The South African Health Products Regulatory Authority (SAHPRA) notifies all applicants that Type II Variations Pilot submission window has been extended from 21 April 2026 to 30 April 2026....
This is intended to provide stakeholders with guidance and the requirements for medical device (including In Vitro Diagnostics (IVDs)) manufacturers, distributors and wholesalers who appoint or contract a third party to perform manufacturing, distribution or wholesaling activities on their behalf, for the purpose of placing...
The South African Health Products Regulatory Authority hereby issues an update to all Holders of Certificates of Registration (HCRs) of orally administered phenylephrine-containing medicines, following the communication dated 23 March 2026. Download previous version ...
This document is intended to provide communication to various stakeholders conducting Clinical Trials on allowed method for Serious Aderse Events (SAE) reporting to SAHPRA....
The purpose of the Medical Device Registration Feasibility Study was to support the South African Health Products Regulatory Authority (SAHPRA) in advancing the implementation of a comprehensive regulatory framework for medical devices, including in vitro diagnostics (IVDs), within South Africa. The study aimed to evaluate...
This document is intended to provide communication to all veterinarians and Veterinary Institutions in the Republic of South Africa to reinforce the importance of compliance with national legislation regarding the use of unregistered veterinary medicines. As stewards of animal health and welfare in South Africa,...
This notice provides an update to industry regarding Type II variation pilot submission windows....
The Medicines and Related Substances Act No. 101 of 1965 as amended makes provisions for the payment of retention fees to the South African Health Products Regulatory Authority (SAHPRA) in respect of medicines registered, medical devices, including in vitro diagnostics (IVDs), establishment licences issued. These...
The purpose of this document is to provide guidance to members of the public who intend to import Medical Devices/ In-Vitro Diagnostics (IVD) into the country for personal use....
This communication is intended to inform the relevant GDP license holders of the one-time renewal of expired GDP resolution letters. SAHPRA is introducing this initiative as a targeted measure to strengthen compliance management while addressing operational challenges. Frequently Asked Questions (FAQ): One-Time Renewal of Expired GDP...