Abstract

This article examines the regulation of health-related direct-to-consumer genetic tests (‘HDGTs’) in South Africa by the Medicines and Related Substances Act 101 of 1965 and its related regulations, namely the Regulations Relating to Medical Devices and In Vitro Diagnostic Medical Devices and the draft Regulations Relating to Medical Devices, as well as the South African Health Products Regulatory Authority guidelines. Such regulation includes the classification, licensing, registration, marketing, labelling and importing of HDGTs. At a basic classification level, the manufacturer’s intention determines whether HDGTs are medical devices and/or in vitro diagnostic devices (‘IVDs’). Those HDGTs that are medical devices are also likely to be IVDs and are likely to be classified as Class B IVD medical devices, meaning that they pose low to medium risk. This is because the intended use of an HDGT is generally not as a diagnostic tool but as an informational tool, where the results are not definitive and additional testing is required. Accordingly, a licence is required to manufacture, import, export, sell or distribute HDGTs in South Africa. The classification of HDGTs also impacts the rules relating to labelling, advertising and importation.