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:

• Share WHO expectations for Prequalification (PQ) &Emergency Use Listing (EUL)with manufacturers.
• Engage early to provide guidance and information on specific requirements and needs for WHO-PQ/EUL
• Work with manufacturers and optimize the assessment process.

Objectives of the cell:

• 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
• To accelerate assessment and increases chances of meeting PQ requirements
• Engage in advocacy, capacity building of manufacturers for their readiness for WHO PQ of IVDx.
• Provision of Quality Assurance programmes;
• Training and technical support.

Key Highlights:

Assistance in filing of application for WHO-PQ for all in-house indigenous manufacturers producing priority disease in-vitro diagnostics as per the listing of WHO. Complete hand holding for all in-house indigenous manufacturers