Local Medical Device Production Gains Momentum at UCT

The drive toward local medical device production gained major momentum when the University of Cape Town’s Biomedical Engineering Research Centre obtained a manufacturing licence from the South African Health Products Regulatory Authority.

Breaking Import Dependencies

This authorisation enables the production, distribution, and wholesale of registered medical devices, moving locally designed technologies from research labs into everyday clinical use across South Africa and easing long-standing reliance on imported equipment.

Procedures were aligned with SAHPRA requirements and international quality standards equivalent to ISO 13485, creating an audited framework that supports ethical deployment and reduces external supply risks while advancing local medical device production capacity.

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Boosting Regional Healthcare Access

The licence underpins cost-effective, context-appropriate solutions that cut import costs and improve market access, with prototypes expected to reach public hospitals within 18–24 months and contribute to broader health-system resilience.