Archive

The Medicines and Related Substances Act, 1965 (Act 101 of 1965) as amended, (“the Medicines Act”) makes provision for the payment of retention fees to the Regulatory Authority in respect of medicines, medical devices and IVDs registered and site licences issued. Further to the above, Regulation...

On the 5th of March 2020, Minister of Health Zweli Mkhize confirmed the spread of the virus to South Africa, with the first known patient being a male citizen who tested positive upon his return from Italy. The vast range of self-testing kits as well...

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....