Harmonization

Our aim is to study and recommend ways to harmonize medical devices and diagnostics regulation in Africa to ensure valuable, quality assured, safe medical devices and diagnostics are made available where needed.

We are prioritizing in vitro diagnostic (IVD) medical devices and our pilot projects will focus on devices to be used at the point of care.

We are currently working in five harmonization priority areas

1.   Common Registration File

Goal: A Common Registration File for IVD Medical Devices using point-of-care tests for CD4, viral load and early infant diagnosis as examples

2.   Quality Systems Audit

Goal: To reduce duplication, costs and delays associated with regulatory audits of manufacturers' quality management systems

3.   Clinical Evidence

Goal: Reduced duplication of studies for regulatory approval in African countries

4.   Post Market Surveillance

Goal: Safe, reliable diagnostic products across Africa

5.   Risk Classification

Goal: Standardised rules for classifying IVD for their regulation based on risk to individual and public health

We work in co-ordination with the Asian Harmonisation Working Party AHWP and the Latin American Diagnostic Association ALADDIV, the World Health Organisation WHO/AFRO WHO/PQ, the African Society for Laboratory Medicine ASLM and the London School of Hygiene & Tropical Medicine LSHTM

©2016 Pan African Harmonisation Working Party
Improving Access to Affordable Diagnostics