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 major milestone for homegrown healthcare innovation, 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).
The licence formally authorises the research centre to conduct manufacturing, distribution, and wholesale operations for medical devices for which it holds a registration certificate. This development effectively paves the way for UCT-developed medical technologies to move directly from research laboratories into clinical use across South Africa.
While UCT MedTech and BMERC have spent over a decade building one of the most productive academic medical device pipelines on the continent—boasting 23 patent families, five spinout companies, and more than 100,000 devices distributed globally—every promising design previously hit a regulatory wall. Without a certified manufacturing pathway under their own roof, these locally designed devices could not legally or ethically be deployed in local clinical care.
