Understanding Medical Device Registration in Rwanda
Updated On: 24/01/2024
Regulatory Authority: Rwanda FDA
Rwanda Food and Drugs Authority hereafter 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:
Link for Regulatory Authority: https://rwandafda.gov.rw/
Local Regulation:
Classification:
Listing or Registration Requirements:
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.
Documents Required for Registration:
Registration Timeline:
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.
License Validity: 5 years
Special Labelling Requirements:Labelling should be done in English.
Requirements to import medical devices: Import License
Who should make this communication:
When to make this communication: Before placing a medical device into the market.
How OMC Medical can assist you with the process
Act as your Authorized representative
Why Choose Us
Contact us for free consultation: [email protected]
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.