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