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Regulatory Requirements of Artificial Intelligence and Machine Learning (AI/ML) Enabled Medical Devices

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19 Aug Regulatory Requirements of Artificial Intelligence and Machine Learning (AI/ML) Enabled Medical Devices

Posted at 19:57h in by

This communication is intended to provide industry stakeholders with the regulatory requirements of Artificial Intelligence and Machine Learning (AI/ML)-enabled medical devices in South Africa.

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Document Number: MD08-2025/2026
Version: 1
Date Updated: 19/08/2025
File Type: pdf
Category: Communication to industry
Unit: Medical Devices