Archive

09 Oct SAHPRA ECTD Specification 3.1 and Guidance for Module 1 and Regional Information

Posted at 18:02h in

This guideline is intended to provide recommendations to applicants wishing to submit applications for the registration, as well as variations, of medicines in eCTD format. It reflects the current situation and will be regularly updated with changes in legislation and experience gained. It is important...

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01 Oct Guideline on Traceability of Health Products

Posted at 14:31h in

The purpose of the document is to guide the implementation of global standards for product identification, data capture, and data sharing. It represents the South African Health Products Regulatory Authority’s (SAHPRA)’s current thinking on the safety, quality and efficacy of medicines. The implementation of unique...

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09 Sep Post Market Surveillance and Post-market Clinical Follow-up Studies

Posted at 10:34h in

This guideline is intended to provide recommendations to Manufacturers, Importers, Exporters, Distributors, and Holders of certificates of Registration (HCR) of medical devices. It represents the South African Health Products Regulatory Authority’s (SAHPRA) current thinking on the safety, quality, and performance of medical devices. It is...

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09 Sep Guidelines on Clinical Evaluation of Medical Devices

Posted at 10:33h in

This guideline is intended to clarify the requirements of conducting a clinical evaluation of 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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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 Medical Device Adverse Event Reporting Form

Posted at 11:04h in

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...

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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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