What We Do

We prequalify in vitro diagnostics

The  aim  of  WHO  prequalification  of  in vitro diagnostics (IVDs) is  to  promote  and facilitate access to safe, appropriate and affordable in vitro diagnostics of good quality in an equitable  manner. The focus is on IVDs for priority diseases  that are appropriate for use in resource-limited settings.

WHO IVD prequalification incorporates comprehensive assessment of individual IVDs through a standardized procedure, to determine whether the product meets WHO prequalification requirements. Assessment has three components:

  • review of a product dossier
  • laboratory evaluation of performance and operational characteristics
  • manufacturing site(s) inspection

Following prequalification post-market surveillance is undertaken. It includes reactive and proactive measures, through complaint reporting and post-shipment/pre-distribution lot testing. Post-qualification also includes mandatory manufacturer notification of changes to the product or the quality management system.

Dossier review

Transition to the International Medical Device Regulators Forum (IMDRF) Table of Contents (ToC) format for product dossier submissions

In March 2020, WHO IVD prequalification began its transition to the International Medical Device Regulators Forum (IMDRF) Table of Contents (ToC) format for product dossier submissions. WHO will move away from product dossiers that use the Global Harmonization Task Force (GHTF) Summary Technical Documentation (STeD) format.

Manufacturers should compile and submit the product dossier as prescribed in PQDx_018 v4 Draft: Instructions for Compilation of a Product Dossier – IMDRF ToC. This draft document is open for public comment until March 2021. Any comments may be directed to diagnostics@who.int.

Manufacturers may still submit their product dossier according to the current STeD format until April 2021, adhering to the instructions contained in: Instructions for compilation of a product dossier_PQDx_18 and Product dossier checklist  

WHO reviews the product dossier to:

  • assessing evidence in support of safety and performance of the product
  • determining whether the manufacturer's quality management system is of an adequate standard to warrant an inspection of the manufacturing site
  • assessing product design and manufacture.

If the dossier is incomplete, the manufacturer will be requested to submit additional information within a specified time period. Once a dossier has been accepted, assessment can proceed to the laboratory evaluation and manufacturing site inspection.

We prequalify male circumcision devices

WHO staff responsible for prequalification of IVDs also undertake prequalification of male circumcision devices.

The approach and standards applied to prequalification of  MCDs are very similar to those applied for IVD prequalification.

Our key outputs

The key outputs for WHO immunization devices prequalification are: