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

New! PQDx guidance for public comments

EMERGENCY USE ASSESSMENT AND LISTING (EUAL) PROCEDURE


Request for Proposals

22 MARCH 2017

The Prequalification Team is publishing a request for proposals for consultancy services relating to - developing and maintaining the Quality Management Systems (QMS) and assuming the responsibility for on-going system maintenance and effectiveness of operations within the Prequalification Team.

The services required by the World Health Organization (WHO) are more fully described in the below attached Terms of Reference and Request for Proposals.

Proposals should be submitted to WHO in writing no later than 5 April 2017 at 17:00 hours Geneva time ("the closing date"), by email at the following address: mubangizid@who.int

ESSENTIAL MEDICINES AND HEALTH PRODUCTS


Contact us

Prequalification Team - Diagnostics
Regulation of Medicines and other Health Technologies
Department of Essential Medicines and Health Products
(HIS/EMP/RHT/PQT)
World Health Organization
20 Avenue Appia
1211, Geneva 27
Switzerland
diagnostics@who.int