Archive

30 Aug Withdrawal of Section 21 Authorisation for use of unregistered rapidly developed non-invasive ventilators

Posted at 10:01h in

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...

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15 Jul COVID-19 Test Kits Batch Verification

Posted at 12:45h in

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...

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13 Jun Retention Fee Notification – 9 June 2022

Posted at 16:03h in

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...

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06 Jun Update on COVID-19 Diagnostic tests

Posted at 13:17h in

2020 May...

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03 Apr Specification criteria for COVID-19 rapid antigen selftests

Posted at 20:39h in

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....

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01 Apr Conformity of assessment body DoC template

Posted at 14:34h in

2022 Mar...

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01 Apr Conformity assessment body(cab) requirements for recognition by Sahpra checklist

Posted at 14:32h in

2022 Mar...

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01 Apr Usability studies for Covid-19 self-testing kits requirements

Posted at 14:17h in

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...

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01 Apr Conditions for use of COVID-19 antigen self-test kits

Posted at 14:14h in

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...

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01 Apr ISO 13485 Conformity Assessment Body Communication

Posted at 09:48h in

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...

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