Radiation Control Archives

31 Mar Guideline for Transportation Security for Radioactive Material

Posted at 14:54h in

This guideline specifies the basic security conditions for obtaining a transport authority for Group IV hazardous substances as defined in the Hazardous Substances Act 15 of 1973, referred to in this guideline as radioactive material. This represents the guidance of the South African Health Products...

25 Feb Guideline for the Application of a License to Install, Use, Operate, and Apply for Magnetic Resonance Imaging (MRI)

Posted at 09:06h in

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...

25 Feb Guideline for Licence Applications for Non-ionising Radiation Medical and Non-medical Devices Classified as Listed Electronic Products

Posted at 09:04h in

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....

16 Feb Regulatory Process for Magnetic Resonance Imaging (MRI) Equipment

Posted at 13:42h in

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...

16 Feb Regulatory Requirements for License Applications for Importation, Manufacturing and Use of Laser Systems

Posted at 13:40h in

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....

16 Feb Regulatory Process of Annual Submission of Compliance Information (ASOCI)

Posted at 13:38h in

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...

03 Feb Guidelines for distributors and transporters of sealed sources

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...

18 Nov Core Business Escalation Procedure

Posted at 10:18h in

This document intends to provide clarity on SAHPRA’s Core Business Escalation procedure, to enable effective and efficient communication between SAHPRA and its stakeholders....

17 Nov Guideline for Users of Ultra-portable X-ray Equipment

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...

08 Apr Communication Regarding the Sealing and Unsealing of Hazardous Substances

Posted at 11:40h in

This document intends to communicate to all the users of Group III and IV hazardous substances about the processes of sealing and unsealing the equipment. The sealing of dangerous substances is an enforcement action and may occur during announced and/or unannounced inspections or in the...

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