WHO Launches Medical Device Prequalification in September 2026: Condoms, IUDs and Tuberculosis Screening Software (CAD-TB) Added to Scope

Published 3 October 2026, 13:31 — Registration and Market Access

Event: WHO launches medical device prequalification

On 25 September 2026, the World Health Organization (WHO) issued an announcement formally launching prequalification (PQ) assessment for medical devices. Previously this process covered only in vitro diagnostics (IVDs) and male circumcision devices; the scope now extends to condoms, intrauterine devices (IUDs) and tuberculosis screening software.

WHO prequalification is not a substitute for national registration or approval. It is a separate assessment process used to verify whether a product meets WHO requirements for quality, safety and performance. Products that pass are entered in the WHO list of prequalified medical devices, which United Nations agencies, procurement organisations and national authorities use as a basis for purchasing. For device manufacturers seeking access to international public procurement, this is an action worth planning for in advance.

Which product categories are newly added

According to the list published by WHO (table updated 25 September 2026), five device types can currently be submitted for assessment:

• Male latex condoms
• Female condoms
• Copper-bearing intrauterine devices
• Computer-aided detection software for tuberculosis screening (CAD-TB)
• Male circumcision devices

The inclusion of CAD-TB deserves separate mention. It uses digital chest radiography combined with automated image analysis to determine which individuals may have tuberculosis and require further testing. This is the first time WHO prequalification has included a digital health technology.

Responsibility for assessing condoms and IUDs has transferred from the United Nations Population Fund (UNFPA) to WHO. Male circumcision devices previously followed a separate pathway and are now integrated into the unified device framework. According to WHO, this consolidates the assessment of priority health products in one place and keeps the approach consistent.

Key dates

25 September 2026 is the official launch date. From 1 October 2026, the first assessment window opens, accepting three categories of submissions: products already submitted to UNFPA, CAD-TB products, and male circumcision devices. Change applications for contraceptive devices already on the current UNFPA list will also be accepted from the same date.

For contraceptive devices that have never been submitted to UNFPA, the application window opens only on 1 April 2027. This difference in timing means manufacturers aiming for early entry into the assessment process need to determine clearly which category their product falls into.

Who can apply

WHO has set eligibility thresholds for applicants. Taking condoms as an example, the manufacturer must itself carry out the formulation, compounding, dipping, lubrication and testing steps; where pre-vulcanised latex is used, the manufacturer must at minimum complete final assembly, testing and packaging of the finished product in its own facility. Agents, distributors or suppliers that only perform testing, lubrication and primary packaging are not eligible to apply.

For copper-bearing IUDs, some operations may be outsourced, but the manufacturer bears ultimate responsibility for product quality. Where a lubricant falls within the scope of the application, it must already be approved by a WHO-recognised regulatory authority of reference (RRA).

What WHO says

WHO notes that around 70% of countries report that their regulatory systems for medicines and vaccines are underdeveloped or weak, and that other health products face even greater challenges. The purpose of prequalification is to give countries with limited regulatory capacity a dependable basis for judging quality.

WHO Chief Scientist Sylvie Briand stated that everyone should have access to medical devices that are safe, effective and meet quality standards, and that expanding prequalification strengthens confidence in these essential products.

Sources and scope of application

Source: World Health Organization (WHO) news release, 'WHO announces expansion of prequalification programme for medical devices', 25 September 2026: https://www.who.int/news/item/25-09-2026-who-announces-expansion-of-prequalification-programme-for-medical-devices

Source: WHO Prequalification of Medical Products: Medical Devices (including launch description and key dates): https://extranet.who.int/prequal/medical-devices

Source: WHO medical devices eligible for prequalification (table updated 25 September 2026): https://extranet.who.int/prequal/medical-devices/medical-devices-eligible-prequalification

Verification scope and access date: this article verified the three WHO web pages cited above; the access date was 3 October 2026. All dates, categories and eligibility thresholds in the article are taken from the original text of the official pages.

