The shortage of ventilators during the COVID-19 pandemic has seen numerous manufacturing companies move from their traditional industries such as motor-vehicle, industrial and mining, to the life sciences industry and more specifically the manufacturing of ventilators.
The manufacture, production, distribution and sale of ventilators are regulated by the Medicines and Related Substances Act No 101 of 1965 as amended (“Medicines Act”) and the South African Health Products Regulatory Authority (SAHPRA).
In order for a company to manufacture or import/export a Ventilator (both invasive and non-invasive), they must obtain a medical device establishment licence from SAHPRA to make such activities legal. The product will be registered in the specific class of devices based on the classification rules of SAHPRA.
A registration with SAHPRA for the manufacture or import of a ventilator under normal circumstances takes between 8-10 weeks but is currently fast-tracked with a turnaround time of seven days.
Important to note that where the design of a ventilator is already internationally approved, it can usually be accepted by SAHPRA, but in the case of a new design or product, a more extensive and expert evaluation would be required and will result in longer turn-around times.
Since ventilators are deemed as a higher risk medical device (determined by the level of invasiveness and duration of use of a product), an applicant for registration must prove that the ventilator fulfils various criteria in terms of safety and performance.
The criteria is provided by SAHPRA and considered during the application review process. There are further requirements for quality management and post-market vigilance amongst others, which must also be adhered to in order for a medical device to be registered and made available on the South African market.
In addition to the process for registration of Ventilators available at SAHPRA, the Department of Trade and Industry and Competition (“DTIC”) launched the National Ventilator Project (NVP) to ensure that the need for enough ventilators is met. The NVP called for proposals for a non-invasive (pre-intubation) ventilator in order to identify role players in the industry able to assist the DTIC to meet the anticipated demand in this regard.
It is important to understand the difference between a ventilator and a non-invasive (pre-intubation) ventilator for purposes of registering the medical device in the correct class of devices with SAHPRA.
A ventilator is a medical device used to support breathing by means of an endotracheal tube (ET tube) being placed in the trachea (windpipe) under local anaesthesia with sedation or general anaesthesia. This ET tube is connected to a mechanical ventilator using appropriate connection tubing. The ventilator senses the breathing needs of an individual and gives appropriate pressures to inflate the lungs to either replace the breathing efforts of the individual or supplement spontaneous breathing in various disease conditions.
A non-invasive ventilator is usually a smaller medical device with less sophistication. It is connected using an external mask which is tight fitting over the nostrils and mouth of an individual. A good air seal at the mask-face interface is required to ensure proper functioning of non-invasive ventilators. The advantage however is that the individual can remain fully alert without any need for sedation or anaesthesia. There is also no need to place an ET tube in the trachea, which substantially lowers the level of invasiveness and risk for complications such as damage to the vocal cords, bleeding, infection and aspiration, tearing or puncturing of tissue in the chest cavity which can lead to lung collapse and injury to the throat or trachea. It is this lowered complication-risk which makes the non-invasive (pre-intubation) ventilator a good choice in effectively treating respiratory symptoms of COVID-19.
From the information made available by the Department of Health, SAHPRA and the DTI it is clear that government is fully engaged and prepared to work with industry stakeholders and those wanting to enter the Life Sciences Industry to assist with the fight against COVID-19.
For more information you can contact Martha Burnett (née Smit)