Pre Qualification Cell

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WHO announced AMTZ as a Support Cell for WHO Prequalification for In Vitro Diagnostics 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 IVDs is used by international procurement agencies like UN Countries and WHO Member States and increasingly by countries to guide bulk purchasing of products.

Functions of the cell:

  1. Share WHO expectations for Prequalification with manufacturers
  2. Engage early to provide guidance and information on our specific requirements and needs
  3. Work with manufacturers optimize the assessment process

Objectives of the cell:

  1. To promote and facilitate access to safe, affordable and appropriate in vitro diagnostic technologies and laboratory services of good quality and in an equitable manner
  2. To accelerate assessment and increases chances of meeting PQ requirements
  3. Engage in advocacy, capacity building of manufacturers for their readiness for WHO PQ of IVDs



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