Prequalification Procedure and Fees: Medical Devices
This section helps potential applicants to understand how to apply for WHO prequalification of a medical device (MD), what information to compile and the associated fees.
Guidance documents are available to support the applicant through the process.
Fees
Fees cover part of WHO’s costs in the prequalification process. The following fees apply for 2026/2027
Year | Full prequalification assessment | Abridged prequalification assessment | Change assessment | Annual fee |
|---|---|---|---|---|
| 2026 | 18 700 US$ per product | 8 800 US$ per product | 3 300 US$ per application | 4 400 US$ per product |
| 2027 | 20 570 US$ per product | 9 680 US$ per product | 3 630 US$ per application | 4 840 US$ per product |
Procedure
Pre-submission
1. Preparing a pre-submission
The manufacturer must submit a completed “Pre-submission form for WHO’s prequalification assessment of medical devices”, and the supporting documentation in by email to the WHO email address diagnostics@who.int, to provide summary information about the product, details of the regulatory version and the manufacturer. This information will enable WHO to determine whether the product is eligible for WHO’s prequalification assessment and, if so, the type of assessment (full or abridged) that will be applied. It is also used to determine the regulatory version intended for prequalification and to plan for each of the components of the prequalification assessment process.
2. ePQS access for new users
The assessment of applications for prequalification assessment of medical devices is conducted through the ePQS platform. The ePQS platform is the WHO dedicated portal for the submission of product dossier and other confidential information. New manufacturers are required to register to access to ePQS portal by completing the form “External Form - New ePQS Portal User” available to download ePQS login portal to request access to ePQS. Do not submit a product dossier by email or before the manufacturer receives instructions on the submission of the product dossier.
3. Documentation to be submitted
The instructions document “Instructions for completion of the pre-submission form for WHO’s prequalification assessment of medical devices” (see guidance section) provides guidance to the manufacturer when completing the pre-submission form template.
The manufacturer must submit a completed pre-submission form and supporting documentation to diagnostics@who.int.
4. WHO schedules a pre-submission meeting with the manufacturer
A pre-submission meeting is compulsory for all applicants who are new to WHO prequalification. The pre-submission meeting provides an opportunity for WHO and the manufacturer to discuss the product, clarify eligibility questions, confirm the appropriate assessment pathway (full or abridged), and identify any significant gaps in anticipated documentation. Manufacturers should prepare a brief product overview, proposed intended use, and any questions about dossier content or assessment requirements. New manufacturers are strongly encouraged to review the relevant WHO documents (see Guidance page) before the meeting. An introduction to the ePQS platform, can be requested by the manufacturer.
5. WHO decision on eligibility for WHO's prequalification assessment
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 depending on the type of assessment (full or abridged). ePQS dossier submission instructions are available at the following link.
Prequalification Assessment
WHO offers two types of prequalification assessments for medical devices: Full and Abridged
Full assessment
A full assessment includes
• review of a product dossier
• manufacturing site inspection
• labelling review.
Abridged assessment
Refer to the guidance “WHO’s abridged prequalification assessment of medical devices” for a detailed overview of the process.
The abridged assessment includes:
• review of an abridged product dossier
• manufacturing site inspection
• labelling review.
An abridged assessment may be applied:
• if a regulatory version of the submitted product submitted has previously been stringently assessed and approved by a recognized regulatory authority (RRA), or
• if a regulatory version of the submitted product has not been stringently assessed and approved by an RRA, but there is another regulatory version of the product that has been stringently assessed and approved by an RRA; and in WHO’s discretion, there are no substantial differences between the two regulatory versions.
A Recognized Regulatory Authority (RRA) is a national regulatory authority whose review process WHO considers to be sufficiently stringent to serve as a basis for abridged assessment. The current list of WHO-recognized RRAs is available in “WHO’s abridged prequalification assessment of medical devices”. Manufacturers whose products have been approved only by non-RRA national authorities are not eligible for the abridged pathway.
Dossier submission and screening
A product dossier must contain sufficient information for WHO to assess the safety, quality, and performance of the device. The content required to be submitted for an abridged dossier and full dossier differ, and the full content requirements for both abridged and full dossiers are set out in the "Instructions for compilation of a medical device product dossier (non-in vitro diagnostic) for WHO’s prequalification” and the "Product dossier checklist for WHO’s prequalification of medical devices" Relevant Technical Specifications Series (TSS) and Technical Report Series (TRS) documents specify minimum performance requirements by device type (see guidance section).
Once WHO receives a dossier (full or abridged), it will screen the dossier for completeness. If the dossier is incomplete, WHO will provide two opportunities for the manufacturer to
submit additional information within the set deadlines. If the dossier is complete, WHO will begin the dossier review.
Prequalification assessment components
WHO’s prequalification assessment includes three main components (dossier review, site inspection and labelling review). Each are described in detail in “WHO’s prequalification procedure for medical devices”. See Inspection section link here to prepare for a WHO prequalification manufacturing site inspection.
Outcome of WHO's prequalification assessment
A product is only considered for listing after completion of all assessment components.
Prequalified products are listed on WHO’s website: WHO’s list of prequalified medical devices
Public assessment reports are available on the WHO public report page.
- Manufacturers must fulfill post-prequalification obligations, including ongoing compliance, reporting, and surveillance. See the Post-prequalification Procedures and Fees: Prequalified Medical Devices pages.