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30 Mar

Posted at 09:11h in

This document has been prepared as a guideline for preparing applications to conduct clinical trials in South Africa. It represents the South African Health Products Regulatory Authority’s (SAHPRA) current thinking on pregnancy and lactation for clinical research in South Africa. It is not intended as...

27 Mar

Posted at 14:53h in

This document has been prepared to serve as a guideline to clarify the requirements of insurance for those who conduct interventional clinical trials involving human participants and intend on making a submission for approval of a clinical trial by South African Health Products Regulatory Authority...

26 Mar

Posted at 15:05h in

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...

25 Feb

Posted at 11:36h in

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...

03 Feb

Posted at 15:06h in

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...

17 Nov

Posted at 12:50h in

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...