WHO announced AMTZ as a Support Cell for WHO Prequalification for In-Vitro Diagnostics (IVDx) on November 22nd 2017.The Cell would guide the IVD manufacturers from India and SEAR countries in getting their products prequalified and share the WHO expectations in this regard with manufacturers. This list of prequalified IVDx is used by international procurement agencies like UN Countries and WHO Member States and increasingly by countries to guide bulk purchasing of products.
1. Share WHO expectations for Prequalification (PQ) &Emergency Use Listing (EUL)with manufacturers
2. Engage early to provide guidance and information on specific requirements and needs for WHO-PQ/EUL
3. Work with manufacturers and optimize the assessment process.