In vitro diagnostics and laboratory technology

Guidance and training

Guidance for Manufacturers

1. TECHNICAL GUIDANCE SERIES FOR WHO PREQUALIFICATION
The Prequalification Team – Diagnostics is developing a Technical,Guidance Series for manufacturers interested in WHO prequalification of,their IVD and will assist manufacturers in meeting prequalification,requirements. It should be read in conjunction with relevant,international and national standards and guidance.
TGS 1 Standards applicable to the WHO Prequalification of in vitro diagnostics
TGS 2
Establishing stability of an in vitro diagnostics for the WHO Prequalification Comment period closed
TGS 3 Principles of performance studies Comment period closed

2. SAMPLE PRODUCT DOSSIER FOR WHO PREQUALIFICATION
The Prequalification Team – Diagnostics have prepared sample product,dossiers based on a fictitious IVD to provide manufacturers with an,example of the type of information that may be included in a product,dossier submitted to WHO Prequalification.
Sample Product,Dossier for a CD4 IVD
Sample Product Dossier for an IVD intended,for HIV self-testing Comment period closed
Sample Product Dossier for a Qualitative,Nucleic Acid Test for HIV-1 and HIV-2 Comment period closed

3. TECHNICAL SPECIFICATION SERIES FOR WHO PREQUALIFICATION
The Prequalification Team – Diagnostics is developing a Technical,Specification Series for manufacturers interested in WHO,prequalification of their IVD. This series will set out appropriate,performance evaluation criteria to meet PQ requirements.
TSS 1
Technical specifications for WHO prequalification of HIV rapid diagnostic tests for professional use and/or self-testing NEW

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