African Medical Devices Regulatory Harmonization Program
This program aims to standardize medical device regulations across Africa to improve quality, safety, and access to essential healthcare technology.
Funder: Food and Drug Administration
Due Dates: Forecasted — estimated dates not yet announced
Funding Amounts: Not specified; cooperative agreement, award ceiling/floor TBD
Summary: Supports harmonization of medical device regulations across Africa to improve quality, safety, and access to essential healthcare technology.
Key Information: This is a forecasted, sole source opportunity; eligibility is highly restricted.
Description
This program aims to enable harmonized approaches, standards, and guidelines for the regulation of medical devices across the African continent. The goal is to strengthen innovation, development, regulatory oversight, and the availability of medical devices that meet quality and safety requirements. By aligning regulatory practices, the program seeks to prevent the use or export of substandard products, reduce health risks, and avoid unnecessary healthcare expenditures.
