21 Nov Guideline For Access To And Control Of Medical Devices And IVDs
Posted at 12:08h
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This document has been archived....
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10 Nov Risk Management Plans for Medicines for Human Use
Posted at 09:46h
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This document has been prepared to serve as a guideline to the holders of certificate of registration/applicants on the Authority’s requirements regarding risk management plans for medicines, including biological medicines, in South Africa. It represents SAHPRA’s current thinking on the safety, quality and efficacy of...
02 Sep Guideline for Disposal of X-Ray Units and Tubes Containing Beryllium
Posted at 09:46h
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The objective of this guideline is to provide X-Ray equipment licence holders on how and where to dispose of electronic equipment that has reached the end of life. The unit must be confirmed to be in a state where it will never be used for...
15 Aug Guideline for Dental Radiography
Posted at 21:52h
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This guideline document determines basic requirements and recommendations for radiation protection and safety in dental radiography applications....
15 Aug Guideline Radiologist Available by Remote Digital Connection
Posted at 21:49h
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To provide guidance when applying to license to Use a Computed Tomography system where a Radiologist is available only by remote connection....
15 Aug Guideline For Code Of Practice For Users Of Non – Medical X-RAY Equipment – Forensic
Posted at 21:46h
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This guideline is intended to help healthcare professionals in the forensic field who are tasked with acquiring rays of deceased individuals to protect themselves from the dangers of ionizing radiation....
15 Aug Guideline for Code of Practise for Industrial Radiography X-Ray
Posted at 21:45h
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X-Ray equipment used in industrial radiography is subject to regulatory control in terms of Article 3(1) of the Hazardous Substances Act, 1973 (Act 15 of 1973), as amended. The body responsible for administering this legislation is SAHPRA: Radiation Control. This code of practice has been...
15 Aug Guideline for Bone Densitometer – Operators
Posted at 21:41h
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The following recommendations serve as guidelines for shielding, monitoring, and positioning of operators during dual-energy X-Ray absorptiometry (DXA)....
15 Aug Guideline for Monitoring of Radiation workers in a Theatre
Posted at 21:37h
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This document has been prepared to serve as a guideline in monitoring Radiation workers in a Theatre. It represents South African Health Products Regulatory Authority’s (SAHPRA’s) current thinking on the safety, quality and efficacy of medicines. It is not intended as an exclusive approach. SAHPRA...
15 Aug Guideline for Minimum Requirements For Fixed Diagnostic X-Ray Installations
Posted at 21:35h
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This guideline stipulates the regulatory requirements for installations of fixed diagnostic X-ray units. Every medical diagnostic X-ray must meet the design safety specifications outlined in this document. The manufacturer / vendor must obtain a license to install from South African Health Products Regulatory Authority (SAHPRA)...