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...
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)....
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....
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....
Application for a Licence to Use Operate Apply Install or Keep Installed an MRI Device System (Veterinary) APPLICATIONS MUST ONLY BE SENT THROUGH DESIGNATED EMAIL ADDRESSES: Applications: nirmed.application@sahpra.org.za Enquiries: nirmed.enquiry@sahpra.org.za ...
Application for a Licence to Use Operate Apply Install or Keep Installed a Magnetic Resonance Imaging (MRI) Device System (Medical) APPLICATIONS MUST ONLY BE SENT THROUGH DESIGNATED EMAIL ADDRESSES: Applications: nirmed.application@sahpra.org.za Enquiries: nirmed.enquiry@sahpra.org.za ...
Hazardous Substances Act, 1973 (Act 15 of 1973)...
Section 4(1)(b)&(c), Hazardous Substances Act, 1973 (Act 15 of 1973)....
Application for a Licence to Import a New Listed Electromagnetic Product APPLICATIONS MUST ONLY BE SENT THROUGH DESIGNATED EMAIL ADDRESSES: Applications: nirmed.application@sahpra.org.za Enquiries: nirmed.enquiry@sahpra.org.za Annual information compliance (ASOCI): radcon.asoci@sahpra.org.za ...