In vitro diagnostics and laboratory technology

Guidance and training

Guidance for Manufacturers

1. TECHNICAL GUIDANCE SERIES FOR WHO PREQUALIFICATION OF IN VITRO DIAGNOSTICS

The Technical Guidance Series is prepared for manufacturers submitting for WHO Prequalification assessment. The series is based on internationally recognized regulatory guidance, and provide concrete examples of how these should be interpreted in the context of WHO prequalification.

TGS 1

Standards applicable to the WHO prequalification of in vitro diagnostic medical device

TGS 2

Establishing stability of in vitro diagnostic medical devices

Draft

Annex to TGS 2

Establishing component stability for in vitro diagnostic medical devices. Case study: single-use-buffer vials for rapid diagnostic tests

Draft open for public comment

TGS 3

Principles of performance studies

TGS 4

Test method validation for in vitro diagnostic medical devices

TGS 5

Designing Instructions for use for in vitro diagnostic medical devices

Draft

TGS 6

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

TGS 7

Risk management for manufacturers of in vitro diagnostic medical devices

Draft open for public comment

 


2. SAMPLE PRODUCT DOSSIER FOR WHO PREQUALIFICATION OF DIAGNOSTICS

The sample product dossiers series is prepared for manufacturers to provide an example of the type of information to be included in a product dossier submitted to for prequalification assessment. Each sample dossier is based on a fictitious IVD. An alternative approach can be used if the approach satisfies the requirement of prequalification assessment.

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-based testing technology for HIV-1 and HIV-2 to detect HIV-1 and HIV-2

Sample Product Dossier for a quantitative nucleic acid-based testing technology to measure HIV-1 RNA

 


3. TECHNICAL SPECIFICATION SERIES FOR SUBMISSION TO WHO PREQUALIFICATION OF DIAGNOSTICS

The Technical Specification Series is comprised of sets of specifications specific to each type of IVD that is within the scope of WHO Prequalification. The series is prepared for manufacturerssubmitting to WHO Prequalification and for WHO prequalification assessors.The series describes WHO's interpretation of the minimum validation and verification studies to be undertaken by the manufacturer in support of IVD performance claims. The studies are designed to ensure the IVD will perform as intended in the settings where the WHO prequalified IVD will be used.

TSS 1

Technical Specification Series to WHO Prequalification - Diagnostics Assessment: HIV rapid diagnostic tests for professional use and/or self-testing

TSS 2

Technical Specification Series for submission to WHO Prequalification - Diagnostic Assessment: IVD to identify Glucose-6-phosphate dehydrogenase (G6PD) activity

 

TSS 3

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

TSS 4

Technical Specification Series for submission to WHO Prequalification – Diagnostic Assessment: IVDs used for the detection of high-risk Human Papillomavirus (HPV) types in cervical cancer screening

Draft open for public comment

TSS 5

Technical Specification Series for submission to WHO Prequalification – Diagnostic Assessment: Rapid diagnostic tests used for surveillance and detection of an outbreak of cholera

Draft open for public comment

 


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

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