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.