- All > WHO Prequalification of Medical Products > WHO-UNICEF-UN Project
- All > Diagnostics and Laboratory Technology > Evaluation of Diagnostics
- All > Diagnostics and Laboratory Technology > Quality Assurance
- Keywords > good quality in vitro diagnostics (IVDs)
- Keywords > prequalification - IVDs for use in treatment programmes
- Keywords > prequalification - vaccines, medicines, diagnostics and medical devices
- Keywords > prequalification of diagnostics
- Keywords > prequalification process
- Keywords > in vitro Diagnostic (IVD)
(2014; 5 pages)
The success of treatment programmes and the rational use of medicines depend critically on diagnostic products. In the absence of fully functioning regulatory mechanisms for in vitro diagnostics (IVDs) in many countries, the WHO prequalification of IVDs programme generates independent technical information that can be used by UN agencies, governments and other organizations when selecting IVDs for use in their health programmes.
Since its creation in 2008, the programme has undergone somechanges as WHO strives to identify quality-assured IVDs for use in Member States where they are needed most. This article describes the prequalification of IVDs programme, its processes, and how it fulfils its unique role.