AUTHOR=Matovu Brian , Takuwa Mercy , Mpaata Charles Norman , Denison Fiona , Kiwanuka Noah , Lewis Steff , Norrie John , Ononge Sam , Muhimbise Owen , Tuck Sharon , Etuket Maureen Dimitri , Ssekitoleko Robert T. TITLE=Review of investigational medical devices' clinical trials and regulations in Africa as a benchmark for new innovations JOURNAL=Frontiers in Medical Technology VOLUME=4 YEAR=2022 URL=https://www.frontiersin.org/journals/medical-technology/articles/10.3389/fmedt.2022.952767 DOI=10.3389/fmedt.2022.952767 ISSN=2673-3129 ABSTRACT=

Medical technologies present a huge potential in improving global health playing a key role toward achieving Sustainable Development Goal 3 by 2030. A number of clinicians, innovators, business entities and biomedical engineers among others have developed a number of innovative medical devices and technologies to address the healthcare challenges especially in Africa. Globally, medical devices clinical trials present the most acceptable method for determining the risks and benefits of medical device innovations with the aim of ascertaining their effectiveness and safety as compared with established medical practice. However, there are very few medical device clinical trials reported in Africa compared to other regions like USA, UK and Europe. Most of the medical device clinical trials reported in Africa are addressing challenges around HIV/AIDS, maternal health and NCDs. In this mini review, we report about some of the published medical device clinical trials in Africa PubMed and Google Scholar and their associated challenges.