WHO Medical Device Prequalification Adds Condoms, IUDs, CAD-TB

The World Health Organization (WHO) has expanded its prequalification programme for medical devices. Prequalification of male and female condoms and intrauterine devices (IUDs) moves from the United Nations Population Fund (UNFPA) to WHO. Computer-aided detection software for tuberculosis screening (CAD-TB) enters the programme, and male circumcision devices, which WHO previously assessed under a separate process, join WHO's broader medical device prequalification framework. WHO's medical device prequalification page dates the launch of these assessments to 25 September 2026.

Prequalification is a WHO programme, not a law. WHO assesses the safety, quality and performance of individual products and lists those that meet its requirements to guide procurement decisions by WHO Member States, UN agencies, funds and programmes, and other international or intergovernmental organizations. WHO's list of prequalified medical devices states that inclusion "does not imply any approval by WHO of the products and manufacturing sites in question (which is the sole prerogative of national authorities)". Prequalification is therefore not a national registration in any country.

What changed

• A new procedure replaces two earlier ones. WHO's prequalification procedure for medical devices (PQDx_464) supersedes WHO's earlier procedure for male circumcision devices and the procedure and key activities described in the WHO/UNFPA prequalification guidance for contraceptive devices (WHO Technical Report Series No. 1025, Annex 9). The technical specifications that continue to apply are referenced in PQDx_468, WHO's dossier instructions.
• UNFPA has stopped prequalifying contraceptive devices. WHO's transition page states that UNFPA "no longer undertakes prequalification or post-qualification activities in respect of contraceptive devices" and that this work will be carried out by WHO.
• CAD-TB software is eligible. WHO's announcement describes this as "bringing a digital health technology into the WHO prequalification programme".
• IVDs stay on a separate procedure. PQDx_464 excludes in vitro diagnostics (IVDs), which remain subject to WHO's separate IVD prequalification procedure.

Who can apply

WHO's eligibility table, updated 25 September 2026, lists five device types. For IUDs, only copper-bearing devices are listed:

Under WHO's eligibility criteria (PQDx_465), only the original manufacturer may apply: "WHO will not accept applications submitted by rebranders or applications of rebranded products." PQDx_464 defines a rebrander as a manufacturer that buys a finished product from another company and places it on the market under its own name or brand. PQDx_465 also sets a design lock-down criterion, but as published it refers to IVDs. WHO reserves the right to apply other criteria, and it confirms eligibility only after reviewing each pre-submission form. Manufacturers of other device types can contact WHO at diagnostics@who.int about future eligibility.

WHO's guidance page lists these technical documents:

• Male latex condoms: WHO/UNFPA technical specifications (Technical Report Series No. 1025, Annex 10) and guidance on stability studies (No. 1044, Annex 9).
• Female condoms: the WHO/UNFPA generic specification (No. 1052, Annex 5).
• Copper-bearing IUDs: the WHO/UNFPA technical specification for the TCu380A IUD (No. 1044, Annex 10).
• Personal lubricants (where part of a condom application): WHO/UNFPA specifications (No. 1067, Annex 6).
• CAD-TB software: technical specifications TSS/MDV-01.
• Male circumcision devices: WHO's 2012 framework for the clinical evaluation of these devices.

Key dates

On the eligibility page, the 2026 and 2027 dates follow a note that "based on the volume of applications, the products below will receive priority consideration during the initial assessment wave".

UNFPA-prequalified contraceptive devices during the transition

WHO's transition page sets the conditions for devices on its acknowledgment list. The list is not a WHO prequalification: WHO states that it "has not directly undertaken such activities", and the list does not mean that WHO has assessed or prequalified these devices. WHO reserves the right to remove a device from the list in cases that include, but are not limited to, the following:

• serious, major or critical non-conformities or concerns about quality, safety or performance are identified for the device or one of its manufacturing sites;
• the manufacturer fails, or is late, to meet any applicable post-qualification obligation. This includes notifying WHO of reportable changes under PQDx_121: planned changes, which "must be reviewed and approved by WHO prior to the implementation", and changes made since UNFPA listing that UNFPA did not assess and approve. It also includes taking part in, or allowing, routine or non-routine inspections of manufacturing sites;
• the manufacturer has not applied for WHO prequalification by 30 September 2028.

WHO's guidance page lists PQDx_121, the reportable-changes document, as "to be posted soon".

