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

TGS 4

Test method validation for an in vitro diagnostic medical devices

NEW

 


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

Comment period closed

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

NEW

 


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

NEW

 


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


Request for Proposals

22 MARCH 2017

The Prequalification Team is publishing a request for proposals for consultancy services relating to - developing and maintaining the Quality Management Systems (QMS) and assuming the responsibility for on-going system maintenance and effectiveness of operations within the Prequalification Team.

The services required by the World Health Organization (WHO) are more fully described in the below attached Terms of Reference and Request for Proposals.

Proposals should be submitted to WHO in writing no later than 5 April 2017 at 17:00 hours Geneva time ("the closing date"), by email at the following address: mubangizid@who.int

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