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 manucaturer's quality management systems
3. Clinical Evidence
Goal: Reduced duplication of clinical trials 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 IVDs for their regulation based on risk to individual and public health