The State of Medical Technology in Africa — 2025 Opportunities & Challenges

Executive summary (TL;DR)

Africa’s medical technology landscape in 2025 sits at an inflection point. Significant momentum — new continental institutions, major financing pledges, growing local manufacturing pilots and a rising generation of medtech entrepreneurs — is converging with long-standing systemic barriers: fragmented regulation, weak maintenance ecosystems, constrained financing and fragile supply chains. The result is a window of rare opportunity: with coordinated public-private action Africa can turn import dependence into a resilient regional medtech industry that improves access, reduces cost and fuels economic growth. This article synthesizes the current state, the most important opportunities, the realistic barriers, and pragmatic next steps for senior decision-makers.

1. Where we are in 2025 — a snapshot

• Institutional momentum. The African Medicines Agency (AMA) treaty entered into force in 2021 and the agency is moving from setup to operationalization — a rare continental mechanism that can harmonize regulation for medicines, diagnostics and medical devices. Several policy and support initiatives (PATH, AU, WHO partnerships) are actively helping countries ratify and operationalize AMA commitments.

• Manufacturing push. Africa is accelerating local production of vaccines, diagnostics and health products: partnerships, transfers and new plants are being announced, and multilateral finance (AfDB and partners) is being mobilized to scale manufacturing capacity. Examples include government-backed programs and an AfDB industry push that aims to put billions into health manufacturing infrastructure. (avmi-africa.org)

• Market dynamics. Recent industry analyses estimate the African medical-devices market to be in the multi-billion dollar range with steady growth, driven by population growth, non-communicable diseases and expanding hospital networks. Exact estimates vary by source, but consensus points to meaningful, multi-year growth potential. (Meticulous Research)

• Local successes & proof-points. Home-grown diagnostic producers and device innovators are emerging: for example, a Moroccan company developed and supplied mpox tests regionally, demonstrating that African firms can produce diagnostics to international demand when incentives and technical support align. (AP News)

2. Major opportunities — why now matters

a) Regulatory harmonization through AMA

A functioning AMA can dramatically lower regulatory cost and time-to-market for medical devices and IVDs by offering continental guidance, mutual recognition and technical support — unlocking pan-African scale for manufacturers and simplified procurement for governments.

b) Funding & industrial strategy

Multilateral and regional finance (AfDB, Afreximbank, private partners) are shifting from project grants to industrial financing, enabling larger capital investments (factories, cold-chains, fill/finish facilities) and de-risking private investments. This is the capital needed to move from small pilot plants to reliable commercial scale.

c) Regional markets & AfCFTA

The African Continental Free Trade Area (AfCFTA) offers the prospect of large integrated regional markets. Scale means lower unit costs and greater incentive for upstream suppliers (components, reagents, spare parts) to locate production in Africa.

d) Innovation & digital leapfrogging

Telemedicine, mobile diagnostics, point-of-care devices and AI diagnostic tools can be deployed rapidly, often at lower marginal cost than building centralized capacity. Africa can leapfrog legacy infrastructure by adopting cloud, mobile and local manufacturing simultaneously.

e) Human capital & training

Growing biomedical engineering programmes, surgical training centres and device start-ups are increasing the skilled workforce able to design, maintain and certify medical tech locally. These human assets are critical for both commercialization and safe use.

3. The stubborn challenges (and why they matter)

1) Regulatory fragmentation and slow harmonization

Although AMA exists on paper and momentum is growing, implementation across 55 AU states remains uneven. Until mutual recognition and efficient regulatory pathways exist, manufacturers face multiple submissions, duplicative testing and market fragmentation. This drives cost and delays.

2) Equipment functionality & maintenance gap

A persistent, under-reported crisis is equipment downtime and non-functionality: a large share of donated or purchased devices in low-resource settings are not operational for long periods because of missing spare parts, lack of preventative maintenance, and weak biomedical engineering capacity. Multiple studies across African hospitals highlight reactive maintenance, lack of spare parts and scarce funding for lifecycle management. This reduces return on procurement and endangers patients.

3) Supply-chain & logistics bottlenecks

Poor transport, cold-chain gaps, high import tariffs in some countries, and inconsistent customs processes add time and cost. Even where local production is possible, logistical friction undermines competitiveness. Investments in ports, freight and regional logistics are vital to make manufactured products truly competitive.

4) Capital & business model mismatch

Many local entrepreneurs face a capital gap between seed grants and industrial debt. Commercial banks view medtech manufacturing as risky and unfamiliar. Blended finance, advance purchase commitments, and public anchor procurement are needed to bridge this valley of death.

