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

TGS 3

Principles of performance studies

TGS 4

Test method validation for an in vitro diagnostic medical devices

TGS 5

Designing Instructions for use for in vitro diagnostic medical devices

Draft for comment

TGS 6

Panels for quality assurance and quality control of in vitro diagnostic medical devices

Draft for comment

 


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

Under review

Sample Product Dossier for a Qualitative,Nucleic Acid Test to detect HIV-1 and HIV-2 to detect HIV-1 and HIV-2

Sample Product Dossier for a Quantitative,Nucleic Acid Test to detect HIV-1 RNA

 


3. TECHNICAL SPECIFICATION SERIES SUBMISSION TO WHO PREQUALIFICATION – DIAGNOSTIC ASSESSMENT

The Prequalification Team – Diagnostics is developing a Technical,Specification Series for manufacturers interested in WHO,prequalification of their in vitro diagnostic medical device (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

TSS 2

Technical specifications for WHO prequalification of IVD medical devices to identify Glucose-6-phosphate dehydrogenase (G6PD) activity

 

TSS 3

Technical Specification Series for submission to WHO Prequalification – Diagnostic Assessment: Malaria rapid diagnostic tests

 


RECORDED TECHNICAL BRIEFINGS

WebEx session on "Dossier requirements for WHO prequalification of malaria rapid diagnostic tests (RDTs)" held on 20 April 2017.

EMERGENCY USE ASSESSMENT AND LISTING (EUAL) PROCEDURE


Global public consultation on WHO prequalification of similar biotherapeutic products

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