African Medical Devices Regulatory Harmonization Program

The African Medical Devices Regulatory Harmonization Program aims to establish unified standards, guidelines, and practices across the African continent to improve the innovation, development, regulation, and accessibility of medical devices that meet stringent quality and safety benchmarks. By fostering collaborative regulatory frameworks, the initiative seeks to eliminate inconsistencies in oversight, prevent the circulation and export of substandard medical products, and reduce associated health risks and financial burdens on healthcare systems. This program is designed to build capacity and ensure alignment among African regulatory authorities, promoting public health through reliable and effective medical technologies. The program is forecasted by the U.S. Food and Drug Administration under the Department of Health and Human Services, with no specific solicitation number assigned at this time. The initiative is not tied to a particular set-aside category or NAICS code, and its implementation is focused on continental impact rather than localized performance. Interested parties can reach out to Shashi Malhotra, Grants Management Specialist, via email at shashi.malhotra@fda.hhs.gov or by phone at 240-402-7592 for further information regarding potential opportunities or program details. The official notice is accessible through the Grants.gov portal linked to the program.