Guidance Documents

Four principal types of guidance documents can by consulted by manufacturers seeking prequalification:

  • guidance documents on specific aspects of prequalification of in vitro diagnostics
  • the Technical Specifications Series (TSS) documents provide clear requirements for WHO prequalification assessment and describe WHO's interpretation of the minimum validation and verification studies to be undertaken by the manufacturer in support of in vitro diagnostic (IVD) performance claims
  • the Technical Guidance Series (TGS) documents identy standards and guidance that contain valuable information on a range of issues that are encountered in the manufacture, verification, and validation of specific categories of IVD
  • sample product dossiers that serve as an example to manufacturers of the evidence that must be submitted for a particular category of IVDs in order to attain prequalification.

Applicants should consult relevant prequalification guidance, TSS and TGS documents, and the relevant sample product dossier, before submission of an IVD for prequalification. They may also find it useful to consult: