In vitro diagnostics and laboratory technology

Prequalification of in vitro diagnostics

Role of WHO Prequalification Team - Diagnostics

1. Promote and facilitate access to safe, reliable and appropriate in vitro 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 in vitro diagnostics;
  • Policy, guidance and advocacy to Member States;
  • Provision of quality assurance programmes to countries;
  • Training and technical support including country projects.

2. Support two of WHO's six core functions:

  • setting norms and standards and promoting and monitoring their implementation
  • providing technical support, catalysing change & building sustainable institutional capacity

3. Contribute to achieving three of WHO's impact goals:

  • reduce under-five mortality
  • reduce maternal mortality
  • reduce the number of people dying from AIDS, tuberculosis and malaria