5) Standards, quality and clinical trust

Hospitals and regulators rightly demand evidence of safety and effectiveness. Building GMP/ISO/WHO-aligned quality systems takes time and upfront investment. Without them, local products struggle to win institutional tenders or export certificates. (World Health Organization)

4. Pragmatic priorities for decision-makers (what actually moves the needle)

Below are targeted, actionable interventions that ministries, procuring agencies, development banks and the private sector can pursue in 2025–2030.

1. Fast-track regulatory convergence (short term, high impact)

• Support AMA operational capacity and adopt mutual recognition for essential devices and IVDs.

• Create a continental “fast lane” for essential diagnostics and critical devices (e.g., oxygen equipment, PPE, basic imaging).

2. Invest in lifecycle management & local maintenance capacity (medium term)

• Fund regional biomedical engineering hubs (training + spare-parts pools).

• Make maintenance contracts and local training mandatory in procurement tender documents — shift from “buying equipment” to “buying uptime.” Evidence shows decentralized maintenance models can measurably improve equipment availability.

3. Use public procurement to create demand signals (short/medium term)

• Governments should create predictable offtake (advance purchase agreements) for locally manufactured diagnostics and simple devices. Predictable demand attracts manufacturers and lowers financing costs. Use pooled procurement (e.g., African Medical Supplies Platform) to aggregate buying power.

4. Scale regional finance instruments (immediate)

• Scale AfDB/Afreximbank facilities, blended finance and credit lines targeted at medtech SMEs and mid-scale plants. Encourage co-investment with manufacturers to reach bankable scale.

5. Support quality-by-design & standards uptake (medium term)

• Fund technical assistance for ISO/GMP certification, clinical evaluation and post-market surveillance. WHO guidance and technical series on medical device policies should form the baseline for capacity building. (World Health Organization)

6. Strengthen regional supply chains & logistics (longer term)

• Invest in cold-chain nodes, intra-regional corridors and customs harmonization to reduce friction and cost — logistics is often the hidden cost driver that kills competitiveness.

5. Quick wins that are affordable now

• Prioritize local production of high-impact, low-complexity items: PPE, lateral flow tests, reagent kits, oxygen delivery accessories, tubing and basic consumables. These provide rapid returns and build local quality systems. Morocco’s mpox test example shows rapid impact when effort and policy align.

• Embed service & spare parts in every tender: Make 3–5 year spare-parts and maintenance contracts a requirement. It’s a small incremental procurement cost that multiplies device uptime.

• Public-private training partnerships: Use hospitals and universities to incubate biomedical technician training linked to supplier maintenance programs.

6. Metrics that should guide policy and procurement

Decision makers must track the right KPIs (not just procurement spend):

• Equipment functionality rate (percentage of devices operational and used)

• Time to repair (mean time to repair for critical devices)

• Local procurement share (percentage of essential devices and consumables sourced locally)

• Regulatory approval time (AMA/NRAs median approval days)

• Manufacturing utilization (plant capacity utilization %)

These indicators align procurement with outcomes — uptime, safety and local economic value.

7. A call to action — a three-point pact

1. Ministries & procurers: Redesign tenders to reward local production + maintenance, and provide clear demand signals.

2. Financiers & development banks: Scale blended finance and patient capital for mid-scale manufacturing and logistics.

3. Industry & universities: Form consortia to fast-track standards, clinical validation and workforce development.

If Africa aligns these three levers — regulation, finance, and demand — the continent can transform medtech from an import bill into a jobs-creating, life-saving industrial sector.

Conclusion — honest optimism (and an open invitation)

Africa has the policy momentum, technical talent and growing market to develop a resilient medtech ecosystem. But momentum alone is insufficient. The next 3–5 years require hard, coordinated work: operationalizing AMA; embedding maintenance into procurement; scaling regional finance; and choosing the right production priorities. For leaders in government, healthcare procurement, and industry, this is a strategic moment to pivot from dependency to capability.

This article is the first in a series. Next pieces will deep-dive into (1) practical procurement reforms to embed maintenance and local content; (2) financing blueprints for mid-scale medtech plants; and (3) a technical roadmap to localize diagnostics and essential device production in East Africa.

Key sources & further reading (selected)

• AU: Treaty for the establishment of the African Medicines Agency (AMA) — entry into force. (African Union)

• WHO — Medical devices: policy, standards and local production guidance. (World Health Organization)

• Africa CDC — Partnership for Vaccine Manufacturing & local production updates. (Health Policy Watch)

• African Development Bank — investments and strategy for pharmaceutical & health manufacturing. (avmi-africa.org)

• Systematic review: Medical device regulation and oversight in African countries. (PubMed)

• Studies on medical equipment functionality and maintenance gaps (multiple country analyses). (BioMed Central)

• AP News: Morocco’s local production of mpox tests as an African example of rapid diagnostics production. (AP News)

Your informed feedback on this topic and / or related challenges and solutions will be appreciated