Rwanda FDA
Rwanda Food and Drugs Authority here after designated as the “Authority,” was established by the law No 003/2018 of 09/02/2018 determining its mission, organization, and functioning.
The mandate of the Authority is to protect public health through regulation of human and veterinary medicines, vaccines and other biological products, processed foods, poisons, medicated cosmetics, medical devices, household chemical substances, tobacco, and tobacco products.
The conduct and performance of the Authority is underpinned by the following five core values:
An application consists of online or hard copies submission. The application for registration of medical devices is only received by the Authority when the payment of prescribed registration fees is affected.
After receiving a product registration application, a reference number is assigned to the application, and it will be used in all subsequent correspondences relating to the application. An acknowledged receipt will be issued.
Medical device dossiers shall be scheduled for assessment according to the First in First out (FIFO) basis upon compliance of the requirements. A new application shall be processed within nine (9) months of receipt of the application.
The applicant will be required to provide any requested additional data within ninety (90) calendar days. Additional data or query responses shall be processed within sixty (60) calendar days.
5 years
Labelling should be done in English.
Before placing a medical device into the market.
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Our team will be happy to respond your queries. Contact us directly with your questions or for scheduling FREE consultation and we’ll be in touch as soon as possible.
Our team will be happy to respond your queries. Contact us directly with your questions or for scheduling FREE consultation and we’ll be in touch as soon as possible.
Our team will be happy to respond your queries. Contact us directly with your questions or for scheduling FREE consultation and we’ll be in touch as soon as possible.
To launch a medical device in a country, medical devices must comply with the local country’s regulatory requirements. Let us be your trusted partner in bringing your medical devices to the Global market. Contact us today to learn more about how we can assist you in every step of the way.