JOHANNESBURG, SOUTH AFRICA | Artificial intelligence diagnostic tools in South Africa are moving out of pilot projects and into routine clinical workflows, a shift that brings them under formal device regulation, the technology publication Lifestyle & Tech reported on Monday.
The South African Health Products Regulatory Authority has confirmed that AI and machine learning enabled medical devices must clear the country’s medical device framework before they can be placed on the market. That requirement moves procurement discussions away from published accuracy scores and toward evidence of clinical relevance and regulatory readiness.
Edward Kunonga, chair of the Healthcare Excellence Indaba, said validation cannot be imported wholesale. “Local validation on South African and African patient populations is essential, as is testing the technology within real healthcare systems,” he said.
Jackie Stewart, chief executive of the Council for Health Service Accreditation of Southern Africa, said the tools should stay in a supporting role. “Technology or AI should serve as a healthcare practitioner’s assistant, not a decision-maker,” she said.
South Africa’s connected healthcare market was valued at about $47 million in 2025 and is projected to reach $77.4 million by 2033, according to figures cited in the report.
Why it matters: African health systems buying AI tools now need local validation evidence, not vendor accuracy claims from other populations.
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