In vitro diagnostics and laboratory technology

Guidance for manufacturers

Links to guidance documents by type

The WHO Prequalification Team – Diagnostic Assessment group develops and issues its guidance documents as part of the objective of WHO to improve access to safe, effective and quality in vitro diagnostic medical devices (IVDs). The guidance is intended to assist manufacturers of IVDs when seeking WHO prequalification assessment or when seeking eligibility for procurement by WHO and other UN agencies.

Guidance documents represent the WHO Prequalification Team’s current thinking on a topic, with a focus on:

  • IVDs eligible for WHO Prequalification assessment;
  • the intended use settings where the WHO prequalified IVDs are procured; and
  • the intended users of WHO prequalified IVDs.

How to provide input for guidance development

Guidance documents are published as a DRAFT on the WHO Prequalification website for a specified public comment period during which comments will be considered. For most documents published the comment period is two months, however, the length of time will vary depending on the document. To ensure that comments are considered before finalization of the guidance, comments should be submitted by the closing date using the public comment tables available for each document.

Comments should be submitted electronically to diagnostics@who.int

Emergency Use Assessment And Listing (EUAL) Procedure

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