This communication is intended to provide an update to industry stakeholders concerning Mpox (formerly monkeypox) diagnostic tests in South Africa....
This document is intended to provide contact details for communicating reportable adverse events, as per Guideline SAHPGL-MD-03, as well as contact details for any Recalls and Market actions for medical devices (including IVDs). Reportable adverse events reports must be emailed to mdvigilance@sahpra.org.za and copy (cc) Puseletso.Mogano@sahpra.org.za...
SAHPRA intends to conduct a voluntary feasibility study for medical device registration to validate the proposed process for registration of medical devices. The medical device registration feasibility study is only for medical devices intended for human use and aims to provide an approach to benefit stakeholders,...
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....
This document is intended to provide clarity on guidelines and applications for the licensing of medical device establishments. It reflects the current situation and will be regularly updated with changes in legislation and experience gained. It is important that applicants adhere to the administrative requirements to...
This document has been archived....
This document has been archived....
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...
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...