Archive

The primary goal of self-testing is to aid with the early detection of SARS-CoV-2, reduce transmission, and enable people to follow public health measures to control COVID-19 and keep societies open during the pandemic. Ag-RDT self-tests play an important role in enabling decentralised testing and...

To achieve certification to the ISO13485 standard for medical devices, the certification process requires each medical device establishment to implement a formal QMS which must be inspected and certified by an independent conformity assessment body (CAB) which has in turn been accredited by The South...

As per SAHPRA continuous interaction with stakeholders, Medical Device Unit would like to advise all stakeholders about the intention to host a workshop during the Month of April 2022 with regards to the following topic....