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.

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.

PAHWP’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 PAHW will also be responsible for conducting training programmes and providing resources to NRAs as part of capacity building.

1. WHO Global Model Regulatory Framework for Medical Devices and IVDs recommendations adopted by members.

2. Regional, continental and internationally harmonized technical guidelines relating to Medical Devices and IVD Medical Devices developed and implemented;

3. Increased awareness of medical device regulation and established legal frame work and introduction of regulatory framework by more countries including adoption of GHTF definition, risk classification, registration of importers, distributors, listing of medical devices, post market surveillance, establish essential principles of safety and performance, establish basis for reliance and recognition, requirements for manufactures, declaration of conformity and requirements for labels and advertisement.

4. Improved collaboration, convergence, work sharing and networking amongst members for example: - harmonized registration requirements, acceptance of quality management system auditing reports, shared point for adverse events reports etc.

5. Collaboration with other harmonization initiatives such as AHWP, IMDRF, ASEAN, APEC and any other interested partner enhanced.