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