Expand into African Markets with
Trusted Regulatory Support
Africa’s medical device sector is gaining momentum with rising healthcare demands, growing investments, and evolving regulatory systems across the continent. However, navigating the diverse regulatory landscapes in African countries can be complex without local expertise.
🌍 Key Countries We Support in Africa
PPB (Kenya) — NDA (Uganda)
NAFDAC (Nigeria) — FDA Ghana
EFDA/FMCHA (Ethiopia) — ZAMRA (Zambia)
Morocco, Tunisia, Algeria — DPM Bodies
End-to-End Regulatory Services Across Africa
At RABT Global, we provide end-to-end Regulatory Services for Medical Devices across key African markets. Our experienced team works closely with regulatory bodies, local agents, and compliance stakeholders.
🇳🇬 Nigeria
🇺🇬 Uganda
🇪🇹 Ethiopia
🇿🇲 Zambia
🇹🇿 Tanzania
🇬🇭 Ghana
🇲🇦 North Africa
🤝 Our Commitment: RABT Global is your regulatory partner for end-to-end compliance, from strategy to post-approval support across key African markets.
Your Trusted Regulatory Partner in Africa
Trusted Local Network — Established relationships with local agents and regulatory consultants
Accelerated Approvals — Efficient registration processes that reduce delays and improve time-to-market
Compliance-Driven Approach — Adherence to global standards and regional authority requirements
Our Services Include
Our experienced team works closely with regulatory bodies, local agents, and compliance stakeholders to ensure your product meets all regional requirements and reaches the market smoothly and efficiently.
Regulatory Strategy & Market Planning
Product classification and applicable regulatory pathway identification. Strategic compliance and market entry roadmap.
Strategy
Dossier Preparation & Product Registration
Submission to local regulatory authorities — PPB (Kenya), NDA (Uganda), ZAMRA (Zambia), FMHACA (Ethiopia), DPM (Morocco, Tunisia). Support for both new product registrations and license renewals.
Registration
Local Authorized Representative (LAR) Support
Managing legal and technical obligations required for registration.
LAR Services
Labeling & Packaging Compliance
Certified translations (e.g., French, Arabic, Swahili) where applicable.
Labeling
Import Licensing & Distribution Setup
Coordination with logistics partners and local suppliers for compliant market entry.
Import & Distribution
Post-Market Surveillance (PMS) & Regulatory Maintenance
Adverse event reporting and field safety corrective action (FSCA) management. Ongoing compliance updates and regulatory renewals.
Post-Market
Regulatory Submissions Across Africa
Key countries we support in Africa.
East & West Africa
Kenya, Uganda, Nigeria, Ethiopia, Zambia, Tanzania, Ghana
Kenya — PPB
Nigeria — NAFDAC
Uganda — NDA
Ethiopia — EFDA/FMCHA
Zambia — ZAMRA
Tanzania — TMDA
Ghana — FDA Ghana
North Africa
Morocco, Tunisia, Algeria
Morocco — DPM
Tunisia — DPM
Algeria — North Africa DPM bodies