Pre Qualification Cell

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Southeast Asia’s first WHO Prequalification Cell for In Vitro Diagnostics has been setup at AMTZ. This cell was formalized on November 22nd 2017.The Cell will promote local manufacturing of IVDs, it will also facilitate IVD manufacturers from SEA region in getting their products available on the WHO’s prequalified list. 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. Solicit manufacturers
  2. Open dialogue with them prior to commercialization
  3. Engage early to provide guidance and information on our specific requirements and needs
  4. Work with manufacturers optimize the assessment process

Objectives of the cell:

  1. To assess the quality, safety and efficacy of IVDs that address global public health priorities
  2. 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
  3. To accelerate assessment and increases chances of meeting PQ requirements



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