Pan African Harmonisation Working Party
- African Forum
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
Goal: A Common Registration File for IVD Medical Devices using point-of-care tests for CD4, viral load and early infant diagnosis as examples
Goal: To reduce duplication, costs and delays associated with regulatory audits of manufacturers' quality management systems
Goal: Reduced duplication of studies for regulatory approval in African countries
Goal: Safe, reliable diagnostic products across Africa
Goal: Standardised rules for classifying IVD for their regulation based on risk to individual and public health