In vitro diagnostics and laboratory technology

Guidance and training

Guidance for Manufacturers

1. Technical Guidance Series

The Prequalification Team – Diagnostics is developing a Technical Guidance Series for manufacturers interested in WHO prequalification of their IVD. The guidance will apply in principle to all IVDs that are eligible for WHO prequalification for use in WHO Member States and will assist manufacturers in meeting prequalification requirements. It has been developed by WHO with input from national regulatory authorities, national reference laboratories and WHO prequalification dossier assessors and inspectors. It should be read in conjunction with relevant international and national standards and guidance.

2. Sample Product Dossier for WHO Prequalification

The Prequalification Team – Diagnostics have prepared sample product dossiers based on a fictitious diagnostics to provide manufacturers with an example of the type of information that may be included in a product dossier submitted to WHO Prequalification.

Guidance for WHO Member States

The Prequalification Team - Diagnostics aims to provide guidance & specific training programmes for WHO Member States on a regional basis.

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