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SFDA’s Guidance On Review And Approval Of Artificial Intelligence (AI) And Big Data Based Medical Devices

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  • SFDA’s Guidance On Review And Approval Of Artificial Intelligence (AI) And Big Data Based Medical Devices

SFDA has recently published Guidance On Review And Approval Of Artificial Intelligence (AI) And Big Data Based Medical Devices; Click here to read the official document.

Published on: 27th April, 2021

Highlights from this Document

This guidance applies to the standalone software type of medical devices, to which machinelearning-based AI technology is applied, that diagnose, manage or predict diseases by analyzing medical big data. It is also applicable to AI software that is configured with hardware.
For example, clinical decision supporting (CDS) software or computer-aided detection/diagnosis (CAD) software belong to this category

The purpose of this guidance is to clarify the requirements for obtaining Medical Devices Marketing Authorization (MDMA) for Artificial Intelligence (AI)-based medical devices, in order to place them on the market within the KSA.

Big data and artificial intelligence (AI)-based medical devices can diagnose or predict diseases or provide customized treatment to a patient by learning medical big data and recognizing certain patterns based on machine learning.

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