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Medical Devices And In Vitro Diagnostics Guidelines

Document NumberTitleCategoriesDate UpdatedVersionUnitsFile TypeLinkdoc_categories_hfilterdoc_tags_hfilter
8.04 (Archived)Recalls Vigilance Medical Devices IVDs14/11/20192Downloadguidelinemedical-devices
GLF-MD-11AMedical Device Adverse Event Reporting Form13/12/20241docxDownloadguidelinemedical-devices
SAHPGL-MD-11Guideline for Completing Medical Device Adverse Event Form for Licensed Holders (Licensee) / Holders of a Certificate Of Registration of al Medical Device (including an IVD)13/12/20241pdfDownloadguidelinemedical-devices
SAHPGL-MD-07Guideline on Questions and Answers Licensing of Medical Device Establishments, 17/11/20233pdfDownloadfaq guidelinemedical-devices
8.01 (Archived)General Information Medical Devices And IVDs13/08/20141Downloadguidelinemedical-devices
8.06 (Archived)Guideline For Access To And Control Of Medical Devices And IVDs18/04/20171Downloadguidelinemedical-devices
SAHPGL-MD-06Guideline for a License to Manufacture, Import, Export, or Distribute Medical Devices and IVDs23/03/20233pdfDownloadguidelinemedical-devices
SAHPGL-MD-05Guideline on Medical Device Quality Manual14/03/20234pdfDownloadguidelinemedical-devices
SAHPGL-MD-04 Guideline for Classification of Medical Devices and IVDs15/03/20244pdfDownloadguidelinemedical-devices
SAHPGL-MD-03 (previously 8.04)Guideline for Medical Device Adverse Event Reporting13/12/20244pdfDownloadguidelinemedical-devices
8.02 (Archived)Medical Device IVD Essential Principles14/11/20192Downloadguidelinemedical-devices
Notice Regarding Medical Devices ADR Guideline

Dear Visitor

On 13 December 2024, SAHPRA published Approved guidelines for the management of medical device vigilance, including the Adverse Event reporting form for medical devices including IVDs.  

The guideline SAHPGL-MD-03_v4 Guideline for Medical Device Adverse Event Reporting, in relation to the reporting of adverse events for medical, replaces 8.04 Recalls Vigilance Medical Devices IVDs. However, it will still be applicable to be used as a guide for the information related to Field Safety Corrective Actions (FSCA) and recalls for medical devices. Reports and/or queries related to FSCA’s and recalls are to be directed to recalls@sahpra.org.za

Applicants that have previously submitted adverse events reports in the old format are urged to make use of published adverse event reporting form.

Regards,
Medical Devices Unit

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