Dr. Emil Ivan Mwikarago

Position: Department of Human Medicine and Device assessment & Registration, Division of Human Medicine, Assessment and Registration - Rwanda FDA 
Categories: MedDev Speakers 2023

My professional experience spans over a decade, during which I have held Technical and Management Positions. Notably, I served as the National Reference Laboratory Division Manager at Rwanda Biomedical Center, where I held senior positions. In this role, I was responsible for overseeing diagnostics and management of reference laboratory division and medical device performance evaluation procedures, providing technical reports to the Ministry of Health, and guiding diagnostic algorithm decisions for equipment and IVDs in the country. My areas of expertise include Research, Training, Mentorship, supervision, diagnostics, Field epidemiology, and public health mostly touching the big three diseases such as HIV, TB, Malaria and other blood borne pathogens including regulatory procedure for medical devices per world health organization guidelines. I have published scholarly articles on these topics with over 35 Publications in PubMed and Medline and google scholar.

In June 2021, I joined Rwanda Food and Drugs Authority as the Medical Device and IVDs Assessment and Registration Analyst. In this role, I’m responsible for various tasks, registering medical devices and IVDs, developing and validating regulations, guidelines, and SOPs for full assessment, abridged, reliance, and recognition pathways, including developing strategies to quickly register devices on market in Rwanda. Additionally, I actively participate in various technical committees, including the clinical trial safety committee, Peer review committee for cosmetics and household chemicals, and the committee for good manufacturing practice at Rwanda FDA.