Pre Qualification Cell

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WHO-Pre Qualification Cell at AMTZ 

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.

Functions of the cell: 

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.

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 IVDx
  4. Provision of Quality Assurance programmes;
  5. Training and technical support.

Key Highlights: 

Advantages of WHO-PQ: 

  1.  Affordability, Accessibility & Availability of Quality assured IVDx.
  2.  Access to United Nations procurement agencies and global market.
  3. Eligibility for international, donor-sponsored tenders for IVDx.
  4.  Improved capacity to manufacture products for entry into stringently-regulated markets
  5. Increased potential to compete successfully for contract manufacture for local markets.
  6. Enabler towards faster registrations & Regulatory approvals.
  7. Improved image or brand status associated with producing quality-assured products.

     

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