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...
Reckitt Benckiser Pharmaceuticals (Pty) Ltd in collaboration with the South African Health Products Regulatory Authority (SAHPRA), wish to draw your attention to the risk of posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome associated with the use of pseudoephedrine-containing medicines....
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...
In collaboration with the South African Health Products Regulatory Authority (SAHPRA), Johnson and Johnson (Pty) Ltd would like to inform you about the risk of posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS) associated with the use of pseudoephedrine-containing medicines....
This document intends to communicate to all the users of Group III and IV hazardous substances about the processes of sealing and unsealing the equipment. The sealing of dangerous substances is an enforcement action and may occur during announced and/or unannounced inspections or in the...
The South African Health Products Regulatory Authority (SAHPRA) announces urgent webinars scheduled for Monday, 07 April 2025, Wednesday, 09 April 2025 and Friday, 11 April 2025 from 14:00-16:00....
The South African Health Products Regulatory Authority (SAHPRA) Engagement Portal launched on 01 April 2025. We thank applicants for embracing the new system, quickly adapting to it, and promptly bringing to our attention any challenges encountered. This communication seeks to resolve a frequently encountered challenge...
Your attention is drawn to the provisions of the Medicines and Related Substances Act, 101 of 1965, as amended, which provide for the payment of retention fees to the South African Health Products Regulatory Authority (SAHPRA) in respect of medicines registered and medical devices, including...
Applicants are hereby notified that the South African Health Products Regulatory Authority (SAHPRA) Engagement Portal is set to launch at midday on 01 April 2025....