Archive

09 Sep Guideline on Clinical Investigation of Medical Devices

Posted at 10:07h in

This guideline is intended to clarify the requirements of conducting a clinical investigation in a medical device in South Africa. It represents the South African Health Products Regulatory Authority’s (SAHPRA)’s current thinking on the safety, quality and performance of medical devices under clinical investigation. It...

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31 Jan Approval of a dosimetry service in South Africa

Posted at 12:03h in

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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07 Jan Recalls Vigilance Medical Devices IVDs

Posted at 13:18h in

This document has been archived....

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13 Dec Guideline for Completing Medical Device Adverse Event Form for Licensed Holders (Licensee) / Holders of a Certificate Of Registration of al Medical Device (including an IVD)

Posted at 10:31h in

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...

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20 Nov Guideline for the Sealing and Unsealing of Hazardous Substances

Posted at 09:03h in

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...

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16 Jul Guideline on Co-Applicancy

Posted at 12:01h in

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...

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24 Apr GWP Guideline for the Importers and Distributors of Scheduled Substances

Posted at 11:19h in

This guideline is intended to provide recommendations to applicants wishing to submit an application 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...

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16 Jan Guidelines For Users of Electronic Therapeutic Devices Emitting Ionizing Radiation

Posted at 13:55h in

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)....

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16 Jan Guideline for Import Applications of Electronic Devices Emitting Ionizing Radiation

Posted at 13:51h in

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....

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12 Oct Clinical Trials Committee and Submission Dates for 2024

Posted at 15:38h in

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. ...

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