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: 

Procedure

Pre-submission

Preparing a pre-submission

Applications for prequalification assessment of medical devices are accepted through the ePQS portal. 

New manufacturers are required to register to access to ePQS portal by completing the form available at ePQS login portal.

The manufacturer must submit a completed “Pre-submission form for WHO’s prequalification assessment of medical devices” (see guidance section) and the supporting documentation in the WHO ePQS portal through the application wizard, 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.

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:
•    pre-submission form for WHO’s prequalification assessment of medical devices
•    authorization letter
•    instruction for use
•    abridged assessment eligibility annex.

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. 

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). 

Prequalification Assessment

WHO offers two types of prequalification assessments for in vitro diagnostic products: 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 and webpage on Timelines.

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 page