History of Africa Medical Devices Forum (AMDF)

African Medical Devices Forum (AMDF) formerly known as Pan Africa Harmonization Working Party (PAHWP) was formed by medical devices regulators in Africa with the aim of improving access to safe a quality and performance of medical devices including in vitro diagnostics in Africa though harmonized regulation.

The AMDF was conceived in 2012 following stakeholder meetings in East Africa, with an interim secretariat within the East African Community under a project facilitated by the London School of Hygiene & Tropical Medicine (LSHTM) with grant funding from Grand Challenges Canada (GCC) collaborating with the Asian Harmonization Working Party AHWP and the Latin America IVD Association ALADDIV. Founding members include the East African Community Health Secretariat (EAC) and the EAC Partner States (United Republic of Tanzania, Uganda, Kenya, Rwanda and Burundi), Ethiopia, Nigeria and South Africa and the London School of Hygiene & Tropical Medicine. Partners include German International Co-operation (EAC-GIZ), the African Society for Laboratory Medicine (ASLM) and the World Health Organization (AFRO, WHO).

The formation of AMDF was announced in a satellite symposium at the African Society for Laboratory Medicine Conference on 3rd December 2012 in Cape Town. The EAC Regional Task Force on Regulation of Medical Devices and Diagnostics meeting which was held in April 2013 in Dar-Es-Salaam approved the proposed structure which was presented at the 1st African Regulatory Forum on Medical Diagnostics in July 2013. In the same year, June 2013, AMDF officially requested to work under the African Medicines Regulatory Harmonization (AMRH) Framework so that AMDF Secretariat is set up in NEPAD and the Chairperson was given seat as a member of the AMRH Advisory Committee.

It is based on this background that in April 2018, the 2nd meeting of the Steering Committee (SC) on Regulatory Systems Strengthening and Harmonization Initiatives in Africa, as a successor of the AMRH Advisory Committee, approved the alignment of AMDF as part of the new AMRH Governance Framework.

The SC directed the AMDF to work out modalities of establishing a Technical Working Group (TWG) on medical devices and diagnostics regulation in Africa under the AMRH Program. This is in line with alignments of various harmonization initiatives and networks that have been ongoing in different aspects of regulatory functions with a view to ensure that all the African Union (AU) Member States benefit from technical and scientific guidance provided through these efforts. It is also expected that the AMDF will serve a technical role for the African Medicines Agency (AMA) once the latter is established and operational.

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