SA regulations drafted for Covid-19 ventilator manufacturers
Cape Town - The South African Health Products Regulatory Authority (Sahpra) has drafted minimum regulatory requirements and technical specifications for Covid-19 ventilator manufacturers.
Chief executive Boitumelo Semete said: “In response to the shortage
of ventilators in the health-care system as a result of the pandemic, Sahpra has provided for an alternate, streamlined, expedited pathway to licensing of unregistered ventilators during
The minimum requirements for the sale of rapidly developed invasive or non-invasive ventilators are that the medical device establishment responsible for the manufacture, import, export or distribution of any ventilator is licensed by Sahpra.
“Other requirements are that the ventilator is specified as outlined in the Medicines and Related Substances Act and authorised in terms of Section 21 of the Medicines Act, for emergency.
“The ventilators must comply with the latest version of the World Health Organization (WHO) Technical specifications for invasive and non-invasive ventilators.”
According to the WHO: “These technical specifications describe the minimum requirements that invasive and non-invasive ventilators must comply with to ensure quality, safety and effectiveness when used for the management of Covid-19.”
The WHO said its data suggested 80% of infections were mild or asymptomatic, 15% severe, requiring oxygen, and 5% critical, requiring ventilation.
This week, the Unique Group, a Cape Town-based engineering company that makes undersea equipment, announced the completion of the
last stage of testing of its Covid-19
pressure ventilator system made specifically for Africa - the Uni-Life 100 system.
Group director for its Africa operations Rodney McKechnie said the firm was ready to start mass production.
In May, aerospace and military technology company Denel said
two projects to design and manufacture ventilators had reached critical stages.