The University of Cape Town’s (UCT) Biomedical Engineering Research Centre (BMERC) has officially received its medical device manufacturing licence from the South African Health Products Regulatory Authority (SAHPRA).
In a landmark achievement for local healthcare development, the University of Cape Town’s (UCT) Biomedical Engineering Research Centre (BMERC) has officially obtained its medical device manufacturing licence from the South African Health Products Regulatory Authority (SAHPRA). This milestone authorises the centre to manufacture, distribute and wholesale medical devices, facilitating the transition of innovative UCT-developed technologies from research lab benches to clinical applications across South Africa.
Professor Sudesh Sivarasu, director of BMERC, highlighted the importance of this milestone, stating, “In practical terms, it means the devices we design and develop here, for African patients in an African context, can now be produced and brought to market with the full weight of regulatory recognition behind them.”
Professor Sivarasu noted, “South Africa imports the overwhelming majority of its medical devices, which leaves our healthcare system exposed to supply chain shocks and forces our clinicians to work with technologies that were designed, almost without exception, for high-income settings.” The newly acquired licence represents a critical solution to these structural challenges.
