The South African Health Products Regulatory Authority (SAHPRA) has granted a medical device manufacturing licence to the University of Cape Town’s (UCT) Biomedical Engineering Research Centre (BMERC), signalling a giant stride for local healthcare development, reports IOL.
Professor Sudesh Sivarasu, director of BMERC, said this 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.
“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.”
South Africa imports most of its medical devices, leaving the local healthcare system exposed to supply chain shocks.
“It also compels our clinicians to work with technologies that were designed, almost without exception, for high-income settings,” he said, adding that the newly acquired licence represents a critical solution to these challenges.
Over the past decade, UCT MedTech and BMERC have built one of Africa’s most productive academic medical device pipelines, achieving milestones like 23 patent families, the establishment of five spinout companies, and the distribution of more than 100 000 devices globally.
However, despite these accomplishments, the absence of a certified local manufacturing route had hindered the potential for these devices to be deployed ethically and legally within the South African healthcare system.
“In the medical device sector, quality is synonymous with patient safety,” observed Sivarasu. “Without being able to show that our devices were manufactured under a rigorous, audited quality management system, we could not ethically or legally deploy them with patients.”
There are major benefits of the certification, including that quality management systems will now be independently assessed and certified against international standards, while apart from in-house manufacturing slashing reliance on costly imports, the licenced facility will expedite the capacity to train the next generation of biomedical engineers in a real-world, regulatory-compliant environment.
Sivarasu said the achievement was the result of a collective effort from researchers, students and staff at UCT, alongside partnerships with the national Department of Science, Technology, and Innovation (DSTI), the National Research Foundation (NRF), and clinical collaborators across the Western Cape Department of Health.
The immediate focus for BMERC will now shift to converting a pipeline of late-stage prototypes into clinically validated products produced on-site.
“Our goal is that, within the next 18 to 24 months, devices manufactured at UCT’s medical school are in routine clinical use in South African public hospitals,” he said.
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