In vitro diagnostics and laboratory technology

Prequalification of in vitro diagnostics

The goal of the Prequalification Team - Diagnostics is to promote and facilitate access to safe, reliable and appropriate diagnostic technologies and laboratory services in an equitable manner through:

  • Prequalification of in vitro diagnostics for high burden diseases;

  • Capacity building of national regulatory authorities and national reference laboratories;

  • Facilitation of procurement of affordable and appropriate diagnostics;

  • Policy, guidance and advocacy to Member States;

  • Provision of quality assurance programmes to countries;

  • Training and technical support including country projects.

WHO has streamlined the procedures for prequalification assessment of in vitro diagnostics through the WHO Prequalification of In Vitro Diagnostics Programme. Updated procedural documents and expanded guidance for manufacturers will be posted on this website continuously from May 2014.

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It will provide a forum at which diagnostic, pharmaceutical and vaccine manufacturers, together with quality, safety and efficacy experts, procurement agencies, and international donors working in public health, can come together to discuss issues around production and supply of quality products needed for treatment for vulnerable populations.