Is there WHO prequalification for PSA oxygen plants?

What WHO prequalifies

WHO prequalification (PQ) is a standardized process that assesses individual health products against WHO's requirements for quality, safety and performance, through review of product documentation, assessment of manufacturing quality systems and oversight after a product is prequalified. Its product streams include immunization devices, in vitro diagnostics, medical devices, medicines, vaccines and vector control products.

WHO launched prequalification assessments for medical devices on 25 September 2026. Its table of eligible types, updated the same day, lists male latex condoms, female condoms, copper-bearing intrauterine devices, computer-aided detection software for TB screening (CAD-TB) and male circumcision devices. WHO asks manufacturers of other medical device types to contact it to enquire about future eligibility. The immunization devices stream covers products for the storage, transport and administration of prequalified vaccines.

What UN and donor procurement accepts instead

• UNDP, REQ-OXY-001 (effective 1 January 2025): medical devices must meet one or more of four routes: WHO prequalification; market clearance by the regulators of Australia (TGA device licence), Canada (device licence), the European Union (under the EU medical devices directive or regulation, according to the enforcement dates), Japan (PMDA device licence) or the USA (FDA 510(k) clearance, premarket approval (PMA) or HDE approval); authorization by a WHO Listed Authority for the relevant product stream; or a recommendation by the WHO Expert Review Panel. UNDP lists the oxygen generator among the major components of an oxygen plant classified as medical device class C.
• Global Fund quality assurance policy for medical devices (amended and restated on 15 November 2023): for Class C and Class D medical devices, the routes are WHO prequalification, authorization by a regulator of a founding member of the GHTF, authorization by a WHO Listed Authority within its scope of listing, or a recommendation by the Expert Review Panel.
• UNICEF technical requirements for medical devices (October 2023): a valid market clearance by one of the founding members of the GHTF, issued by one of five listed regulatory authorities.
• WHO technical specifications for health facility based medical oxygen systems (31 December 2024): compliance with the national regulatory authority of the intended market and approval in the country of manufacture; where the national authority has no classification or regulation, it suggests clearance from a well-regulated market, such as CE marking for medical devices with the notified body indicated, or equivalent approval in an IMDRF or GHTF founding member country such as Australia, Canada or Japan.
• The 2020 WHO interim specification for PSA plants, which said it would expire two years after publication and which the December 2024 specifications supersede, asked for a free sales certificate from Australia, Canada, Japan, the USA or the European Community, for example an FDA or CE certificate.

UNDP and the Global Fund list WHO prequalification as one route among several, but on 23 October 2026 PSA oxygen plants were not among the device types eligible for it. For the pressure vessels of a plant, UNDP asks separately for the pressure equipment approvals of each market, such as ASME BPVC Section VIII certification in the USA; see pressure vessel markings.