Active MARKETS🇳🇬 Nigeria🇰🇪 Kenya🇿🇦 South Africa🇪🇬 Egypt🇪🇹 Ethiopia🇧🇼 Botswana
How It Works
Getting your device registered across multiple African markets can mean navigating different regulatory authorities, documentation standards, and local requirements in each country. Lepaz Africa coordinates the full process on your behalf — across all target markets, through a single dedicated contact.
Scoping
We map your device, target markets, and timeline to identify the most appropriate regulatory pathway for each country.
Coordination
We remain your single point of contact while coordinating with our in-country regulatory specialists from our partner network.
Execution
We drive submissions forward, manage communication between all parties, and keep you updated at every stage.
Sustained access
Registration is the beginning. We stay engaged for renewals, post-market obligations, and expansion as your needs grow.
About Lepaz Africa
Lepaz Africa BV is a Dutch-registered market access and regulatory strategy firm. We were founded with one purpose: to remove the barriers that stop quality medical technology from reaching patients on the African continent.
Africa’s healthcare market is growing fast, and its regulatory landscape is evolving rapidly. Each country operates its own system, its own timelines, and its own requirements — at different stages of regulatory maturity. Navigating that without local knowledge is slow and risky. We remove that complexity.
Our model is simple: we act as your central hub, remaining your single point of contact and coordinating a network of trusted in-country experts across six markets.
Regulatory expertise across six markets
We work across Nigeria, Kenya, South Africa, Egypt, Ethiopia, and Botswana — each with its own authority, timelines, and requirements. Our network of in-country specialists is already in place.
Commercial clarity
Beyond registration, we help manufacturers understand how to sequence markets, position products, and build a commercially sustainable African presence.
Regulatory intelligence
We monitor regulatory developments, track harmonisation progress, and help clients position ahead of changes — so market access decisions are made on current information.
Services
Lepaz Africa combines regulatory expertise with practical execution — supporting manufacturers from first registration through to sustained market presence.
01
Country-specific registration plans, documentation preparation, and dossier compilation. We leverage reliance pathways (CE, FDA, PMDA, Health Canada, among others), where available, to accelerate approvals and leverage harmonisation frameworks for multi-market efficiencies.
Multi-country filingReliance pathwaysEAC harmonisationClassification guidance
02
We map your product against African market realities — identifying the right entry sequence, institutional and private sector opportunities, and go-to-market positioning tailored to each country’s healthcare infrastructure.
Market prioritisationSector mappingPricing strategyCompetitive analysis
03
We engage, coordinate, and manage vetted in-country regulatory specialists, authorised representatives, and local agents across our active markets. Lepaz Africa remains your single point of contact throughout.
Local representationSpecialist coordinationMilestone reportingOngoing oversight
04
We monitor regulatory developments across our active markets, engage with relevant stakeholders, and identify opportunities to support capacity building that can contribute to stronger and more predictable regulatory environments.
Regulatory intelligenceCapacity buildingPolicy monitoringHarmonisation tracking
Markets
Lepaz Africa coordinates a network of vetted regulatory specialists across six active African markets. Each market operates its own regulatory system, requirements, and timelines, but you work through one structured, accountable contact.
🇳🇬 Nigeria (NAFDAC)🇰🇪 Kenya (PPB)🇿🇦 South Africa (SAHPRA)🇪🇬 Egypt (EDA)🇪🇹 Ethiopia (EFDA)🇧🇼 Botswana (BoMRA)
From market entry strategy and regulatory planning to local representation and submission management, we coordinate country-specific expertise through a single, structured approach — helping manufacturers avoid the delays and coordination failures that come with managing multiple consultants across multiple markets.
Expanding network
🇲🇦 Morocco (in development)🇩🇿 Algeria (in development)Francophone Africa (expanding coverage)
$4.73BCurrent African MedTech market — projected to reach $7.79–10B by 2032–2035, driven by rising chronic disease burden and expanding healthcare infrastructure.
90%+Of advanced medical devices are imported. Every African market has its own regulatory authority, requirements, and timelines. Coordinated market access is essential.
3–5 yrsWindow for first-movers — AU harmonisation and the African Medicines Agency are strengthening the regulatory environment. Those who enter now establish advantage before the market matures.
Why Lepaz Africa
01
You have one point of contact — regardless of how many countries you are entering. We manage the in-country network on your behalf so you never have to coordinate multiple consultants across different markets.
02
We understand international regulatory standards and how African national systems work in practice. That combination — knowing how to apply international reliance pathways within specific African requirements — is not easy to find.
03
We have done the groundwork. Experienced regulatory specialists are already in place across all six of our active markets, with direct knowledge of local requirements, processes, and authorities.
04
Whether you are making your first entry into a single African market or expanding across several, our model scales to fit — without requiring a large internal team on your side.
05
Registration opens the door. We stay involved beyond approval, supporting renewals, post-market obligations, and market expansion as your presence grows.
06
We run projects with clear timelines, regular updates, and documented progress. You always know where things stand and who is responsible for moving them forward.
Regulatory Insights
Nigeria · NAFDAC
Classification, timelines, fees, fast-track pathways, and what NAFDAC requires at each stage. With notes on CE reliance pathways and documentation standards.
Egypt · EDA
EDA’s 10-year certificate validity, CE reliance pathway, and the practical realities of dossier submission and local representation requirements.
Kenya · PPB
Kenya’s strong CE reliance framework, EAC harmonisation readiness, and how to navigate PPB’s documentation requirements and practical timelines.
Founded in The Netherlands · Specialist Medical Device Focus · Active Regulatory Network Across Six African Markets
Whether you are exploring your first African registration or planning a multi-country expansion, we start with a focused conversation about your device, your target markets, and your timeline. No obligation.
Lepaz Africa BV · The Hague, Netherlands
