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...
SAHPRA is committed to supporting regulatory convergence and harmonisation initiatives across the SADC Region to enhance timely access to quality, safe, and effective health products. In alignment with this goal, SAHPRA has implemented a reliance pathway utilising assessments conducted under the ZAZIBONA Centralised Procedure....
This communication is intended to guide relevant industries on the regulatory process for Magnetic Resonance Imaging (MRI) equipment. MRI equipment falls within the definition of electronic products and is classified as Group III under the Hazardous Substances Act 15 of 1973. MRIs are also listed...
This communication is aimed at guiding Applicants on the licensing process regarding the importation and use of laser systems in terms of the Hazardous Substances Act, Act 15 of 1973....
This communication is intended to guide license holders who import electromedical products through the annual submission of compliance information (ASOCI) process. This process is done in terms of section 5 of the Hazardous Substances Act 15 of 1973...
SAHPRA is committed to supporting regulatory convergence and harmonisation initiatives across the African continent to enhance timely access to quality, safe, and effective health products. In alignment with this goal, SAHPRA has implemented a reliance pathway utilising assessments conducted under the African Medicines Agency (AMA)...
The South African Health Products Regulatory Authority (SAHPRA) refers to Type II variation applications submitted under the Type II Pilot Programme and acknowledges the challenges experienced by certain applicants in finalising payment due to the different pricing calculation method applied through the Portal, as per...