Healthcare Regulation23 September 2026
An Overview of Africa’s Medical Device/IVD Regulatory Landscape
This article explores Africa’s regulatory landscape for medical devices and in-vitro diagnostics, highlighting the difference between having health product laws and having practical guidelines that make regulation work. Based on a review of all 54 African countries, it finds that while most countries have legal frameworks for health products, fewer have specific guidelines for medical devices and IVDs. The article argues that regulation is not a barrier to access, but a foundation for ensuring that products reaching patients are safe, effective, reliable, and properly monitored. It also shows how countries are using regional and international frameworks, including UEMOA, IMDRF, and ISO 13485, to strengthen regulatory systems and support market access across the continent.
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