This Prequalification Procedures and Fees section is dedicated to enabling potential applicants to determine how, whether and what information they must compile in order to submit an application for WHO prequalification of an in vitro diagnostic (IVD).

Prequalification have drafted a series of guidance documents aimed at guiding potential applicants through the application and assessment procedure, which can be found at the bottom of the page.

Who can participate in WHO prequalification of IVDs?

Any legal manufacturer of an IVD can express an interest in having its IVD evaluated by WHO, provided that product is eligible for evaluation.

Refer to the webpage In Vitro Diagnostics Eligible for WHO Prequalification and the Prequalification guidance document “Eligibility criteria for WHO prequalification of in vitro diagnostics” provide a full overview of the eligibility principle and criteria.

Prequalification fees

Prequalification fees are levied to cover part of the costs associated with product dossier screening and review, performance evaluation commissioned by WHO, manufacturing site(s) inspection, review of labelling, dissemination of prequalification information, change assessment and dissemination of change information, and an annual fee is levied once the product is prequalified. The guidance document “Prequalification fees” provides full information on the fees levied.

Prequalification timelines

Manufacturers submitting applications for WHO’s prequalification assessment often have questions regarding deadlines as they await decisions from WHO Prequalification. Target deadlines are defined for all steps of WHO’s prequalification assessment and change assessment process.

In general the target deadlines for WHO assessment are as follows:

• Full assessment: 270 WHO calendar days if the alternative performance evaluation pathway is selected by the manufacturer, and 350 WHO calendar days if WHO coordinates the performance evaluation
• Abridged assessment: 100 WHO calendar days if the alternative performance evaluation pathway is selected by the manufacturer, and 180 WHO calendar days if WHO coordinates the performance evaluation

WHO target deadlines start after the application is confirmed to be complete and accepted. Full description of the deadlines applicable to both WHO and the manufacturer are outlined in the document “Prequalification assessment and change assessment target deadlines”.

Preparing for WHO’s prequalification assessment

1. Determining eligibility for WHO’s prequalification assessment

IVD products currently eligible for submission for WHO’s prequalification assessment are listed on the webpage In Vitro Diagnostics Eligible for WHO Prequalification | WHO - Prequalification of Medical Products (IVDs, Medicines, Vaccines and Immunization Devices, Vector Control)

2. Pre-submission 

In order to submit an application for WHO prequalification assessment, the manufacturer must request access to the ePQS portal and submit an application for WHO’s prequalification assessment using the template form and following the instructions provided. Find relevant information on the webpage “Pre-submission form”.

3. Prequalification assessment

Full assessment

If following submission of a completed pre-submission form, WHO has determined that the product in question should undergo full assessment, it will formally invite the manufacturer to submit a product dossier. Full assessment of an in vitro diagnostic (IVD) for prequalification has the following components:
•    review of a product dossier
•    performance evaluation
•    manufacturing site inspection
•    labelling review.

Abridged assessment

An in vitro diagnostics (IVD) submitted for WHO's prequalification assessment may already have received approval from a recognized national regulatory authority.  Full Assessment for prequalfication could therefore entail duplication of effort.  However, although prior regulatory approval may provide a level of assurance relating to the product's quality, safety and performance in countries where it is approved, this may not be the case in other jurisdictions, including resource-limited settings.  In such cases an abridged assessment may be appropriate, the aim of which is to avoid duplication of effort and reduce the time taken to prequalify a product and focusing on aspects where WHO prequalfication assessment brings added value.

In order to be considered acceptable for WHO’s abridged assessment, the product must meet the requirements for market entry in the respective regulatory jurisdiction. A full explanation is provided in the guidance document “Abridged Prequalification assessment”.

Abridged assessment consists of a: 

• review of an abridged product dossier 
• manufacturing site inspection of abridged scope
• performance evaluation
• labelling review. 

Preparing for prequalification assessment components

Manufacturers are recommended to refer to the relevant instructions, checklists and guidance documents when preparing for prequalification assessment.

• Refer to the guidance “Abridged Prequalification assessment” for a description of the products eligible for abridged assessment
• Manufacturers should compile and submit the product dossier as prescribed in PQDx_018 - Instructions for Compilation of a Product Dossier – IMDRF ToC and Table of Contents (TOC) Product Dossier Checklist.
• Refer to Technical specification series documents for information on the minimum performance requirements for WHO prequalification that should be met by a manufacturer to ensure that the in vitro diagnostic that is being submitted for prequalification is safe and performs optimally.
• Refer to the performance evaluation section of this website click here to prepare for the performance evaluation 
• Refer to Inspection section of this website https://extranet.who.int/prequal/inspection-services/vitro-diagnostics-and-male-circumcision-devices to prepare for a WHO prequalification inspection
• Refer to the document “Labelling review for prequalification assessment” to prepare for the labelling review of your product

4. Listing a prequalified product 

If a product meets prequalification requirements it is added to the WHO List of Prequalified In Vitro Diagnostics and becomes eligible for UN procurement. Following the product's inclusion in the list, the manufacturer will be responsible for:
•    fulfilling prequalification commitments
•    annual reporting
•    reporting of changes
•    meeting post-market surveillance obligations
•    preparing and opening the manufacturing site(s) for re-inspection
•    continued compliance with WHO prequalification technical specifications.

The decision to include the product in the WHO list of prequalified IVDs is made based upon information available to WHO at the time of the prequalification assessment, including information obtained as a result of the product dossier review, performance evaluation,  the inspection of manufacturing site(s) and/or the labelling review conducted by WHO. This decision is subject to change on the basis of new information that may become available to WHO.