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

Abstract

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