FOOD AND DRUGS AUTHORITY – GHANA ELECTED CHAIR OF THE FIRST MEDICAL DEVICE ASSESSMENT TECHNICAL COMMITTEE (MDA-TC) OF THE AFRICAN MEDICAL DEVICES FORUM (AMDF) IN MAPUTO

The Food and Drugs Authority (FDA) is delighted to announce that it has been elected as the Chair of the newly established Medical Devices Assessment Technical Committee (MDA-TC) of the African Medical Devices Forum (AMDF).

This significant milestone took place during the fourth edition of the African Medicines Regulatory Harmonisation (AMRH) Week, a crucial meeting in the ongoing efforts to expand access to quality-assured medical devices including In Vitro Diagnostic Devices (IVD), in Africa. The meeting took place in Maputo, Mozambique from 28th October to 1st November 2024.

At the meeting members of the AMDF who are from the 55 AU member states nominated and elected Mr. Emmanuel Nkrumah, the Director for Medical Devices, Cosmetics and Household Chemical Substances Directorate of the FDA unanimously as the Chair. The objectives of the MDA-TC are:

• coordinate the scientific evaluation of medical devices and in-vitro-diagnostics at the continental level.coordinate the scientific evaluation of medical devices and in-vitro-diagnostics at the continental level.
• facilitate harmonization of requirements and standards for assessments, registration and/or marketing authorization activities at Regional Economic Communities and NRA levels in Africa.

The MDA-TC is composed of nominated experts (representatives) from the Regional Economic Communities (REC’s) established under the African Medicines Regulatory Harmonization (AMRH) initiative, which is set to transition into the African Medicines Agency (AMA). The formation of the MDA-TC represents a significant step towards harmonizing and advancing the regulation of medical devices across the African continent.

Strategic Role and Objectives of the MDA-TC

The MDA-TC is mandated to establish and implement regulatory frameworks that promote the safety, quality, and performance of medical devices, including IVD kits across Africa. Under the leadership of Mr Emmanuel Nkrumah, the MDA-TC will focus on the following established objectives:

• Development of Continental Guidelines: To create documents, technical requirements, and regulatory guidelines to support the regulation of medical devices at the continental and regional levels.
• Expert Selection: To select and endorse experts/specialists to support various continental regulatory activities.
• Establishment of a Continental Regulatory Procedure: To lead the development of a standardized continental regulatory process for listing and/or certifying priority medical devices, including IVDs.
• Collaborative Evaluations: To convene and facilitate joint assessments of priority medical devices including IVDs.
• Promotion of Reliance Models: To support and advocate for the use of reliance models, such as the World Health Organization Collaborative Registration Procedure (WHO CRP), to improve regulatory efficiency across African nations.

Implications for Medical Device Regulatory Harmonization in Africa

The establishment of the MDA-TC and Ghana FDA’s position as its first chair underscores Africa’s commitment to harmonizing regulations for medical devices. The MDA-TC will support equitable access to safe, quality and good-performing medical devices, improve regulatory transparency, and reduce the time associated with medical device approval processes.The Ghana FDA’s leadership role in this committee reflects its dedication to advancing regulatory excellence across the continent. As a WHO GBT Maturity Level 3 National Regulatory Authority and a Regional Centre of Regulatory Excellence (RCORE) for all regulatory functions excluding only the lot release function, the FDA is uniquely positioned to drive the MDA-TC’s mission of promoting harmonization of regulatory standards and reliance/recognitions of regulatory decisions between and among countries on the continent. The FDA through the MDA-TC will work to build a resilient regulatory system that upholds the highest standards of safety, quality, and performance for medical devices including IVDs on the continent.This election does not only affirm the FDA’s regulatory expertise over a decade of medical device regulation but also represents a significant milestone for Africa’s medical device regulation.