RWANDA FDA
Rwanda Food and Drugs Authority
STAKEHOLDERS DOCUMENTS
Published stakeholder documents — July 2026
Total: 82
Available: 82
| SN | Doc No. | Title | Category | Last Updated | File |
|---|---|---|---|---|---|
| No documents match your search. | |||||
| 1 | FDISM/FDIC/FMT/007 | 23-10-2024-Guidelines-for-Regulatory-inspection-for-processed-food-products-and-related-products.docx | Guidelines | 30/12/2022 | Download |
| 2 | FD/FSMIL/TRG/007 | 23-10-2024-_-Regulations-Governing-Regulatory-Inspections-for-Processed-food-products-and-related-products (2).docx | Regulations | 23/10/2024 | Download |
| 3 | CBD/TRG/028 | ADDENDUM TO THE REGULATION NO.: CBD/TRG/028 GOVERNING LICENSING TO MANUFACTURE, TO STORE, TO OPERATE AS WHOLESALE AND RETAIL SELLER OF PROCESSED FOODS AND RELATED PRODUCTS | Regulations | 21/08/2025 | Download |
| 4 | 111-2026 | ALCOHOLIC BEVERAGES REGULATIONS IN RWANDA | Regulations | 30/06/2026 | Download |
| 5 | DPT/DIV/--V4 | CIOMS SERIOUS ADVERSE EVENTS (SAE) REPORTING FORM | Forms | 21/08/2025 | Download |
| 6 | FDISM/PVSM/500 | Circular on call for comments on Reviewed Clinical Trial Technical Documents | Circular | 03/02/2023 | Download |
| 7 | DD/PIL/5565/FDA/2025 | Circular on Public consultation and call for comments on regulatory documents | Guidelines | 31/12/2025 | Download |
| 8 | DFAR/VMDAR/1101 | Circular on public consultation and call for comments on veterinary products regulatory documents | Circular | 14/03/2023 | Download |
| 9 | FDISM/FBIC/1267 | Circular-on-public-consultation-and-call-for-comments-on-regulatory-documents | Circular | 14/03/2024 | Download |
| 10 | DD/PVCT/FOM/007 | CLINICAL TRIAL APPLICATION FORM | Forms | 21/08/2025 | Download |
| 11 | DPT/DIV/-V4 | Clinical Trial Causality Assessment Report | Forms | 21/08/2025 | Download |
| 12 | DD/PVCT/FMT/037 | CLINICAL TRIAL PROTOCOL | Forms | 21/08/2025 | Download |
| 13 | 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 |
| 14 | DD/PVCT/FOM/034 | DECLARATION BY PI OR CO-PI | Forms | 21/08/2025 | Download |
| 15 | 02-V4 | Draft-Guidelines-for-Conducting-Veterinary-Pesticides-Field-Trials (1).docx | Guidelines | 02/10/2023 | Download |
| 16 | 03-V2 | Draft-Guidelines-on-Specific-Efficacy-Trials-Requirements-for-Ectoparasiticides-on-Cattle-in-the-EAC.docx | Guidelines | 20/09/2023 | Download |
| 17 | 002-V4 | Draft-Veterinary-pesticide-Good-Manufacturing-Practice-inspection-guidelines-Annex.docx | Guidelines | 01/08/2025 | Download |
| 18 | DIS/GDL/002 | GMP_GUIDLINE_FOR_FOOD_04_AUGUST_2022 | Guidelines | 21/06/2022 | Download |
| 19 | DD/PVCT/ GDL/ | Guidance for Therapeutic or Vaccine Clinical Trial Application Evaluation During Public Health Emergency | Guidelines | 21/08/2025 | Download |
| 20 | DD/PVCT/ GDL | Guidance for Therapeutic or Vaccine Clinical Trial Application Evaluation During Public Health Emergency 2 | Guidelines | 21/08/2025 | Download |
