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.
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.
The MCC will soon be replaced by the South African Health Products Authority (SAHPRA). Spotlight asked MCC registrar Dr Joey Gouws and MCC chairperson Professor Helen Rees about changes at South Africa’s medicines regulator.