1. Clear Distinction Between Medical and Wellness Products

The guidance clearly defines regulatory boundaries between:

• SFDA-regulated medical devices, and

• Non-regulated wellness or lifestyle applications

This helps companies determine early whether their product falls under SFDA oversight, reducing uncertainty and regulatory risk.

2. Risk-Based Regulatory Framework

MDS-G27 introduces a risk-based classification approach for digital health technologies, covering:

• Mobile health (mHealth) apps

• Software as a Medical Device (SaMD)

• AI/ML-enabled clinical tools

Higher-risk products face stricter regulatory controls, while lower-risk solutions benefit from proportionate oversight.

3. Defined Classification Criteria

The guidance sets out clear criteria based on:

• Intended medical purpose

• Interaction with patient health data

• Clinical decision-making impact

This enables developers to accurately assess whether their product requires SFDA registration, listing, or approval.

4. Balanced Compliance & Innovation

SFDA ensures that compliance requirements align with patient safety and product performance, while still encouraging innovation in digital health and AI technologies.

Why MDS-G27 Matters for Digital Health Companies

Saudi Arabia is actively bridging innovation with regulatory clarity. MDS-G27 empowers developers and manufacturers to bring digital health solutions to market with confidence and transparency, avoiding regulatory ambiguity.

Importantly, even software-only products may now fall under regulatory scrutiny if they:

• Interact with health or patient data

• Influence diagnosis, monitoring, or treatment decisions

This represents a major shift for tech-driven healthcare companies previously operating outside traditional medical device regulations.

How RIAR Consulting Can Support You

Navigating SFDA’s evolving digital health regulations requires expert regulatory strategy and early planning. At RIAR Consulting, we help companies:

• Determine product classification under MDS-G27

• Develop compliant digital health regulatory strategies

• Manage SFDA registration and submissions

• Align innovation roadmaps with Saudi regulatory expectations

Final Thoughts

SFDA’s MDS-G27 is more than a guidance—it is a strategic framework shaping the future of digital health regulation in Saudi Arabia. Companies that understand and adapt early will gain a strong competitive advantage in one of the Middle East’s fastest-growing healthcare markets.

Need a quick breakdown of how MDS-G27 impacts your digital health product strategy?
RIAR Consulting is here to guide you—reach out to our regulatory experts today