Obtaining prequalification of an in vitro diagnostic (IVD) may demand considerable investment, in terms of both financial investment and staff time (to improve production quality and/or to prepare a dossier for submission and deal with any requests for further information from WHO). But benefits may accrue to a manufacturer during and following product prequalification.

 I.      Increased technical capacity

The landscape for IVDs is complex: not only with respect to their development and production, but also their regulation. By participating in WHO prequalification for IVDs manufacturers can develop a deeper understanding of how to meet international standards for quality-assured production of IVDs. This can develop through application of WHO’s publicly available guidance relating to IVD prequalification, or when specific guidance is received from WHO during assessment of a product dossier, inspection of its manufacturing site(s) or review of the results of its performance evaluation. Manufacturers also report that one-to-one meetings with WHO assessors, such as those that take place before submission of a product dossier, are particularly helpful. WHO’s active participation in development and harmonization of IVD regulation also means that it can provide considerable guidance to manufacturers seeking to understand and navigate this difficult technical area. In brief, manufacturers involved in WHO prequalification may find that they:

  • Further develop their human resources for ensuring and managing quality manufacture
  • Enhance their capacity to ensure quality manufacture across their range of products
  • Increase or develop new capacity to understand and meet stringent regulatory requirements.

II.      Sales and market access opportunities

Prequalification is used by UN agencies, non-UN donor agencies, procurement agents and some low- and middle-income countries to guide their procurement of IVDs. Gaining prequalification for a product can therefore increase its eligibility for donor-sponsored tenders for IVDs. Procurers mention that as part of their screening of manufacturers, they often check whether a manufacturer has prequalified products in its portfolio since this is generally seen as a positive indicator with respect to the manufacturer’s quality standards overall.

In parallel, if they have not yet entered stringently regulated markets, manufacturers may find that by having participated in WHO prequalification they have become better equipped to do so. Their success in competing for contract manufacture for local markets may also increase.

  1.  Improved image or brand

WHO prequalification is a trusted and reputed symbol for safety, quality and efficacy across stakeholders. Manufacturers of prequalified products have reported that their image or product brand has improved following prequalification, and that their employees have welcomed prequalification status.

Additionally, the WHO Collaborative Procedure for Accelerated Registration that has been piloted with prequalified IVDs will offer manufacturers the possibility of getting their products onto markets in countries more quickly. This is where the manufacturer can opt for WHO-CRP to NRAs.


Any manufacturer of an IVD may apply for prequalification of its product(s), provided that the IVD in question is eligible for prequalification.


Any IVD submitted for prequalification must be:

  • Needed for a specified disease or disease state
  • Appropriate for use in resource-limited settings
  • Requested by a WHO Member State(s)
  • Recommended for use by WHO disease-specific testing guidelines.



In addition, several eligibility criteria are applied. That is, each product submitted for prequalification must:

  • Be manufactured by the original product manufacturer
  • Commercially available when submitted for prequalification assessment*
  • Of interest to UN organizations and other agencies carrying out procurement of IVDs
  • Belong to a product category for which there are yet no or few prequalified products.

* Any exemptions must be agreed upon by WHO before the submission of the application. Please contact WHO at diagnostics@who.int if you have any questions regarding product eligibility regarding your product’s commercial availability.


IVD products currently eligible for submission for prequalification

Analyte/pathogenIntended useTechnology
HIVDiagnosis of infectionRapid diagnostic test (RDT)Enzyme immunoassay (EIA)Nucleic acid test (NAT)
HIV-1/HIV-2Monitoring of infectionFlow cytometer for enumeration of lymphocyte subset including CD4+ T cells, or a technology that can be used at or near the patient (POC)NAT for measuring viral load
Hepatitis C virus (HCV)Diagnosis of infectionRDTEIA
HCVAid to diagnosis of infection and monitoring of anti-viral therapyNAT
Hepatitis B surface antigen (HBsAg)Diagnosis and monitoring of infectionRDTEIA
Hepatitis B virusMonitoring of infection and anti-viral therapyQuantitative NAT
Malaria parasitesDiagnosis of infectionRDT
Human papilloma virusDiagnosis of infection (for cervical cancer prevention)NAT
G6PD enzymeEnzyme deficiency detectionTechnologies/formats to be used at or near to POC
Toxigenic Vibrio choleraeDetection of outbreaks or surveillance for the diseaseRDT
Treponema pallidum (syphilis)Screening and aid to diagnosis of infectionRDT
Mycobacterium tuberculosis complex and resistance to first and/or second line anti-TB drugsDiagnosis of infectionQualitative NAT
SARS-CoV-2Diagnosis of infectionRapid diagnostic testsQualitative nucleic acid tests

NOTE: This list is regularly updated as new IVDs are added to the prequalification scope, so be updated when you are about to apply for IVDs prequalification.


Before submitting an application for prequalification

New applicants should contact WHO before submitting an application for evaluation of an IVD. A pre-submission meeting is compulsory for all applicants who are new to WHO prequalification. (It is also recommended that manufacturers who have already submitted products for prequalification request a pre-submission meeting before submitting an additional product for prequalification.) Manufacturers can request a pre-submission meeting by contacting diagnostics@who.int. WHO can advise on all aspects of a submission, including dossier format and content. A good-quality dossier at submission will increase the likelihood that it passes screening. Moreover, a good-quality dossier is one of the most important determinants of time to prequalification.

Pre-submission meetings are also available to manufacturers who have already submitted products for prequalification.

WHO may also make recommendations regarding organization of technical assistance if it considers that a manufacturer should work on a specific technical issue or problem area before submission of an application.


Able to apply for WHO harmonization and collaborative procedures to NRAs i.e., TMDA, this will have great advantage to manufacturer’s/applicant’s business. This information has been well explained in our previous article which can be accessed through this link

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