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Industry Stakeholder Engagement | Medical Devices Unit

November 26, 2024 @ 10:00 am - 1:00 pm

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 discussion included:

  • Payment of applicable fees
    • Annual retention fees (including cancellation licences for non-compliant licence holders)
    • Licence fees
  • Renewal applications
  • Guidelines for the management of medical device vigilance
  • ISO 13485 Certification – implementation plan for April 2025

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  • Virtual