South Africa does not currently register medical devices. So what does it mean when the regulator announces that a new COVID-19 test or ventilator has been authorised? Catherine Tomlinson unpacks what is required to market a medical device in South Africa.
With abortion services now available through telemedicine and the increasing practice of self-managed abortion, Marion Stevens asks if abortion law still has any relevance given these practices.
Over the last decade the treatment of hepatitis C, a virus that can infect and damage the liver, has been revolutionised by a new class of medicines called direct acting antivirals. Catherine Tomlinson investigates the regulatory obstacles that are limiting access to these breakthrough medicines in South Africa.
The board of the South African Health Products Regulatory Authority (SAHPRA) has held its first meeting, thus officially bringing SAHPRA into existence. This means that South Africa’s old regulatory authority, the Medicines Control Council, no longer exists.