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01 Oct Guideline on Traceability of Health Products

Posted at 14:31h in

The purpose of the document is to guide the implementation of global standards for product identification, data capture, and data sharing. It represents the South African Health Products Regulatory Authority’s (SAHPRA)’s current thinking on the safety, quality and efficacy of medicines. The implementation of unique...

29 Sep Communication to Industry – SAHPRA Online Directory Update

Posted at 16:13h in

The SAHPRA OTC Online Directory has been operational for some time. As outlined in the OTC Toolkit, it is mandatory to include the required lock-ins on all Schedule 0–2 promotional and advertising materials....

29 Sep Communication to Industry – Pilot: Clinical Trial Applications Electronic System

Posted at 15:48h in

This communication is issued in view that SAHPRA has embarked on a process to digitalise its business processes and need to pilot the electronic process. The pilot is planned for new medicinal clinical applications for the month of October 2025, with the official launch of...

09 Sep Amendment of the training dates for the MedDRA Training

Posted at 14:08h in

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...

09 Sep Post Market Surveillance and Post-market Clinical Follow-up Studies

Posted at 10:34h in

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...

09 Sep Guidelines on Clinical Evaluation of Medical Devices

Posted at 10:33h in

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...

09 Sep Guideline on Clinical Investigation of Medical Devices

Posted at 10:07h in

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...

29 Aug Reprocessing of Single Use Medical Devices

Posted at 11:28h in

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....

26 Aug Medicines Certificate of Registration Renewal Implementation Framework

Posted at 14:24h in

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...

19 Aug Regulatory Requirements of Artificial Intelligence and Machine Learning (AI/ML) Enabled Medical Devices

Posted at 19:57h in

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....

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