A rapidly developed invasive or non-invasive ventilator classified as a Class C medical device in terms of the Medicines Act must comply with the latest version of the above referenced WHO specification (refer clause 6) and Appendix B of the MHRA specifications (refer clause 7), with adaptations in line with relevant South African legislation and standards, for purposes of emergency use during the Covid-19 pandemic in South Africa.

This guideline describes the following points;

  • Current Medical Device Licence and Regulatory Process
  • Hazardous Substances Act
  • Minimum Regulatory and Licensing Requirements for a manufacturer or distributor of a rapidly
    developed ventilator for emergency use during the Covid-19 pandemic
  • License Application Process and Timelines
  • Local manufacturers of invasive or non-invasive ventilators
  • Conditions of Licence and Authorisation for use of unregistered ventilators
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