Section 21 extension (Ventilators – invasive and non-invasive)

07 June 2021

To whom it may concern  
We draw your attention to the provisions of Section 21 of the Medicine and Related Substances Act, 1965 (Act 101 of 1965), to authorise the sale of unregistered medicines or medical devices for certain purposes. The communication reference MD029 Currently on our SAHPRA website (www.sahpra.org.za) as a reminder to all affected stakeholders on the Section 21 renewal. Kindly note the content of the communication.
Reference: For further information refer to MD010 “Regulatory Requirements, Technical Specifications, Licence Conditions and Authorisation for Use of Unregistered Rapidly Developed Invasive and Non-Invasive Ventilators for Covid-19” published
Response contact: by email mdcovid@sahpra.org.za and copy on Matlapeng.shabalala@sahpra.org.za

Communication to Industry