This document has been prepared to serve as a guideline for applicants/investigators who wish to submit the application to conduct a clinical trial, application for additional sites, and additional investigators for an approved trial....
This guideline is intended to provide guidance on obtaining a Certificate of Free Sale, which serves as confirmation that the listed medical devices, including in vitro diagnostic medical devices (IVDs), are legally sold or distributed in the market in South Africa, freely without restriction. It...
This guideline outlines the principles and procedures for reliance-based review in both premarketing and post-marketing regulatory activities for medical devices, including in vitro diagnostics (IVDs). It defines the Regulatory Reliance pathways that the South African Health Products Regulatory Authority (SAHPRA) will use in making regulatory...
The purpose of this document is to guide applicants seeking a license to install and use Magnetic Resonance Imaging (MRI) equipment. It outlines the necessary processes involved in applying for a license, the required supporting documents, and safety requirements. This guideline represents the minimum standards...
This guideline is intended to guide applicants wishing to submit applications for the listed electronic products. It represents the South African Health Products Regulatory Authority's (SAHPRA)’s current thinking on the safety, quality, and performance of the listed electronic products....
This guideline document deals with compiling and submitting sealed source monthly reports. It also deals with the cradle-to-grave racking process to account for all sealed radioactive sources that are used in South Africa. The tracking covers the manufacture, storage, use, transport, disposal (sale, transfer or...
This guideline sets out requirements and recommendations for radiation safety associated with the use of ultra-portable diagnostic X-ray equipment. It represents the South African Health Product Regulatory Authority’s (SAHPRA) current thinking on the safety, efficacy, and quality of X-ray equipment. The Hazardous Substances Act, 1973...
This document provides guidance regarding safe disposal and destruction of medicines and scheduled substances by health facilities in accordance with Regulation 44 of the General Regulations of the Medicines and Related Substances Act, 101 of 1965, and relevant waste legislation. To ensure the correct handling...
This guideline is intended to provide recommendations to applicants wishing to submit applications for the registration of Human Medicines (Categories A and D) containing specified substances. Regarding Category D medicines, the guidance provided herein pertains to general content requirements. Any specific technical guidance indicated in...
All guidelines adopted by the South African Health Products Regulatory Authority (SAHPRA) from the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) must be read in conjunction with the current, non-draft version of SAHPRA’s Guide to Good Manufacturing Practice for...
