RWANDA
RWANDA
Rwanda is a country in East Africa. Its capital is Kigali and Kinyarwanda, English, French and Swahili are the official languages of Rwanda.
Rwanda is a member state of the Economic Community of Central African States (ECCAS)
Medicines, medical devices, food supplements, foods and cosmetics can only be imported into Rwanda after registration.
Registration of medicines:
Rwanda has its own national texts and particularities for the registration of medicines.
The registration file must be in CTD format and in English.
Authority governing drug registration: Rwanda Food and Drug Authority: https://new.rwandafda.gov.rw/
The registration of medicines is carried out according to strict regulations.
Registration of medical devices and In Vitro diagnostic devices:
Rwanda has its own national texts and particularities for the registration of medical devices.
The authority governing the registration of medical devices and In Vitro diagnostic devices: Rwanda Food and Drug Authority (Rwanda FDA): https://new.rwandafda.gov.rw/
The registration of medical devices is carried out according to strict regulations.
AREMA offers you full assistance for the registration of your Medicines, Medical devices and other health products in Rwanda.
We provide regulatory services from the feasibility study, regulatory monitoring, the preparation and translation of your files, the deposit, monitoring and registration of your various products up to the implementation of a pharmacovigilance system and post-MA monitoring.
We also offer the possibility of legal representation and marketing.
In order to initiate any collaboration or for any consultation you can contact us by email: