An overview of the regulatory landscape for medical devices in Africa

• In Event: STS Africa: Infrastructures

Abstract

Although regulations for medical devices are important in promoting access to high quality, safe and effective medical devices, and in restricting the availability of products that put lives at risk, many African countries lack comprehensive regulatory frameworks. A review of ten African countries, namely Kenya, Nigeria, Egypt, Sudan, Morocco, Angola, Algeria, Tanzania, Ethiopia and South Africa, reveals that the existing regulations are fragmented and focus mainly on imports, as there are few local companies which manufacture products for the domestic and export markets. Controls are not yet well established to prevent the importation or use of sub-standard devices. This poses the risk of allowing sub-standard and poor quality medical devices to penetrate the market. None of the ten African countries reviewed have specific regulations or regulatory bodies dedicated to medical devices. Instead, the regulations pertaining to medical devices are presented within broader frameworks covering medicines, foodstuffs, cosmetics, and related substances. This is due to a lack of resources and of a critical mass of skilled personnel to focus solely on the regulation of medical devices. This approach may overwhelm regulatory bodies, resulting in cumbersome and inefficient regulatory approval processes. Medical devices are adversely affected by regulatory delays as some have a short life cycle before they become obsolete. African countries could strengthen the regulation of medical devices at regional level by working towards harmonisation and convergence with the aim of sharing best practices between national regulatory systems.

Authors

• Tania Douglas, University of Cape Town

• Trust Saidi, University of Cape Town