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....
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This document is intended to assist the holder of a medical device establishment licence (referred to as the “licensee)” and the holder of a certificate of Registration (HCR) in the reporting of an adverse event associated with the use of a medical device (including an...
This guideline provides the information to be supplied to SAHPRA when completing the form to report an adverse event for a medical device (including an IVD), it outlines the format and data requirements for reporting of an adverse event, using the Medical Device Adverse Event...
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 guideline is intended to provide guidance to applicants who intend to apply as co-applicants for the registration of a medicine. It represents the current thinking of the South African Health Products Regulatory Authority (SAHPRA) on managing applications for registration where there is more than...
This guideline is intended to provide recommendations to applicants wishing to apply for a licence to import and /or distribute substances listed in the schedules in terms of the Medicines Act intended for use in the manufacturing and/or compounding of medicines or scheduled substances. Furthermore,...
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 is for Stakeholders to be aware of the South African Health Products Regulatory Authority (SAHPRA) Clinical Trials Committee meeting dates and the submission dates for the year of 2024. ...