to guide immediate, critical treatment decisions, the SFDA may elevate its classification from moderate to high risk. This shift requires more extensive clinical data and stricter quality audits, potentially delaying market entry and increasing costs significantly.
In this episode, you will learn:
- What is the primary factor the Saudi FDA uses to classify SaMD?
- How does the SFDA's risk classification system align with global standards like the IMDRF?
- What is a real-world example of a low-risk Class A SaMD versus a high-risk Class D SaMD?
- Why might an AI diagnostic tool be classified as high-risk (Class C), and what does that mean for your submission?
- How can a misunderstanding of your SaMD's "intended use" derail your market access strategy in Saudi Arabia?
- What are the key differences in regulatory requirements between a Class B and Class C SaMD?
- Which regulatory body is responsible for MedTech oversight in Saudi Arabia?
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 https://pureglobal.com/ to accelerate your entry into the MENA market.