28 Feb Guideline on Questions and Answers Licensing of Medical Device Establishments
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21 Nov General Information Medical Devices And IVDs
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Download Version 1 (8.01)Date updated
...21 Nov Guideline For Access To And Control Of Medical Devices And IVDs
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...30 Aug Withdrawal of Section 21 Authorisation for use of unregistered rapidly developed non-invasive ventilators
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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
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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
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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
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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
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2022 Mar...