SAHPRA recently announced that the Section 36(1) Exemption requiring medical device companies to be ISO13485 Certified by the time that they renewed their Medical Device Establishment Licenses for a further three years.
SAHPRA recently announced that the Section 36(1) Exemption requiring medical device companies to be ISO13485 Certified by the time that they renewed their Medical Device Establishment Licenses for a further three years.
Designating the Medical Device Sector has been a “priority” for some time but more pressure has to be placed on the Department of Trade and Industry to move ahead and assist the sector in reaching its full potential
South Africa needs to test 12 times more people per day for the new coronavirus than it currently does. Our testing plan can only do this if we use a wider range of tests – including controversial ones.
The coronavirus (Covid-19) outbreak has revealed both the strengths and weaknesses of South Africa’s healthcare system. On the other hand, the Covid-19 pandemic presents a greater opportunity to develop South Africa’s health sector value chain.
The president hopes the HSACF will guard against the corruption that Health Minister Zweli Mkhize admitted would be a ‘threat’ to his new universal healthcare bill.
The long-awaited Health Market Inquiry has finally been published. The report represents the single largest and most comprehensive report into the private healthcare industry in South Africa.
How will the Medical Device Industry in South Africa be impacted by the National Health Insurance Bill?
Some of the world’s best designers, engineers and clinicians, South Africa has the potential to make its mark as a central health innovation hub in the global south.
The National Health Insurance Bill has in many sectors and in Government spin equating NHI with Universal Healthcare. This article, originally published in Health-e News highlights the plight of rural and poor people, who theoretically stand to gain the most from NHI.
Regulatory challenges with rapid rise...
The article from MedicalBrief highlights the rapid integration of artificial intelligence (AI) into medical devices. This