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Guidance on Artificial Intelligence (AI) and Machine Learning (ML) technologies based Medical Devices

https://www.sfda.gov.sa/sites/default/files/2023-01/MDS-G010ML.pdf
Added by:   National contact point
Added on:   09 Jul 2025
Updated by:   OECD analyst
Updated on:   09 Jul 2025
This guidance applies to Artificial Intelligence (AI) and Machine Learning (ML) technologies that diagnose, manage or predict diseases by analyzing medical data.

Name in original language

Guidance on Artificial Intelligence (AI) and Machine Learning (ML) technologies based Medical Devices

Initiative overview

To be determined

Name of responsible organisation (in English)

Saudi Food and Drug Authority (SFDA)

AI Tags

InnovationAI SafetyAI CapabilitiesAI MeasurementAI-enabling EcosystemAI Compute

About the policy initiative

Saudi Arabia
Saudi Arabia

Organisation:

  • Saudi Food and Drug Authority (SFDA)

Category:

  • National – AI policy initiatives, regulations, guidelines, standards and programmes or projects

Initiative type:

  • Principles/guidelines/frameworks for trustworthy AI

Participating organisations:

—

Participating countries:

—

Status:

  • Active

Start Year:

  • 2022

Binding:

  • Non-binding

Other relevant urls:

—

Official PDF: