21 Nov Guideline For Access To And Control Of Medical Devices And IVDs
Posted at 12:08h
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30 Aug Withdrawal of Section 21 Authorisation for use of unregistered rapidly developed non-invasive ventilators
Posted at 10:01h
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In response to the anticipated shortage of medical supplies and equipment in the health care system as a result of the outbreak of the Covid-19 pandemic, the South African Health Products Regulatory Authority (the Authority) published minimum requirements for the manufacture, importation, and distribution of...
15 Jul COVID-19 Test Kits Batch Verification
Posted at 12:45h
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The COVID-19 pandemic is caused by SARS-CoV-2, a novel coronavirus that originated in Wuhan, China in late 2019. The virus has since spread around the world, with novel variants of concern causing new waves of infection. Testing is a critical component of COVID-19 control and...
13 Jun Retention Fee Notification – 9 June 2022
Posted at 16:03h
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Payment of Retention Fees for the Year Ending 31 December 2022 in respect of Medicines Registered up and until 31 December 2021 and/or Various Licences...
03 Apr Specification criteria for COVID-19 rapid antigen selftests
Posted at 20:39h
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The COVID-19 pandemic is caused by SARS-CoV-2, a novel coronavirus that originated in Wuhan, China in late 2019. The virus has since spread around the world, with novel variants of concern causing new waves of infection....
01 Apr Conformity assessment body(cab) requirements for recognition by Sahpra checklist
Posted at 14:32h
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2022 Mar...
01 Apr Usability studies for Covid-19 self-testing kits requirements
Posted at 14:17h
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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...
01 Apr Conditions for use of COVID-19 antigen self-test kits
Posted at 14:14h
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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...