One of the key objectives of the African Medical Devices Forum (AMDF) is building the technical
capacity of national regulatory agencies (NRAs) in medical devices and in-vitro diagnostics
regulatory frameworks through the development of technical guidance documents. The AMDF
has developed and published Guidelines on regulatory requirements for issuance of market
authorization of medical devices including in-vitro diagnostic medical devices; Guidelines for
registration of medical devices establishments; Guidelines on import and export of medical
devices including in-vitro diagnostic medical devices; and Guidelines for inspection of
manufacturing site(s) for assessment of the quality management system of medical devices
based on ISO 13485:2016.
Advancements in health technologies call for continuous considerations to carry forward and
strengthen regulatory systems, and it is important to remain cognizant of areas with specific
considerations, such as medical devices for maternal, newborn, and child subpopulations. In view
of that, the AMDF, with the support of the US Agency for International Development (USAID)
Medicines, Technologies, and Pharmaceutical Services (MTaPS) Program implemented by
Management Sciences for Health, has developed this document entitled Specific Considerations
for Regulating Maternal, Newborn, and Child Health Medical Devices – Market Authorization. It
outlines specificities when assessing these medical devices at the market authorization phase. It
is to be used with the other guidance documents that the AMDF has developed on market
authorization for medical devices, including in-vitro diagnostic (IVD) medical devices.
The AMDF considers this document a key resource that will provide information to NRAs in
advancing regulatory system strengthening in Africa.
