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Doc. No Title Category Last Update Download
LSD/VBT/GDL/001 Guidelines-Governing-LR_Final-draft (1).docx Guidelines 01/12/2026 Download
ODG/QMS/FMT/023-1 Providing comment on document under development process Forms 24/02/2026 Download
DD/VMDR/FMT/027-1 Cover Letter for Application of Notification of Veterinary Medical Devices and In Vitro Diagnostic Devices Forms 12/02/2026 Download
DD/VMDR/GDL/008 Guideline for Notification of Veterinary Medical Devices and In Vitro Diagnostic Devices Guidelines 12/02/2026 Download
DD/VMDR/FOM/006 Notification Application Form of Veterinary Medical devices and or In Vitro Diagnostics Devices (IVDD) Forms 12/02/2026 Download
DD/PIL/5565/FDA/2025 Circular on Public consultation and call for comments on regulatory documents Guidelines 31/12/2025 Download
DD/PIL/TRG/005-Rev_5 REGULATIONS GOVERNING THE LICENSING OF PUBLIC AND PRIVATE MANUFACTURERS, DISTRIBUTORS, WHOLESALERS AND RETAILERS OF MEDICAL PRODUCTS Regulations 18/12/2025 Download
DD/PIL/GDL/005-Rev_5 GUIDELINES FOR LICENSING OF PUBLIC AND PRIVATE MANUFACTURERS, DISTRIBUTORS, WHOLESALERS AND RETAILERS OF HUMAN MEDICINES Guidelines 18/12/2025 Download
WWW/XXX/YYY/ZZZ-HM-1 GUIDELINES FOR CHANGE TO REGISTERED OR NOTIFIED MEDICAL DEVICES Guidelines 17/12/2025 Download
DAR/GDL/075-Version-3 GUIDELINES FOR REGISTRATION OF IN VITRO DIAGNOSTICS DEVICES Guidelines 17/12/2025 Download
DHT/GDL/024-Version-2 GUIDELINES FOR REGISTRATION OF MEDICAL DEVICES Guidelines 17/12/2025 Download
WWW/XXX/YYY/ZZZ-HM-2 GUIDELINES FOR REVIEW AND APPROVAL OF SOFTWARE AS MEDICAL DEVICES (SaMD) Guidelines 17/12/2025 Download
DD/PVCT/GDL/008-V4 Guidelines for Review and Approval of Clinical Trials Guidelines 21/08/2025 Download
DD/PVCT/GDL/005-V4 Guidelines for Clinical Trials Applications in Rwanda Guidelines 21/08/2025 Download
DD/PVCT/FOM/007 CLINICAL TRIAL APPLICATION FORM Forms 21/08/2025 Download