Africa Markets

Complete SAHPRA regulatory compliance solutions for medical devices and healthcare products.

• SAHPRA Medical Device Registration
• Product Classification and Assessment
• Quality Management System Review
• Post-market Surveillance Compliance

Comprehensive EDA regulatory pathways for medical device market authorization.

• EDA Product Registration
• Technical Documentation Preparation
• Local Testing Requirements
• Import License Applications

End-to-end NAFDAC regulatory services for Nigerian market entry and compliance.

• NAFDAC Product Registration
• Import Permit Applications
• Good Distribution Practice
• Market Authorization Services

Complete regulatory services for medical device registration in Kenya.

• PPB Product Registration
• Medical Device Import License
• Quality System Documentation
• East African Community Compliance

Regulatory pathway for medical devices entering the Moroccan market.

• DMP Product Registration
• Technical File Assessment
• Import Authorization
• Market Surveillance Support

Complete medical device registration services for Algerian market.

• DPM Product Registration
• Import License Applications
• Local Representation Services
• Customs Clearance Support

Regulatory compliance services for medical devices in Ethiopia.

• FMHACA Product Registration
• Import Permit Applications
• Product Quality Assessment
• Market Authorization Support

Complete regulatory pathway for medical devices in Ghana.

• FDA Ghana Registration
• Import License Applications
• Product Listing Services
• Market Compliance Monitoring

Regulatory services for medical device market entry in Tanzania.

• TMDA Product Registration
• Import License Applications
• East African Community Compliance
• Distribution Channel Setup