This communication is intended to provide industry stakeholders with the regulatory requirements of Artificial Intelligence and Machine Learning (AI/ML)-enabled medical devices in South Africa....
The Medicines and Related Substances Act 101 of 1965, as amended, read together with the Regulations related to Medical Devices and IVDs, provides for the regulatory oversight of Medical Devices, including In Vitro Diagnostics (IVDs) in South Africa. In terms of Section 22C(1)(b) of the...
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 event reports must be emailed to: mdvigilance@sahpra.org.za....
The Medicines and Related Substances Act, 1965 (Act 101 of 1965) as amended, read in conjunction with the General Regulations on Medical Devices, published in Government Gazette Notice 40480, No.1515 of 9 December 2016, provides for the regulatory oversight of veterinary medical devices including In-Vitro...
MPXV molecular test kit/s that have not been listed, registered or authorised for use in a jurisdiction recognised by the South African Health Products Regulatory Authority (SAHPRA) or that have not been pre-qualified by the World Health Organisation (WHO) will be screened against the minimal...
The first human case of Mpox was reported in the Democratic Republic of Congo; the outbreak has since spread to other countries, including South Africa. South Africa is currently experiencing an outbreak of Mpox clade II. Mpox (previously known as Monkeypox) is an infectious disease...
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...
