Rwanda FDA Approves IMPALA Use

Last week, we received the official certificate from the Rwanda Food and Drug Administration (RFDA) approving the IMPALA system for commercial use in Rwanda! This is amazing news! While we have been busy in Rwanda for a while, we could only work from a research perspective. With the RFDA approval however, we can now market and implement the IMPALA system freely allowing us to scale up in Rwanda. The official RFDA approval has impact beyond just Rwanda though. The RFDA is a credible authority in assessing medical devices, and they are actively pursuing maturity level 3 (ML3) for regulatory authorities by the WHO, a level only few African authorities have reached so far. This means that with this certificate, IMPALA has quite literally received the stamp of approval that signals to surrounding countries the legitimacy of the IMPALA system. As we grow and expand, pointing to the Rwanda FDA approval will go a long way to fast-tracking the approval process in other countries.

Getting official approval has had its obstacles along the way.  But going through the process and receiving and implementing the feedback from the RFDA has only strengthened the IMPALA system, making it better than ever. We are thankful to the RFDA for their support during the process. We are so proud of our team, and everyone involved in the IMPALA project for all the work it took to make this happen. Now let’s see IMPALA help save lives across Rwanda!