IVDs

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  • Industry Meeting on Adverse Event Reporting for Medical Devices (including IVDs)

    Virtual

    The South African Health Products Regulatory Authority (SAHPRA) hosted an engagement session focused on training and guidance regarding SAHPRA’s requirements for Adverse Event reporting.   The purpose of the engagement was to enhance industry understanding and facilitate the effective implementation of Regulation 17 of the...

  • Regulatory Information Session on the Detention of Medical Devices and In Vitro Diagnostics (IVDs) at Ports of Entry

    Virtual

    The South African Health Products Regulatory Authority (SAHPRA), in partnership with major regulatory bodies, hosted a Regulatory Information Session for manufacturers, importers, distributors, authorised representatives, industry associations, and other stakeholders regarding the detention of medical devices and In Vitro Diagnostics (IVDs) at ports of entry....