| 21 | DD/VMDR/GDL/008 | Guideline for Notification of Veterinary Medical Devices and In Vitro Diagnostic Devices | Guidelines | 12/02/2026 | Download |
| 22 | WWW/XXX/YYY/ZZZ-HM-1 | GUIDELINES FOR CHANGE TO REGISTERED OR NOTIFIED MEDICAL DEVICES | Guidelines | 17/12/2025 | Download |
| 23 | DD/PVCT/GDL/005 | Guidelines for Clinical Trials Applications in Rwanda | Guidelines | 21/08/2025 | Download |
| 24 | DD/PVCT/GDL/005-V4 | Guidelines for Clinical Trials Applications in Rwanda | Guidelines | 21/08/2025 | Download |
| 25 | DD/PIL/GDL/012 | GUIDELINES FOR GOOD MANUFACTURING PRACTICES INSPECTIONS FOR PHARMACEUTICAL PRODUCTS MANUFACTURING FACILITIES | Guidelines | 18/06/2026 | Download |
| 26 | FDISM/FDIEC/GDL/002 | GUIDELINES FOR IMPORTATION AND EXPORTATION OF FOOD PRODUCTS | Guidelines | 01/01/2022 | Download |
| 27 | DD/DIEC/GDL/002 | GUIDELINES FOR IMPORTATION AND EXPORTATION OF MEDICAL DEVICES INCLUDING IN-VITRO DIAGNOSTICS | Guidelines | 13/04/2026 | Download |
| 28 | DD/DIEC/GDL/001 | GUIDELINES FOR IMPORTATION AND EXPORTATION OF PHARMACEUTICAL PRODUCTS | Guidelines | 13/04/2026 | Download |
| 29 | FDISM/FDIEC/GDL/001 | GUIDELINES FOR IMPORTATION AND EXPORTATION OF PHARMACEUTICAL PRODUCTS AND MEDICAL DEVICES | Guidelines | 01/10/2022 | Download |
| 30 | FDISM/FDIEC/GDL/004 | GUIDELINES FOR IMPORTATION AND EXPORTATION OF TOBACCO AND TOBACCO PRODUCTS | Guidelines | 01/01/2022 | Download |
| 31 | 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 |
| 32 | DD/PVCT/GDL/013 | Guidelines for Monitoring and Reporting Clinical Trial Safety Data in Rwanda | Guidelines | 21/08/2025 | Download |
| 33 | DD/PVCT/GDL/006 | GUIDELINES FOR RECALL, TREATMENT AND DISPOSAL OF SUBSTANDARD AND FALSIFIED PHARMACEUTICAL PRODUCTS AND MEDICAL DEVICES INCLUDING IN-VITRO DIAGNOSTICS (IVDS) | Guidelines | 23/07/2026 | Download |
| 34 | DHT/GDL/024-Version-2 | GUIDELINES FOR REGISTRATION OF MEDICAL DEVICES | Guidelines | 17/12/2025 | Download |
| 35 | FD/FRIC/GDL/002 | GUIDELINES FOR REGISTRATION OF FOOD SUPPLEMENTS | Guidelines | 01/06/2024 | Download |
| 36 | DAR/GDL/075-Version-3 | GUIDELINES FOR REGISTRATION OF IN VITRO DIAGNOSTICS DEVICES | Guidelines | 17/12/2025 | Download |
| 37 | WWW/XXX/YYY/ZZZ | Guidelines for Registration of Innovative Human Medical Products | Guidelines | 05/06/2025 | Download |
| 38 | FD/FRIC/GDL/001 | GUIDELINES FOR REGISTRATION OF PROCESSED FOODS | Guidelines | 01/06/2024 | Download |
| 39 | DD/VMDR/GDL/004-V2 | GUIDELINES FOR REGISTRATION OF VETERINARY BIOLOGICAL PRODUCTS | Guidelines | 06/02/2025 | Download |
| 40 | DD/VMDR/GDL/001-V2 | GUIDELINES FOR REGISTRATION OF VETERINARY PHARMACEUTICAL PRODUCTS | Guidelines | 06/02/2025 | Download |
| 41 | DD/PVCT/GDL/008 | Guidelines for Review and Approval of Clinical Trials | Guidelines | 21/08/2025 | Download |
| 42 | DD/PVCT/GDL/008-V4 | Guidelines for Review and Approval of Clinical Trials | Guidelines | 21/08/2025 | Download |
| 43 | WWW/XXX/YYY/ZZZ-HM-2 | GUIDELINES FOR REVIEW AND APPROVAL OF SOFTWARE AS MEDICAL DEVICES (SaMD) | Guidelines | 17/12/2025 | Download |
| 44 | 001-V4 | GUIDELINES FOR SUBMISSION OF DOCUMENTATION FOR REGISTRATION OF LABORATORY CHEMICALS | Guidelines | 01/08/2022 | Download |
| 45 | 002-1 | GUIDELINES GOVERNING THE USE AND DISTRIBUTION OF ETHYL ALCOHOL IN RWANDA | Regulations | 21/04/2026 | Download |
| 46 | FDISM/FDIEC/GDL/005 | Guidelines on control of importation and exportation of medicated cosmetic products | Guidelines | 01/01/2022 | Download |
| 47 | DD/CHCR/GDL/002 | GUIDELINES ON SUBMISSION OF DOCUMENTATION FOR REGISTRATION OF COSMETIC PRODUCTS | Guidelines | 01/08/2025 | Download |
| 48 | DAR/GDL/075 | Guidelines On Submission Of Documentation For Registration Of In Vitro Diagnostics Devices | Guidelines | 16/06/2022 | Download |
| 49 | DHT/GDL/024 | GUIDELINES ON SUBMISSION OF DOCUMENTATION FOR REGISTRATION OF MEDICAL DEVICES | Guidelines | 01/12/2023 | Download |
| 50 | DD/CHCR/GDL/003 | GUIDELINES ON SUBMISSION OF DOCUMENTATION FOR REGISTRATION OF PUBLIC HEALTH ANTISEPTIC AND DISINFECTANT PRODUCTS | Guidelines | 01/08/2025 | Download |
| 51 | DD/CHCR/GDL/005 | GUIDELINES ON SUBMISSION OF DOCUMENTATION FOR REGISTRATION OF PUBLIC HEALTH LABORATORY CHEMICALS | Guidelines | 29/11/2022 | Download |
| 52 | DD/CHCR/GDL/001 | GUIDELINES ON SUBMISSION OF DOCUMENTATION FOR REGISTRATION OF VECTOR CONTROL PRODUCTS AUGUST, 2025 | Guidelines | 01/08/2025 | Download |
| 53 | DD/CHCR/GDL/006 | GUIDELINES ON VARIATION APPLICATION OF REGISTERED COSMETICS, VECTOR CONTROL AND PUBLIC HEALTH LABORATORY CHEMICAL PRODUCTS | Guidelines | 01/08/2025 | Download |
| 54 | DIS/FOM/095 | Guidelines-for-Post-Market-Surveillance.docx | Guidelines | 20/07/2021 | Download |
| 55 | DAR/GDL/068 | Intarnally_validated_Guidelines_on_submission_for_documentation_of_registration_of_cleaning_chemicals.doc | Guidelines | 01/01/2022 | Download |
| 56 | DD/PVCT/FMT/038 | INVESTIGATIONAL PRODUCT QUALITY OVERALL SUMMARY | Forms | 21/08/2025 | Download |
| 57 | DD/PVCT/FOM/033 | JOINT DECLARATION FOR SUFFICIENT FUNDS | Forms | 21/08/2025 | Download |
| 58 | DD/VMDR/FOM/006 | Notification Application Form of Veterinary Medical devices and or In Vitro Diagnostics Devices (IVDD) | Forms | 12/02/2026 | Download |
| 59 | DD/PIL//6134 | Prohibition-of-dispensing-specified-medicines-without-medical-prescription | Stakeholder-Notice | 16/12/2024 | Download |
| 60 | DD/PIL/5883 | prohibition-to-sell-medical-products-to-unauthorized-retailers | Stakeholder-Notice | 13/12/2024 | Download |
| 61 | ODG/QMS/FMT/023-1 | Providing comment on document under development process | Forms | 24/02/2026 | Download |
| 62 | ODG/QMS/FMT/023 | Providing comment on document under development process | Forms | 14/10/2022 | Download |
| 63 | 002 | REGULATIONS GOVERNING CONTROL OF ETHYL ALCOHOL FOR INDUSTRIAL, MEDICAL, LABORATORY AND COSMETIC USE IN RWANDA | Regulations | 21/04/2026 | Download |
| 64 | FDISM/FDIEC/TRG/003 | Regulations Governing Control of Importation and Exportation of Food Products | Regulations | 01/01/2022 | Download |
| 65 | DD/DIEC/TRG/001 | REGULATIONS GOVERNING CONTROL OF IMPORTATION AND EXPORTATION OF PHARMACEUTICAL PRODUCTS AND MEDICAL DEVICES | Regulations | 13/04/2026 | Download |
| 66 | FD/FRIC/TRG/001 | Regulations Governing Food Fortification Doc. No.: | Regulations | 14/01/2020 | Download |
| 67 | DD/PVCT/TRG/005 | REGULATIONS GOVERNING RECALL, TREATMENT AND DISPOSAL OF SUBSTANDARD AND FALSIFIED PHARMACEUTICAL PRODUCTS AND MEDICAL DEVICES INCLUDING IN-VITRO DIAGNOSTICS (IVDS) | Regulations | 23/07/2026 | Download |
| 68 | DD/PVCT/TRG/001-V4 | REGULATIONS GOVERNING THE CONDUCT AND INSPECTION OF CLINICAL TRIALS IN RWANDA | Guidelines | 01/08/2025 | Download |
| 69 | DD/PVCT/TRG/001 | Regulations Governing the Conduct and Inspection of Clinical Trials in Rwanda | Regulations | 21/08/2025 | Download |
| 70 | FD/TRG/003-V4 | REGULATIONS GOVERNING THE CONTROL OF PROCESSED FOOD PRODUCTS | Regulations | 21/08/2025 | Download |
| 71 | DD/PIL/TRG/005 | REGULATIONS GOVERNING THE GOOD MANUFACTURING PRACTICES OF MEDICAL PRODUCTS | Regulations | 18/06/2026 | Download |
| 72 | 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 |
| 73 | FD/TRG/007 | Regulations-for-Processed-food-products | Regulations | 06/02/2025 | Download |
| 74 | LSD/VBT/TRG/001 | Regulations-Governing-LR_Final-version .pdf | Regulations | 14/10/2022 | Download |
| 75 | FDISM/FDIEC/TRG/001 | Regulation_Governing_control_of_import_export_of_pharmaceutical_products_medical_devices-Rev2-_draft_for_validation_October_2022.docx | Regulations | 01/01/2019 | Download |
| 76 | WWW/XXX/YYY/ZZZ-- | REGULATORY GUIDANCE ON THE CONDUCT OF JOINT ENFORCEMENT INSPECTIONS ON FOOD AND BEVERAGE PRODUCTS | Regulations | 01/04/2024 | Download |
| 77 | FD/FRIC/CKL/007 | Requirements-of-Test-Parameters-for-Processed-Food-Registration_ | Requirements | 01/06/2024 | Download |
| 78 | 004-V4 | Rwanda_FDA_draft_-_Business_Plan_for_Financial_Sustainability_1st_April_2022 | Business-Plan | 01/07/2021 | Download |
| 79 | DPT/DIV/DOC.TYPE/XXX | SERIOUS ADVERSE EVENTS (SAE) REPORTING FORM | Forms | 01/08/2025 | Download |
| 80 | FDISM/FDIC/1133 | STAKEHOLDERS-NOTICE | Stakeholder-Notice | 03/03/2023 | Download |
| 81 | DD/PIL/635 | Temporary-suspension-of-opening-new-Retail-Pharmacies. | Stakeholder-Notice | 16/12/2024 | Download |
| 82 | Testing | Test Doc | Guidance | 08/07/2026 | Download |
Last updated: 28 Jul 2026, 03:02 PM