31 Jan Regulations Relating to Medical Devices and In-Vitro Diagnostic Medical Devices (IVDs)
Posted at 11:26h
in
Archive
02 Oct SAHPRA position on EU regulatory transition for medical devices from MDD/AIMDD/IVDD to MDR 2017/745 /IVDR 2017/746
Posted at 09:49h
in
This communication to industry refers to the Medical Device Unit and Radiation Control Unit publishing SAHPRA’s position on EU regulatory transition for medical devices from MDD/AIMDD/IVDD to MDR 2017/745 /IVDR 2017/746....
21 Nov General Information Medical Devices And IVDs
Posted at 12:20h
in
This document has been archived....
21 Nov Guideline For Access To And Control Of Medical Devices And IVDs
Posted at 12:08h
in
This document has been archived....
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...
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...
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...
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....