Experiences of medical device innovators as they navigate the regulatory system in Uganda.

Objective: A medical device must undergo rigorous regulatory processes to verify its safety and effectiveness while in use. In low-and middle-income countries like Uganda however, medical device innovators and designers face challenges around bringing a device from ideation to being market-ready. This is mainly attributed to a lack of clear regulatory procedures among other factors. In this paper, we illustrate the current landscape of investigational medical devices regulation in Uganda. Methods: Information about the different bodies involved in regulation of medical devices in Uganda was obtained online. Nine medical device teams whose devices have gone through the Ugandan regulatory system were interviewed to gain insights into their experiences with the regulatory system. Interviews focused on the challenges they faced, how they navigated them, and factors that supported their progress towards putting their devices on the market. Results: We identified different bodies that are part of the stepwise regulatory pathway of investigational medical devices in Uganda and roles played by each in the regulatory process. Experiences of the medical device teams collected showed that navigation through the regulatory system was different for each team and progress towards market readiness was fuelled by funding, simplicity of device, and mentorship. Conclusion: Medical devices regulation exists in Uganda but is characterised by a landscape that is still in development which thereby affects the progress of investigational medical devices.

Review of investigational medical devices' clinical trials and regulations in Africa as a benchmark for new innovations.

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.