Our Medical Device Registration Process in Africa
Device Classification & Regulatory Pathway Identification
- Determine device classification (Class A, B, C, or D) based on each country’s regulations.
- Identify the applicable registration pathway (national approval, reliance mechanisms, or regional harmonization).
- Develop a strategic plan for multi-country market entry.
Appointing a Local Authorized Representative
- Assist in appointing a Local Authorized Representative (LAR) as required.
- Manage regulatory communication and submission coordination with national authorities.
Technical Documentation Preparation & Submission
- Compile a technical dossier including labeling, IFU, risk analysis, and quality system compliance.
- Ensure alignment with international standards (ISO 13485, WHO, FDA, CE Marking where applicable).
- Submit documentation to relevant regulatory bodies (SAHPRA, NAFDAC, PPB, EDA, and others).
Regulatory Review & Market Approval
- Coordinate with authorities for document verification and technical assessment.
- Address queries and provide additional evidence where required.
- Obtain the necessary registration certificates, licenses, or regulatory approvals.
Post-Market Compliance & Surveillance
- Ensure adherence to post-market surveillance (PMS) and vigilance reporting.
- Assist with adverse event reporting, recalls, and corrective actions.
- Manage renewals, modifications, and compliance audits.
AFRICAN COUNTRIES: Ghana, Nigeria, Benin, Burkina Faso, Central African Republic, Congo, Egypt, Ethiopia, Gabon, Liberia, Malawi, Morocco, Rwanda, Sierra Leone, Sudan, Tanzania, Togo, Cameroon, Uganda, Kenya, South Africa.
