Archive
29 Feb Minimum Requirements For Establishment of Internal Rules
Posted at 13:06h
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This document is intended to provide communication to applicants and holders of authorities of activities regulated by the Hazardous Substances Act, Act 15 of 1993 and amended regarding the requirements for internal rules that must be drawn up terms of Regulation 7 of the Regulations...
16 Jan Guidelines For Users of Electronic Therapeutic Devices Emitting Ionizing Radiation
Posted at 13:55h
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This Guideline sets out requirements for radiation safety associated with the use of therapeutic devices emitting ionizing radiation. The Hazardous substances Act, 1973 (Act 15 of 1973) and Regulations (No R1332 of 3 August 1973)....
16 Jan Guideline for Import Applications of Electronic Devices Emitting Ionizing Radiation
Posted at 13:51h
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This guideline sets out the requirements and recommendations when applying for a license to import any electronic device emitting ionizing radiation. The Hazardous Substances Act 15, 1973....
02 Oct SAHPRA position on EU regulatory transition for medical devices from MDD/AIMDD/IVDD to MDR 2017/745 /IVDR 2017/746
Posted at 09:49h
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This communication to industry refers to the Medical Device Unit and Radiation Control Unit publishing SAHPRA’s position on EU regulatory transition for medical devices from MDD/AIMDD/IVDD to MDR 2017/745 /IVDR 2017/746....
14 Mar Application for a licence to use an MRI device (veterinary)
Posted at 11:15h
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Section 4(1)(b)&(c), Hazardous Substances Act, 1973....
14 Mar Application for a licence to use an MRI device (medical)
Posted at 11:14h
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Section 4(1)(b)&(c), Hazardous Substances Act, 1973....
14 Mar Application for a licence to use a non-medical laser
Posted at 11:12h
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Hazardous Substances Act, 1973 (Act 15 of 1973)...