In vitro diagnostics and laboratory technology

Prequalification of in vitro diagnostics

The World Health Organization (WHO) Prequalification of In Vitro Diagnostics (IVDs) Programme aims to promote and facilitate access to safe, appropriate and affordable in vitro diagnostics of good quality in an equitable manner. Focus is placed on in vitro diagnostics for priority diseases and their suitability for use in resource-limited settings.

IVDs PREQUALIFICATION PROCESS

If a product meets the prequalification requirements then it can become eligible for inclusion in UN procurement tenders.

Changes to a WHO prequalified in vitro diagnostic

This document provides manufacturers of WHO prequalified in vitro diagnostic medical devices (IVDs) with information on when and how they must report to WHO.

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