This communication is intended to provide an update to industry stakeholders concerning Mpox (formerly monkeypox) diagnostic tests in South Africa. The regulatory requirements for Mpox diagnostics can be found in Communication to Industry: Issue No.: MD01-2024/25 v1...
The international standard ISO 13485 (ISO 13485:2016 Medical Devices - Quality Management Systems – Requirements for regulatory purposes) for a quality management system (QMS) is recognised globally to address minimum regulatory requirements for medical devices and in vitro diagnostics (IVDs). The standard outlines the requirements...
This document is intended to assist the holder of a medical device establishment licence (referred to as the “licensee)” and the holder of a certificate of Registration (HCR) in the reporting of an adverse event associated with the use of a medical device (including an...
This guideline provides the information to be supplied to SAHPRA when completing the form to report an adverse event for a medical device (including an IVD), it outlines the format and data requirements for reporting of an adverse event, using the Medical Device Adverse Event...
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....
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