How an application works

WHO's procedure and fees page and PQDx_464 set out these steps:

1. Pre-submission form. The manufacturer emails the pre-submission form (PQDx_466) and supporting documents to diagnostics@who.int. WHO uses them to decide eligibility, whether the assessment will be full or abridged, and which regulatory version it will assess. The manufacturer has two opportunities to complete the form correctly; after that, the application is rejected.
2. Pre-submission meeting. "A pre-submission meeting is compulsory for all applicants who are new to WHO prequalification."
3. Acceptance and the 60-day window. Once WHO accepts the pre-submission form, the manufacturer signs a Letter of Agreement, pays the assessment fee and submits the product dossier through WHO's ePQS portal, not by email; new users must first register for ePQS access. WHO may terminate the application if all three steps are not complete within 60 days after WHO notifies the manufacturer of acceptance. A dossier or fee sent before WHO requests it will not be reviewed, and such fees are non-refundable.
4. Screening. If the dossier is incomplete, the manufacturer has two opportunities to supply the missing information.
5. Assessment. The dossier review, manufacturing site inspection and labelling review run in parallel. WHO reviews the dossier against the International Medical Device Regulators Forum (IMDRF) Essential Principles of safety and performance, and allows up to two corrective action plans and one dossier amendment. The inspection checks the quality management system and manufacturing practices against standards such as ISO 13485. WHO may inspect on site, carry out a desk assessment based on Medical Device Single Audit Program (MDSAP) or RRA inspection information, or both; WHO decides using a risk-based approach. The labelling review covers instructions for use, labels and promotional materials that contain device claims.
6. Decision. WHO decides only after all three components are complete. A listing covers a specific product name, product codes, regulatory version and the inspected manufacturing sites, and WHO publishes a public assessment report.

A first-time applicant may submit only one application until WHO has completed that product's dossier review and confirmed in writing that further applications may follow. If WHO terminates an application, the manufacturer cannot reapply for that product for one year unless WHO agrees otherwise.

WHO target timelines

WHO's timelines page sets these targets, in calendar days from the start of formal assessment:

The targets cover all of WHO's review activities and the listing decision. Review starts after the fees are paid. The clock stops while WHO waits for a manufacturer's response and during any extension granted at the manufacturer's request. Pre-submission review and dossier screening fall outside the targets; WHO aims to complete each screening round within 30 days.

Most manufacturer response windows in WHO's tables are 30 days. Extensions are capped at six months for the dossier review, two months for the labelling review, six months for inspection steps and six months for a change assessment. A request must come in writing from the manufacturer's authorized contact before the deadline, with a justification; if more time is needed than WHO allows, the applicant may be asked to withdraw and reapply later. WHO warns: "Failure to comply with deadlines without prior notice or justification will result in termination of the application."

Full or abridged: which approvals count

An abridged assessment has the same three components as a full one but uses an abridged dossier. Under WHO's abridged assessment document (PQDx_470), a product is in principle eligible for it if the regulatory version submitted to WHO was "stringently assessed and approved" by an RRA in one of the risk classes below. It is also eligible if another regulatory version of the product has that approval and WHO judges that the two versions have no substantial differences.

An approval does not count if the authority relied on, recognized or abridged another regulator's assessment, or if it covered a lower or different risk class from those listed. Approval by any authority outside the table does not count either: the procedure and fees page states that "Manufacturers whose products have been approved only by non-RRA national authorities are not eligible for the abridged pathway." WHO may move a product from the abridged to the full route at any stage if the evidence is unsatisfactory, and for some product types or intended uses only full assessment may be available.

Published fees

The procedure and fees page sets these fees for 2026/2027:

Under WHO's fee terms (PQDx_471), fees are non-refundable, and paying them does not imply any WHO decision. WHO invoices the assessment fee after accepting an application, and the manufacturer pays within 30 days unless the invoice sets another deadline; if the fee is not paid in full and on time, the application is terminated. WHO decides case by case whether a change assessment fee applies; PQDx_471 describes it as a fee per product, while the fees page lists it per application. The annual fee applies to devices that, by 1 September of a given year, have been on WHO's list for 12 months or more (PQDx_464, Section 11.6). It is payable before 30 November of the year in which WHO issues the invoice, unless the invoice states another deadline. Neither document says whether the 2026 or 2027 rate applies to an application accepted near the turn of the year.

Pure Global calculation: every 2027 fee is 10% higher than the 2026 fee of the same type. Per product, the abridged assessment fee is 9,900 US$ lower than the full assessment fee at 2026 rates (18,700 − 8,800) and 10,890 US$ lower at 2027 rates (20,570 − 9,680). No annual fee falls due in the year of listing. A product listed on 1 July 2027 will have been listed for 14 months by 1 September 2028, so its first annual fee falls in 2028. A product listed on 1 October 2027 will have been listed for only 11 months by then, so its first annual fee falls in 2029. WHO's pages publish fees only for 2026 and 2027.

