28 Feb Guideline on Questions and Answers Licensing of Medical Device Establishments
Posted at 19:16h
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Archive
20 Feb Guideline on Co-packaging of Medicines
Posted at 10:08h
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This guideline is intended to provide guidance to applicants regarding applications for registering co-packaged medicines. It represents the South African Health Products Regulatory Authority (SAHPRA) current thinking on co-packaging of medicines. SAHPRA reserves the right to request any additional information to establish the safety,...
07 Feb Guideline for Fixed Dose Combination Products (FDC Products) for HIVAIDS, Tuberculosis and Malaria
Posted at 18:59h
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This guideline is intended to provide recommendations to applicants wishing to submit applications for the registration of medicines.
Archives
Download Version 2 (2.31)Date updated
...21 Nov General Information Medical Devices And IVDs
Posted at 12:20h
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This document has been archived.
Archives
Download Version 1 (8.01)Date updated
...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This document has been archived.
Archives
Download Version 1 (8.06)Date updated
...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.
Archives
Dental Radiography GuidelinesDate updated
...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.
Archives
Download Version 2Date updated
...15 Aug Guideline For Code Of Practice For Users Of Non – Medical X-RAY Equipment – Forensic
Posted at 21:46h
in
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.