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...
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 document intends to provide clarity on SAHPRA’s Core Business Escalation procedure, to enable effective and efficient communication between SAHPRA and its stakeholders....
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 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...
This guideline sets out the requirements for the approval of a dosimetry service to operate in South Africa and provide passive monitoring of radiation workers....
This document is intended to provide communication on conditions for Veterinary X-Ray Licence Holders. ...
This guideline intends to narrate the critical framework of sealing and unsealing hazardous substances. It stipulates all enforcement actions necessary, according to the Hazardous Substance Act, 15 of 1973 with respect to Grouped Hazardous Substances, related regulations and prescribed licence conditions, that may be imposed...
This letter shows routine inspection was carried out at a premises....
This letter grants permission to name of Technician of name of IB to remove the seal from the x-ray unit at the premises of the licence holder....