African Medical Devices Forum
- African Forum
The vision of AMDF is to enable access to medical devices and diagnostics of assured quality, safety and performance across Africa
The mission of the AMDF is to study and recommend ways to harmonize medical devices and diagnostics regulation in Africa
Regulatory Authorities, medical device and diagnostics industry representatives, regional economic communities (REC), National Laboratories, National Research Institutes
To establish a harmonized framework for regulation of medical devices including in vitro diagnostics in Africa based on the WHO global model for Medical Devices Regulatory Framework Model.
AMDF’s scope of work includes capacity building on; registration and common dossier submissions; quality audit and inspection; clinical performance studies; and post-market surveillance. The AMDF will also be responsible for conducting training programmes and providing resources to NRAs as part of capacity building.
Members co-opted as recommended and approved in PAHWP meetings.
Observers: other interested organisations.
Joint Secretariat : WHO and AUDA-NEPADThe AMDF will operate under the AMRH Governance structure depicted under Figures 1 & 2 below:
Figure 1: AMRH governance framework