Regulating IVDs in Africa: Balancing Innovation and Patient Safety
In vitro diagnostics (IVDs) have quietly become one of the most powerful tools in healthcare. From a rapid test that can confirm malaria in minutes, to advanced molecular diagnostics that detect cancer markers, these technologies are reshaping how we diagnose and monitor disease.
In Africa, where health systems are under pressure from both infectious and non-communicable diseases, IVDs hold the promise of faster, more affordable, and more accurate care. But with that promise comes a challenge: how do we encourage innovation while ensuring patient safety?
Regulation of IVDs in Africa is still evolving. A few countries, like South Africa, Egypt, and Morocco, have more established systems. Others are just beginning to define their frameworks.
At the continental level, initiatives like the African Medicines Agency (AMA) and the African Medical Device Forum (AMDF) are laying the groundwork for harmonized policies. Regional blocs such as the East African Community (EAC) and the Southern African Development Community (SADC) are also experimenting with shared guidelines.
Yet, for most manufacturers, bringing an IVD to Africa still means navigating a patchwork of country-specific rules, documentation demands, and timelines.
The Key Challenges:
- Capacity gaps: Many regulators don’t yet have enough trained staff or laboratories to evaluate complex devices, leading to delays and uneven oversight.
- Fragmentation: With more than 50 national markets, requirements are inconsistent and often duplicated.
- Keeping pace with innovation: Technologies like AI-enabled diagnostics or rapid point-of-care tests move faster than regulations can adapt.
- Weak post-market surveillance: Systems for reporting adverse events and recalling products are still underdeveloped in many regions.
These challenges create bottlenecks for industry and, more importantly, slow down patient access to life-saving tools.
Despite the hurdles, there is real progress. Reliance models are gaining traction — some regulators now accept WHO Prequalification or approvals from mature authorities like the FDA or EMA as reference points. This approach reduces duplication and speeds up decision making.
Capacity-building efforts led by the WHO, African Union, and public-private partnerships are also making a difference. Training programs are helping regulators sharpen their expertise, while digital platforms are streamlining submissions and improving traceability.
And with Africa’s growing focus on local manufacturing, governments are beginning to recognize the importance of clear, predictable regulatory pathways that encourage investment without lowering safety standards.
So, how can Africa move forward? A few guiding principles stand out:
- Adopt risk-based frameworks that apply stricter controls to higher-risk products while easing requirements for lower-risk ones.
- Leverage international standards and reliance pathways to save time and resources.
- Strengthen post-market surveillance so regulators can respond quickly if problems arise.
- Encourage collaboration between authorities, industry, and healthcare providers to ensure policies evolve with technology.
- Support local innovation and manufacturing with transparent, fair, and regionally harmonized rules.
These topics aren’t just theoretical; they are at the heart of ongoing discussions among Africa’s regulatory and healthcare leaders. MedDevReg AfriSummit 2025 will feature a dedicated session on IVD regulation, bringing together regulators, industry experts, and innovators to explore how the continent can balance innovation and patient safety in diagnostics.
If you are involved in regulatory affairs, medical devices, or healthcare policy, this is a conversation you won’t want to miss. The summit offers a unique opportunity to share experiences, learn from best practices, and contribute to shaping the future of IVD regulation in Africa.
Africa stands at a crossroads. The continent has the chance not only to catch up but to leap ahead in creating smart, patient-centred regulation for IVDs. By balancing innovation with safety, regulators can help ensure that diagnostics reach those who need them most — quickly, reliably, and affordably.
This important conversation will continue at MedDevReg AfriSummit 2025 during the session dedicated to IVD regulation. To join the discussion and register for the summit, visit www.pharmaregafrisummit.com.
