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.

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 to ensure your product meets all regional requirements and reaches the market smoothly and efficiently.

Our Services Include:

1. Regulatory Strategy & Market Planning

• Country-specific regulatory intelligence across Sub-Saharan and North Africa

• Product classification and applicable regulatory pathway identification

• Strategic compliance and market entry roadmap

2. Dossier Preparation & Product Registration

• Preparation of regulatory dossiers in required formats (CSDT, GHTF, national formats)

• Submission to local regulatory authorities such as:

  • SAHPRA (South Africa)

  • PPB (Kenya)

  • NDA (Uganda)

  • ZAMRA (Zambia)

  • FMHACA (Ethiopia)

  • DPM (Morocco, Tunisia)

• Support for both new product registrations and license renewals

3. Local Authorized Representative (LAR) Support

• Identifying and coordinating with compliant local agents or distributors

• Managing legal and technical obligations required for registration

4. Labeling & Packaging Compliance

• Review and alignment of labels, IFUs, and artwork to country-specific standards

• Certified translations (e.g., French, Arabic, Swahili) where applicable

5. Import Licensing & Distribution Setup

• Assistance in obtaining import permits and customs documentation

• Coordination with logistics partners and local suppliers for compliant market entry

6. Post-Market Surveillance (PMS) & Regulatory Maintenance

• Establishing PMS systems in line with local guidelines

• Adverse event reporting and field safety corrective action (FSCA) management

• Ongoing compliance updates and regulatory renewals

Key Countries We Support in Africa:

• South Africa (SAHPRA)

• Kenya (PPB)

• Nigeria (NAFDAC)

• Uganda (NDA)

• Ethiopia (EFDA/FMCHA)

• Zambia (ZAMRA)

• Tanzania (TMDA)

• Ghana (FDA Ghana)

• Morocco, Tunisia, Algeria (North Africa DPM bodies)

Why Choose RABT Global?

• Pan-African Regulatory Expertise
  Deep understanding of regulatory frameworks across Anglophone, Francophone, and Lusophone regions

• 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

Let’s Get Started

Planning to launch your medical device in Africa?
RABT Global is your regulatory partner for end-to-end compliance, from strategy to post-approval support