Medical device regulation in South Africa : the Medicines and Related Substances Amendment Act 14 of 2015

The Medicines and Related Substances Amendment Act 14 of 2015 has brought significant changes in the regulation of medical devices in South Africa (SA). The highlights include the establishment of a regulatory authority – the SA Health Products Regulatory Authority – the introduction of a tier-based licensing and registration system, and the restriction of bonusing and sampling for the sale of medical devices. The enactment of the new regulations is a positive development for the SA medical device industry. However, the impact depends on the implementation of these regulations. Conditions that will support the success of the regulations include creating a critical mass of skilled personnel and measures that ensure timely registration. SA can learn from the experiences and practices of other countries that have introduced medical device regulations in recent years.