This is the second edition of the South African Health Products Regulatory Authority’s (SAHPRA’s) ReguLetter that will provide a quarterly overview of regulatory decisions relating to safety alerts, recalls and rapid alerts. This edition will provide information for the period July to September 2025....
The South African Health Products Regulatory Authority (SAHPRA) would like to invite you to a Medical Dictionary for Regulatory Activities (MedDRA) training. MedDRA is an international standardised medical terminology developed to facilitate the sharing of regulatory information for medical products used by humans. This communication...
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...
The checklist must be used by the applicant for all new product submissions for human medicines only from 01 October 2025. This template shall be used on receipt of a new human medicine application for registration to verify that all the required information for evaluation has...
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 document outlines the approach that the South African Health Products Regulatory Authority (SAHPRA) has undertaken to implement the process of the renewal of the certificate of registration for medicinal products, ensuring a consistent approach to benefit all stakeholders, thereby guaranteeing that quality, efficacious, and...
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....