TY - JOUR T1 - The Evolving Landscape of Medical Device Regulation in East, Central, and Southern Africa JF - Global Health: Science and Practice JO - GLOB HEALTH SCI PRACT SP - 136 LP - 148 DO - 10.9745/GHSP-D-20-00578 VL - 9 IS - 1 AU - Sarah Hubner AU - Caroline Maloney AU - Sarah Dunn Phillips AU - Pratik Doshi AU - Julius Mugaga AU - Robert Tamale Ssekitoleko AU - Jenna L. Mueller AU - Tamara N. Fitzgerald Y1 - 2021/03/31 UR - http://www.ghspjournal.org/content/9/1/136.abstract N2 - Key FindingsAlthough 11 of 14 member countries of the College of Surgeons of East, Central, and Southern Africa have legislation mandating the regulation of medical devices, only half are currently developing medical device regulatory processes and half do not have a formal process.A country's gross domestic product had a strong correlation to level of medical device regulation.The number of years that had elapsed from the country's independence to the present had a strong correlation to the status of the country's regulatory processes.Key ImplicationsTo expand regulatory capacity and minimize resource expenditure when developing or creating new medical device regulations, policy makers should facilitate adopting or amending existing harmonized regulations.Ministries of health should prioritize local capacity building in the form of well-trained personnel, tools, and facilities to improve regulatory standards.Medical technology companies with a charitable division should consider investment in capacity building and innovation to harmonize regulatory standards across African countries.Effective regulatory frameworks, harmonized to international standards, are critical to expanding access to quality medical devices in low- and middle-income countries. This review provides a summary of the state of medical device regulation in the 14 member countries of the College of Surgeons of East, Central, and Southern Africa (COSECSA) and South Africa. Countries were categorized according to level of regulatory establishment, which was found to be positively correlated to gross domestic product (GDP; rs=0.90) and years of freedom from colonization (rs=0.60), and less positively correlated to GDP per capita (rs=0.40). Although most countries mandate medical device regulation in national legislation, few employ all the guidelines set forth by the World Health Organization. A streamlined regulatory process across African nations would simplify this process for innovators seeking to bring medical devices to the African market, thereby increasing patient access to safe medical devices. ER -