The African Medical Devices Forum (AMDF), formerly known as the Pan-African Harmonization Working Party (PAHWP), is a technical committee under the African Medicines Regulatory Harmonization (AMRH) programme. The forum is jointly hosted by the Secretariats of the African Union Development Agency – NEPAD (AUDA-NEPAD) and the World Health Organization (WHO).

Established in 2012, AMDF’s primary mandate is to advance the harmonization of medical device regulation across Africa, guided by the WHO Global Model for Medical Devices Regulatory Framework. In June 2013, AMDF was formally recognized as a Technical Committee under the AMRH initiative.

In 2024, AMDF was restructured into two distinct entities: the AMDF Forum and the Medical Devices Assessment Technical Committee (MDA-TC). This reform was undertaken to strengthen technical support for the operationalization of the African Medicines Agency (AMA) and to ensure effective delivery of the mandate and objectives for regulating medical devices (MDs) and in vitro diagnostics (IVDs), in alignment with the operational model of other continental Technical Committees under the AMRH. The Tanzania Medicines and Medical Devices Authority (TMDA) is represented in the MDA-TC by one member.

Participation in the AMDF provides several benefits, including:

1. Training and capacity building
2. Development and review of technical documentation
3. Information sharing

Training and capacity building

The following trainings have been conducted in collaboration with AMDF:

1. Condom testing training conducted by UNFPA in Tanzania which was coordinated by AMDF
2. Training on assessment of technical files for marketing authorization of IVDs by SAUDI FDA
3. Training on Assessment of Technical Files for Blood Screening IVDs by PEI
4. AMDF e-Learning course on Basic Fundamentals of In Vitro Diagnostic (IVD) Medical Device Regulation
5. Training on assessment of medical devices and diagnostics dossier to African regulators conducted by TMDA

Collaborations

TMDA has collaborated with the AMDF Secretariat in the following areas:

1. Development and update of COVID-19 in vitro diagnostics which is available for sharing
2. List of MDs and other products for surveillance, prevention control and case management of COVID - 19
3. Establish a mechanism to receive feedback on substandard and falsified IVDs, medical devices and PPEs and inform National Regulatory Authorities
4. Development of guidance on management of IVDs and medical device`s donations
5. Drafting guidelines for marketing authorization and post market surveillance. These guidelines are still under review

Developing Continental tools for responding to Mpox crisis in Africa

1. Continental standard operating procedures for receiving, distribution and assessment of dossiers for IVDs
2. Templates for evaluation of New, Renewal and Variations applications for IVDs
3. Templates for preparation of public assessment reports for registered IVDs
4. Guidance for assessment based on the IMDRF Table of Content

Joint Assessment

TMDA participated in two joint assessment sessions for Mpox applications, coordinated by AUDA-NEPAD, held in South Africa in May and August 2025.

For more details on AMDF please click here