Africa Adopts 2026–2035 Medical Products Regulation Strategy – What It Means for Device Registration and Market Access

In August 2026, African health ministers endorsed a landmark regional strategy that will reshape how medical products are regulated across the continent for the next decade. The Regional Strategy on Regulation of Medical Products in the African Region (2026–2035) was adopted at the Seventy-sixth session of the WHO Regional Committee for Africa in Addis Ababa.

Why This Matters

The strategy comes at a time when countries are expanding access to essential health products, strengthening local manufacturing, and preparing for future public health emergencies. Effective regulatory systems are fundamental to these efforts, ensuring that medicines, vaccines, blood products, diagnostics, and medical devices consistently meet internationally accepted standards of quality, safety, and effectiveness.

Progress and Gaps

Over the past decade, the African Region has made significant strides. The African Medicines Regulatory Harmonization initiative has expanded collaboration among countries, and the African Medicines Agency has become operational. The number of national regulatory authorities achieving WHO Maturity Level 3 – an internationally recognized benchmark 

indicating a stable and well-functioning regulatory system – has increased from one in 2018 to eight in 2025.

Yet significant gaps remain. Most countries continue to strengthen their regulatory capacity, and fragmented regulatory landscapes across 54 countries still force suppliers to navigate multiple registration processes, increasing time-to-market and compliance costs by an estimated 20–30% compared to harmonized regions.

The Strategy's Core Objectives

The new strategy outlines a roadmap to increase the number of regulatory authorities reaching WHO Maturity Level 3, support the development of authorities operating at internationally recognized performance levels, strengthen the African Medicines Agency, expand digital regulatory systems, and improve preparedness for future public health emergencies.

Critically, the strategy promotes greater collaboration through joint product assessments, shared inspections, and increased reliance on regulatory decisions made by trusted authorities. These approaches will help improve efficiency, reduce duplication, and accelerate access to quality-assured medical products.

Practical Implications for Medical Device Exporters

For companies seeking to enter or expand in African markets, this strategy signals both opportunity and obligation. The opportunity lies in the gradual emergence of mutual recognition pathways that could reduce the burden of registering products in multiple countries. The obligation lies in the accelerating shift toward higher regulatory standards.

As Dr Mohamed Yakub Janabi, WHO Regional Director for Africa, stated: "Strong regulatory systems protect lives, strengthen confidence in health systems and create the foundation for local innovation, manufacturing and faster access to quality-assured health products".

Exporters should prioritize selecting a core market for initial registration, leveraging reference approvals from FDA, CE, or WHO prequalification where possible, and working with experienced regulatory service providers to navigate the evolving landscape.