Scope of application: this article is an interpretation of publicly available WHO regulatory information and does not constitute a determination or commitment regarding the outcome of any specific product, company or prequalification application. The scope of categories, timelines and application conditions are subject to the official WHO original text and may change with subsequent official updates.

AIMEILI Regulatory Interpretation

Prequalification is a procurement gateway, not a market authorisation

The expansion should be read first as a procurement decision. WHO PQ status does not replace national registration in any jurisdiction; it signals to UN agencies, institutional buyers and ministries of health that a device has been assessed against WHO quality, safety and performance expectations. In practice, PQ listing frequently becomes a tender prerequisite for global health procurement, so the commercial consequence of the programme expansion is felt at bid stage rather than at registration stage.

Consolidation of the UNFPA and WHO assessment pathways

Moving condoms and IUDs from UNFPA assessment into WHO PQ creates a single quality benchmark across previously parallel routes. Manufacturers holding UNFPA documentation will need to map their existing technical files, test reports and site records onto WHO PQ expectations, and to treat WHO as the reference body for future changes. The unified male circumcision device pathway follows the same logic.

Digital health enters prequalification for the first time

CAD-TB is the first software product to enter the WHO medical device PQ framework. This places software performance validation, algorithm version control, dataset representativeness and post-market performance monitoring within a prequalification evidence package for the first time. Regulatory teams used to hardware dossiers should expect the assessment model to emphasise software lifecycle evidence and change management rather than physical manufacturing controls.

Manufacturing control is the eligibility test

The eligibility rules make clear that PQ is directed at entities that actually control manufacturing. For condoms, formulation, compounding, dipping, lubrication and testing must be performed by the manufacturer, with pre-vulcanised latex permitting only final assembly, testing and packaging in the applicant's own facility. Agents, distributors and suppliers performing testing, lubrication and primary packaging alone cannot apply. Contract manufacturing arrangements must therefore be reviewed against these criteria before any submission is prepared.

Business Impact for Manufacturers, Distributors, CROs and Regulatory Affairs Teams

• Contraceptive and IUD manufacturers with UNFPA dossiers: the window opening on 1 October 2026 is the earliest route into assessment. Portfolio planning should map each product now to one of two tracks — submitted to UNFPA, or never submitted — because the second track cannot be filed before 1 April 2027.
• Lifecycle management for UNFPA-listed devices: change applications for contraceptive devices on the current UNFPA list are accepted from 1 October 2026. Site transfers, formulation changes and specification updates should be re-routed through the WHO PQ framework rather than handled as legacy UNFPA variations.
• CAD-TB developers: WHO PQ status is likely to become a de facto reference point for public-sector tuberculosis screening procurement. Clinical performance evidence, validation datasets, software versioning, cybersecurity and post-market performance monitoring should be structured to regulatory expectations well before submission.
• OEM, ODM and contract manufacturing partners: because the critical condom production steps must sit with the manufacturer itself, outsourcing formulation, compounding, dipping or testing will disqualify an application. Manufacturing and supply agreements should be audited against the eligibility text first.
• Distributors and agents: entities limited to testing, lubrication or primary packaging are not eligible applicants. Commercial partners should confirm that the legal manufacturer is the applicant of record and that local distribution roles are not presented as manufacturing activity.
• CROs and regulatory consultancies: demand is likely to grow for gap assessments against WHO PQ requirements, technical file assembly, manufacturing site documentation, and evidence of RRA approval where a lubricant falls inside the scope of the application.
• Procurement and market access teams: UN agencies and institutional buyers will increasingly reference the WHO prequalified medical device list. PQ status can therefore affect tender eligibility, award timelines and the ability to bid on framework agreements for reproductive health and tuberculosis programmes.

This interpretation reflects AIMEILI's reading of the WHO pages cited above as of 3 October 2026 and is intended to support internal planning. It does not constitute a regulatory decision, an eligibility opinion or a guarantee of prequalification outcome for any product.