Towards a medical device regulation in South Africa: an assessment of the medicines and related substances amendment act of 2015

© 2016, IUPESM and Springer-Verlag Berlin Heidelberg.The medical device industry in South Africa was conspicuous by the absence of a comprehensive system of regulation until the enactment of the Medicines and Related Substances Amendment Act of 2015. There were no specific regulations governing the sale and use of medical devices in South Africa, except for the electro medical devices, which were regulated by Radiation Control, an agency of the Department of Health. The new legislation is an important landmark in the history of medical devices regulation in South Africa. This paper explores the importance of medical device regulation in promoting access to high quality, safe and effective medical devices as well as restricting the use of products that put lives at risks. It assesses the impacts of the absence of medical device regulation in South Africa during the previous years and move forward to analyse the Medicines and Related Substances Amendment Act of 2015 in terms of its effectiveness to regulate medical devices in South Africa.