Medical Devices

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  • 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: