Guidelines for Importation and Exportation of Pharmaceutical Products and Medical Devices.

Being among the functions of the Rwanda Food and Drugs Authority, to regulate the import and export of pharmaceuticals, medical devices, and diagnostics, these guidelines provide guidance on the information and documentation required in any application submitted to Rwanda FDA by an importer or exporter of pharmaceutical products, medical devices, and diagnostics.
Adherence to the set requirements have the objective to minimize the delays in processing the applications of import and export permits. These guidelines also provide guidance to the inspectors to minimize risks of trading sub-standard products among nations.
The Guidelines are composed by 2 Modules regulating the importation of pharmaceutical products, medical devices and diagnostics (Chapter 1) and their exportation (Chapter 2). The text also provides for the review and appeal procedure available to any person aggrieved by the decision of the Authority in relation to any application for importation or exportation of devices.
The Guidelines are annexed with 6 documents concerning the Primis import approved visa, the Official Certificate of importation of controlled substances, the Import licence form, the Primis import approved licence, the Suspected poor quality product reporting form, the Export license form.