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.

  • TGS 1 Standards applicable to the WHO Prequalification of in vitro diagnostics: TGS 1 identifies standards and guidance that contains valuable information on a range of issues that are encountered in the manufacture, verification, and validation of IVDs.

  • TGS 2 Establishing stability of an in vitro diagnostic for WHO Prequalification: TGS-2 provides IVD manufacturers with guidance on possible approaches to determine stability. More specifically it describes the requirements for WHO prequalification in terms of stability testing. (Comments to be submitted to no later than 29 February 2016)

  • TGS 3 Principles of performance studies:TGS 3 identifies the key principles that apply when conducting and reporting the study design, results, and conclusion of analytical and clinical performance studies that support performance claims for IVDs undergoing assessment for WHO prequalification. (Comments to be submitted to no later than 31 July 2016)

Related documents

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.

Areas to be covered

  • Advocacy and policy guidance for Ministries of Health and laboratory experts at regional and country level.

  • Training the "Trainers"
    • Quality Assurance
    • Biosafety
    • Organisation of EQAS
    • CD4+ Counting Skills

  • Country Project – An East African Initiative (AMREF) Implementation of Basic Operational Frameworks to improve the quality of laboratories in Kenya, Uganda and United Republic of Tanzania.



Contact us

Prequalification Team - Diagnostics
Regulation of Medicines and other Health Technologies
Department of Essential Medicines and Health Products
World Health Organization
20 Avenue Appia
1211, Geneva 27