Withdrawal of Section 21 Authorisation for use of unregistered rapidly developed non-invasive ventilators

Withdrawal of Section 21 Authorisation for use of unregistered rapidly developed non-invasive ventilators

In response to the anticipated shortage of medical supplies and equipment in the health care system as a result of the outbreak of the Covid-19 pandemic, the South African Health Products Regulatory Authority (the Authority) published minimum requirements for the manufacture, importation, and distribution of rapidly developed invasive and non-invasive ventilators in 2020.

2022 Jul

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File Type: pdf
Category: Communication to industry
Unit: Medical Devices