Rwanda FDA Traceability Compliant Track And Trace System
The Rwanda Food and Drugs Authority (Rwanda FDA), the national regulator for medicines, food, and health products in the Republic of Rwanda, has mandated pharmaceutical track and trace requirements as part of its commitment to patient safety, counterfeit prevention, and alignment with the East African Community (EAC) medicines regulation harmonization initiative. The regulation requires every pharmaceutical product manufactured in or imported into Rwanda to carry a unique GS1 DataMatrix code encoding GTIN, serial number, batch number, and expiry date, with product movement data reported to Rwanda FDA's national traceability platform. Sun Teknovation's Online Track & Trace system is fully equipped to meet Rwanda FDA traceability requirements, enabling pharmaceutical manufacturers and importers to generate unique serialized codes, verify printed codes in real-time, manage multi-level aggregation, and report all product data directly to the Rwanda FDA platform. Our system ensures end-to-end compliance, helping you avoid import rejections, regulatory penalties, and market disruptions while maintaining seamless product flow into the Rwandan market.
Rwanda FDA Traceability Compliance Features
GS1 DataMatrix Code Printing (2 Side Print)
OCR / OCV Verification for Rwanda FDA Serialized Codes
PLC Controlled Machine Operation
Rwanda FDA & EAC Harmonization Compliant
Complete Validation Documentation (IQ, OQ, PQ)
Line Level Serialization with Rwanda FDA Platform Integration
Air Based Rejection for Non-Compliant Packs
Rwanda FDA Traceability Compliance Benefits
Inbuilt Server with Rwanda FDA Platform Connectivity
Compact Design for Easy Integration into Production & Export Lines
Auto-Adjustment for Multiple Carton Sizes
End-to-End Serialization with GTIN, Batch, Expiry & Serial Number
Anti-Counterfeit Verification & Patient Safety Assurance
Multi-Level Aggregation (Unit to Pallet)
Multiple Sensors for Precise Workflow
