This document intends to provide clarity on SAHPRA’s Core Business Escalation procedure, to enable effective and efficient communication between SAHPRA and its stakeholders....
This guideline is intended to provide recommendations to Manufacturers, Importers, Exporters, Distributors, and Holders of certificates of Registration (HCR) of medical devices. It represents the South African Health Products Regulatory Authority’s (SAHPRA) current thinking on the safety, quality, and performance of medical devices. It is...
This guideline is intended to clarify the requirements of conducting a clinical evaluation of a medical device in South Africa. It represents the South African Health Products Regulatory Authority’s (SAHPRA)’s current thinking on the safety, quality and performance of medical devices under clinical investigation. It...
This guideline is intended to clarify the requirements of conducting a clinical investigation in a medical device in South Africa. It represents the South African Health Products Regulatory Authority’s (SAHPRA)’s current thinking on the safety, quality and performance of medical devices under clinical investigation. It...
This document is intended to communicate the position of the South African Health Products Regulatory Authority (SAHPRA) on reprocessing of single use medical devices to stakeholders....
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...