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.
When we talk about access to healthcare, the conversation often focuses on availability: Is the product in the country? Can the facility afford it? Can the patient access it?
But there is another question behind all of these: what makes a health product trustworthy enough to reach the patient in the first place?
The answer is regulation. Regulation begins with law: a country's formal commitment to define what is permitted, what is required, and who is accountable. But law is only the foundation. For health products, whether that foundation translates into safe, quality, performant products on the ground depends on what is built on top of its guidelines, enforcement capacity, and oversight once the product is on the market.
The question we set out to answer was how far that commitment extends once we move from medicines to medical devices and in-vitro diagnostics (IVDs).
What exactly are we regulating?
Medical devices are much broader than the equipment we traditionally picture in a hospital.
The WHO Global Model Regulatory Framework for Medical Devices, including IVDs, defines them broadly: instruments, machines, implants, software, materials, and other products intended for diagnosis, prevention, monitoring, treatment, or support of physiological processes — where the primary intended action is not pharmacological, immunological, or metabolic. IVDs are the subset intended for the in-vitro examination of human specimens to provide diagnostic, monitoring, or compatibility information.[1]
In short: a medical device diagnoses, monitors, treats, or prevents without relying on chemical action. An IVD does this by analyzing biological samples outside the body — chemistry analyzers measuring electrolytes, for instance — to inform a diagnosis.
Whether a product is classified as a device or an IVD determines the specific pathway and evidence a regulator will require. But the underlying questions a system must be able to answer are the same across both: Is it safe? Does it perform as intended? Is its quality consistent, batch to batch? Is there sufficient evidence for its intended use? And critically — what happens when something goes wrong after it reaches the market?
The answers require more than a law. They require a functioning regulatory system. Africa has regulations. The question is how far it goes.
To understand this landscape more closely, a dataset covering all 54 African countries was developed and cross-referenced against WHO indicators and survey data.[2] For each country, five questions were examined using primary sources, primarily national regulatory authority and government websites:
Does the country have laws governing health products and technologies?
Do those laws explicitly cover medical devices and IVDs?
Are there specific guidelines for regulating MDs and IVDs?
Do those guidelines reference an international or regional framework?
Which specific standards or frameworks are referenced?
What the Data Showed
Out of the 54 countries reviewed, 47 (87%) have laws governing health products and technologies in some form. Of those, 44 (82% of all 54) explicitly extend that legal coverage to medical devices and IVDs. The picture narrows sharply from there: only 26 countries — 48% of the continent — have published specific guidelines for regulating MDs and IVDs.
This is the gap that matters most. A law establishes regulatory authority in principle. A guideline is what makes that authority operational — the document a manufacturer, distributor, or assessor works from.
Where countries have closed the guideline gap, they have largely done so by drawing on structures they already belong to, rather than building alone. UEMOA member states have used their existing regional community to build a shared regulatory framework.[3]Separately, a few African countries who hold affiliate membership with the International Medical Device Regulators Forum (IMDRF) have leveraged on the existing frameworks.[4] The internationally recognized quality management standard for medical devices (ISO 13485) has also been widely used as a reference for the guidelines used by these countries.
Why the Gap Still Exists Elsewhere
Where countries haven't yet closed this gap, the shortfall is rarely a failure of ambition. Where reasons could be identified, they typically traced to limited in-country regulatory expertise, the absence of an accessible framework to adapt from, or institutional disruption in specific contexts.
This does not mean health products are absent from these markets. Products continue to move across borders and into facilities through a range of national arrangements. The more consequential question is what sits — or doesn't — behind that access.
The Takeaway
Regulation is not a barrier to access; it is what makes access trustworthy. The countries furthest ahead on this gap are not necessarily the ones with the most resources — they are the ones that have made the most of the regional and international communities already available to them.
This project is part of our ongoing work to understand and translate the regulatory frameworks for medical devices and in-vitro diagnostics in Africa with a focus on supporting ongoing national and regional efforts to strengthen regulatory systems. Additionally, this positions our ongoing and growing work supporting industry with market access strategies in the continent. We believe the best way we can serve our clients is through in-depth understanding of the markets where we operate and not only working with what is but challenging what exists to reimagine what the system could be.
By: Prudence Ibila | Biomedical Engineer | Market Access & Ecosystem Enablement Intern
WHO Global model Regulatory Framework for medical devices including in-vitro diagnostic medical devices, Annex 3 https://www.who.int/publications/m/item/who-global-model-regulatory-framework-for-medical-devices-including-in-vitro-diagnostic-medical-devices--annex-3
The Global Health Observatory https://www.who.int/data/gho/data/indicators/indicator-details/GHO/unit-in-the-ministry-of-health-responsible-for-the-management-of-medical-devices
UEMOA. Bulletin Officiel de l'Union N°113, deuxième trimestre 2022 (règlement relatif aux dispositifs médicaux).https://www.uemoa.int/sites/default/files/bibliotheque/bulletin-officiel-ndeg113-de-luemoa-deuxieme-trimestre-2022.pdf ↑
International Medical Device Regulators Forum (IMDRF). Official site and affiliate/member listing. https://www.imdrf.org/about/affiliate-members