Licensing of ventilators being fast-tracked
In response to the shortage of ventilators in the healthcare system, as a result of the outbreak of the Covid-19 pandemic, the South African Health Products Regulatory Authority (SAHPRA) says it has drafted minimum regulatory requirements and technical specifications for the manufacture, import and distribution of rapidly developed invasive and noninvasive ventilators.
SAHPRA says it has also provided for an alternate, streamlined, expedited pathway for the licensing and Section 21 emergency-use authorisation of unregistered ventilators during the Covid-19 pandemic in South Africa.
The minimum requirements for the sale of rapidly developed invasive or noninvasive ventilators are that the establishment responsible for the manufacture, import, export or distribution of any ventilator is licensed by SAHPRA; the ventilator is specified as outlined in the Medicines and Related Substances Act, No 101, of 1965; and that it is authorised for emergency use in terms of Section 21 of the Medicines Act.
The Medicines Act and related legislation can be accessed at https://www. sahpra.org.za/acts-and- regulations/.
SAHPRA adds that the ventilators must comply with the latest version of the World Health Organisation technical specifications for invasive and noninvasive ventilators; Annexure B of the Medicines and Healthcare Products Regulatory Agency technical specification for rapidly manufactured continuous positive airway pressure; and the relevant South African legislation and standards.
The authority notes that the licence application process will be expedited, provided that the application submitted is complete and meets the applicable requirements, and that SAHPRA receives timely responses to any queries from the applicant.
Comments
The
content
you are trying to access is only available to subscribers.
If you are already a subscriber, you can Login Here.
If you are not a subscriber, you can subscribe now, by selecting one of the below options.
For more information or assistance, please contact us at subscriptions@creamermedia.co.za.
Option 1 (equivalent of R125 a month):
Receive a weekly copy of Creamer Media's Engineering News & Mining Weekly magazine
(print copy for those in South Africa and e-magazine for those outside of South Africa)
Receive daily email newsletters
Access to full search results
Access archive of magazine back copies
Access to Projects in Progress
Access to ONE Research Report of your choice in PDF format
Option 2 (equivalent of R375 a month):
All benefits from Option 1
PLUS
Access to Creamer Media's Research Channel Africa for ALL Research Reports, in PDF format, on various industrial and mining sectors
including Electricity; Water; Energy Transition; Hydrogen; Roads, Rail and Ports; Coal; Gold; Platinum; Battery Metals; etc.
Already a subscriber?
Forgotten your password?
Receive weekly copy of Creamer Media's Engineering News & Mining Weekly magazine (print copy for those in South Africa and e-magazine for those outside of South Africa)
➕
Recieve daily email newsletters
➕
Access to full search results
➕
Access archive of magazine back copies
➕
Access to Projects in Progress
➕
Access to ONE Research Report of your choice in PDF format
RESEARCH CHANNEL AFRICA
R4500 (equivalent of R375 a month)
SUBSCRIBEAll benefits from Option 1
➕
Access to Creamer Media's Research Channel Africa for ALL Research Reports on various industrial and mining sectors, in PDF format, including on:
Electricity
➕
Water
➕
Energy Transition
➕
Hydrogen
➕
Roads, Rail and Ports
➕
Coal
➕
Gold
➕
Platinum
➕
Battery Metals
➕
etc.
Receive all benefits from Option 1 or Option 2 delivered to numerous people at your company
➕
Multiple User names and Passwords for simultaneous log-ins
➕
Intranet integration access to all in your organisation