After listing

Under PQDx_464, Section 11, a product's prequalification status depends on its manufacturer meeting the post-qualification obligations, and failure or delay may lead WHO to suspend or delist it:

• Commitments: any prequalification commitments arising from the assessment must be met within the deadlines agreed with WHO.
• Changes: post-prequalification changes, such as modifications to components, manufacturing processes or the quality management system, must be reported to WHO and approved before implementation, as set out in PQDx_121.
• Post-market surveillance: the manufacturer must follow WHO's post-market surveillance guidance from the time WHO accepts the product for assessment.
• Inspections: routine inspections typically take place every three to five years, and WHO may inspect at other times in response to specific events.
• Technical specifications: the product must meet any WHO Technical Specifications Series or Technical Report Series requirements for its type. A product prequalified before a relevant specification is published has three years to comply.
• Annual fee: the fee must be paid when due.

WHO may also suspend or delist a product if serious or critical non-conformities are found, or if the product or a manufacturing site no longer meets WHO's requirements. The list page also states that the list "may not be used by manufacturers and suppliers for commercial or promotional purposes".

What this means for manufacturers

Pure Global analysis:

• UNFPA-prequalified contraceptive device manufacturers: three dates matter. Eligibility opens on 1 October 2026; WHO may remove a device from the acknowledgment list if no application has been made by 30 September 2028; and the acknowledgment ends no later than 30 September 2030. Applying by 2028 is not a safe harbour, because the removal grounds are not exhaustive and the acknowledgment itself is temporary, so plan for prequalification to be complete before the transition period ends. The first practical task is a change-control review: identify every reportable change made since UNFPA listing that UNFPA did not assess and approve, because WHO expects these to be notified, and planned changes need WHO approval before implementation. PQDx_121 is not yet posted, so ask WHO at diagnostics@who.int how to notify in the meantime. A manufacturer new to WHO prequalification that has several products can submit only one application until WHO has completed the first product's dossier review and, depending on the outcome and the manufacturer's readiness, confirmed in writing that more may follow. That makes early filing and the order of applications important.
• Products submitted to UNFPA but never accepted: such a product arguably fits both the 1 October 2026 wording ("previously submitted to the UNFPA") and the 1 April 2027 wording ("not previously submitted to and accepted by UNFPA"). Ask WHO at diagnostics@who.int which wave applies before submitting, rather than assuming either date.
• New contraceptive devices: these do not become eligible until 1 April 2027. Use the interval to check whether existing approvals match a qualifying RRA risk class in PQDx_470. A brand owner that buys finished condoms or IUDs from another manufacturer and sells them under its own brand cannot apply; the original manufacturer must. This differs from contract manufacturing: for IUDs, the eligibility table allows processes to be contracted out, while for condoms it requires the manufacturer to undertake the listed processes and does not mention contracting them out.
• CAD-TB software vendors: HTH policy endorsement is an eligibility condition, so confirm it before preparing a dossier, and confirm with WHO whether PQDx_465's design lock-down criterion, worded for IVDs, applies to the software version to be submitted. Then check the approvals held for the regulatory version to be submitted. A 510(k) clearance from the US Food and Drug Administration (FDA), or a Class IIb or Class III certificate of the listed Annex IX or Annex X and XI types under the EU Medical Device Regulation (MDR), can support the abridged route. PQDx_470 does not list an FDA De Novo grant as accepted evidence, an MDR Class IIa certificate does not qualify, and an approval obtained only through a reliance route does not count. WHO may also limit some product types to full assessment.
• Approvals outside the RRA table: the table in PQDx_470 (version 1) is a closed list. A product approved only by authorities outside it, such as Brazil's ANVISA, China's NMPA or India's CDSCO, goes through full assessment if WHO accepts it. WHO's transitional Listed Authorities list for medical devices is a separate framework: Pure Global has covered ANVISA's designation as a transitional WHO Listed Authority, but neither ANVISA nor NMPA, which is also on that transitional list, is an RRA in PQDx_470.
• All applicants: both routes include a site inspection and a labelling review. A recent MDSAP or RRA audit may support a desk assessment, but the choice is WHO's. Promotional materials that make device claims are part of the labelling review.

Prequalification informs UN and international procurement; it does not grant national market authorization. For an example of a national procedure that draws on WHO prequalification for IVDs, see Malaysia's participation in WHO's Collaborative Registration Procedure. For how national regulators classify and authorize AI medical-device software such as CAD-TB, see Pure Global's research on AI as a medical device and global market access.