• Webinar – Good Regulatory Practices and its implementation in the Medical Devices Sector

    Virtual

    We are pleased to invite you to participate in an online webinar on “Good Regulatory Practices and its implementation in the Medical Devices Sector” that will take place on 10 and 11 August 2022 under the joint work of the COVID-19 Medical Device Regulatory Convergence Project (MDRC) and the South African Health Products Regulatory Authority (SAHPRA). The program for the event is attached which includes recognized subject matter experts from the World Health Organization and World Trade Organization, amongst others.

  • Virtual Meeting | Conformity Assessment Bodies Meeting

    Virtual

    The South African Health Products Regulatory Authority (SAHPRA), in collaboration with the South African National Accreditation System (SANAS), hosted a Conformity Assessment Bodies (CABs) Virtual Meeting. What was discussed? Extension of scope of practice to include technical dossier review SANAS Accreditation process SAHPRA requirements and future...

  • SAHPRA’s Medical Devices’ Registration Update – Upcoming Feasibility Study

    Virtual

    The Medical Devices Unit of the South African Health Products Regulatory Authority (SAHPRA) hosted an awareness session on this unit’s medical device registration update on the upcoming voluntary feasibility study. Date: 19 April 2024 Time: 10:00 to 13:00 Download Presentation Download Feasibility Study Watch Recording:

  • Medical Devices Stakeholder engagement Industry Meeting

    Virtual

    A Consultative meeting with the industry to communicate updates, and improve the application process, as well as the overall services and relations. Date: 28 June 2023 Time: 9h00 to 12h30 Watch Recording

  • Industry Stakeholder Engagement | Medical Devices Unit

    Virtual

    The Medical Devices Unit of the South African Health Products Regulatory Authority (SAHPRA) hosted a consultative meeting with Industry. The meeting aimed to communicate updates, ensure compliance with legislative requirements, discuss improvements to the application process, and enhance overall client service and relations. Areas of...

  • SAHPRA’s Regulatory Technical Forum (RTF) Virtual Meeting March 2025

    Virtual

    The South African Health Products Regulatory Authority (SAHPRA) recently hosted its Regulatory Technical Forum (RTF) Meeting, bringing together key industry stakeholders to discuss regulatory updates. Areas of discussion on the agenda included: BAU Applications and Variations Medicines (Allopathic) Veterinary Medicines Complementary Medicines Inspectorate and Regulatory...

  • SAHPRA’s Regulatory Technical Forum (RTF) Virtual Meeting – May 2025

    Virtual

    The South African Health Products Regulatory Authority (SAHPRA) recently hosted its Regulatory Technical Forum (RTF) Meeting, which brought together key industry stakeholders to discuss regulatory updates. Areas of discussion on the agenda included: Medicines (Allopathic) Clinical Updates Veterinary Medicines Complementary Medicines Inspectorate and Regulatory Compliance...

  • SAHPRA’s Regulatory Technical Forum (RTF) Virtual Meeting – August 2025

    Virtual

    Dear Stakeholder, You are invited to the South African Health Products Regulatory Authority’s (SAHPRA’s) Regulatory Technical Forum (RTF) Meeting. Areas of discussion on the agenda include: Medicines (Allopathic) Inspectorate Updates Veterinary Medicines Complementary Medicines Inspectorate and Regulatory Compliance Medical Devices & IVDs Legislation/Guidelines for Comment/Implementation...

  • Medical Devices Webinar | Industry Meeting on Regulatory Updates and Process Improvements

    Hybrid [Venue: Innovation Hub]

    The South African Health Products Regulatory Authority (SAHPRA) hosted a consultative meeting with industry to communicate updates, compliance to legislative requirements, improve the application process, and enhance overall client service and relations. Purpose of the webinar: Update on applicable fees SAHPRA’s services and processes Annual...

  • SAHPRA’s Regulatory Technical Forum (RTF) Virtual Meeting – November 2025

    Virtual

    The South African Health Products Regulatory Authority (SAHPRA) hosted a Regulatory Technical Forum (RTF) Meeting. Areas of discussion on the agenda included: Veterinary Medicines Medical Devices & IVDs Complementary Medicines Medicines (Allopathic) Inspectorate Updates Inspectorate and Regulatory Compliance Legislation/Guidelines for Comment/Implementation IT Upgrade   Recording

  • SAHPRA’s Regulatory Technical Forum (RTF) Virtual Meeting – March 2026

    Virtual

    The South African Health Products Regulatory Authority (SAHPRA) hosted the Regulatory Technical Forum (RTF) Meeting. Areas of discussion on the agenda included: Veterinary Medicines Medical devices & IVDs Complementary medicines Medicines (Allopathic) Inspectorate Updates Inspectorate and Regulatory Compliance Legislation/Guidelines for Comment/Implementation IT Upgrade   Presentations...

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

    Virtual

    The South African Health Products Regulatory Authority (SAHPRA) invites industry stakeholders to a targeted stakeholder engagement session focused on training and guidance regarding SAHPRA’s requirements for Adverse Event reporting.   The purpose of this engagement is to enhance industry understanding and effective implementation of Regulation 17...