African Medical Devices Regulatory Harmonization Program

The African Medical Devices Regulatory Harmonization Program, managed by the Food and Drug Administration under the Department of Health and Human Services, aims to establish unified standards and guidelines for medical devices across the African continent. The program focuses on strengthening innovation, development, and regulation to ensure that available medical devices meet strict quality and safety requirements. By creating aligned regulatory oversight practices, the initiative seeks to prevent the distribution of substandard products that could cause adverse health outcomes or increase healthcare costs. This forecast opportunity, identified under NAICS code 926150, is coordinated by Grants Management Specialist Shashi Malhotra.