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Prequalification Procedures and Fees: In Vitro Diagnostics

Prequalification Procedures and Fees: In Vitro Diagnostics

⚠️ Important Update – Changes to WHO’s Prequalification of IVD Assessment Procedure (from 2026)

Starting in 2026, WHO will introduce a new prequalification assessment procedure. The performance evaluation will no longer be part of the prequalification assessment and will become a separate procedure.

The information on this webpage reflects these upcoming changes. If you have any questions, please email WHO’s Prequalification of IVDs team at diagnostics@who.int.

This section helps potential applicants to understand how to apply for WHO prequalification of an in vitro diagnostic (IVD), what information to compile and the associated fees.

Guidance documents are available to support the applicant through the process.

Eligibility for WHO’s prequalification assessment

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

Applying for WHO’s prequalification assessment

1. WHO's performance evaluation (if applicable)

For certain IVDs, a WHO performance evaluation is a prerequisite. Manufacturers must first submit an Expression of Interest for performance evaluation.

  • See document PQDx_298  “Eligibility criteria for WHO’s prequalification assessment of in vitro diagnostics”for the list of IVDs requiring performance evaluation
  • See the Performance Evaluation webpage for further instructions
2. Pre-submission 

Manufacturers must request access to the ePQS portal to complete a pre-submission form (PQDx_015), along with supporting documentation, as detailed in PQDx_017 “Instructions for completion of the pre-submission form”.

Find relevant information on the webpage “Pre-submission”.

WHO reviews the submission for eligibility and notifies the manufacturer whether the product can proceed to prequalification assessment, including information on next steps and fees.

Prequalification assessment process

WHO reviews the submission for eligibility and notifies the manufacturer whether the product can proceed to prequalification assessment, including information on next steps and fees.

If a prequalification application is accepted, WHO’s prequalification assessment can take place through one of two pathways—namely, full or abridged prequalification assessment. 

WHO guidance  document “WHO’s abridged prequalification assessment…” provides further details on the abridged procedure

Find relevant information on the “Prequalification assessment”

Outcome of WHO’s prequalification assessment 

A product is only considered for listing after:

  • Completion of all assessment components
  • Completion of performance evaluation, if required

Prequalified products are listed on WHO’s website: WHO’s list of prequalified IVDs 

Public assessment reports are available:

  • (WHOPAR) : Prequalification Public Assessment Report (assessment summary + labelling)
  • (WHOPIR) : Prequalification Public Inspection Report (site inspection summary)

Post prequalification requirements

Manufacturers must fulfill post-prequalification obligations, including ongoing compliance, reporting, and surveillance.

Timelines

WHO and applicants must complete each step within defined deadlines. See the Timelines webpage for details on full and abridged assessments. 

Fees

Fees cover part of WHO’s costs in the prequalification process. Three types apply:

  1. Prequalification assessment fee per product
  2. Change assessment fee per product
  3. Annual fee per product

Full details are provided in the guidance “WHO’s prequalification assessment fees”