This document provides guidance on access to unregistered medicine for human use through the provisions of section 21 of the Medicines and Related Substances Act, 1965 (Act 101 of 1965), and clarifies the mandate, intent and scope of this section and regulation 29 of the...
Given that there is currently no credible evidence to support a therapeutic role for Ivermectin in COVID-19, SAHPRA has decided to terminate the Programme with immediate effect.
This guideline is intended to provide recommendations to applicants wishing to submit applications for the manufacture, importation, distribution and exportation of Class B, Class C and Class D medical devices and In Vitro diagnostics (IVDs). It represents the South African Health Products Regulatory Authority current...
2020 Mar...
This guideline is intended to provide recommendations to applicants wishing to submit applications for a licence to manufacture, import, distribute and export a medical device, including In Vitro diagnostics medical devices (IVDs). It represents the South African Health Products Regulatory Authority’s current thinking on the...
This guideline is intended to provide recommendations to interested persons wishing to submit applications for the licensing of manufacturers, distributors and wholesalers, and registration of medical devices and IVDs. It represents the Authority’s current thinking on the safety, quality and performance of medical devices and...
This guideline provides a reference document detailing the regulatory requirements for reporting of an adverse event for a medical device (including an IVD) in South Africa and describes the information to be supplied to the South African Health Products Regulatory Authority (SAHPRA). This guideline is...
This guideline is provided to outline the principles and process to be followed in the donation of medicines, medical devices and in-vitro diagnostics (IVDs). The guideline is applicable to both persons and entities wishing to make donations and the recipients of such donations. The South...
This guideline is intended to provide recommendations to applicants wishing to submit applications for the registration of Complementary Medicines containing specified substances. In addition to this guideline, SAHPRA reserves the right to request any additional information to establish the safety, quality and efficacy of...