Programme Expansion Overview
The WHO Medical Device Prequalification Programme, established in 2010 initially for diagnostics and subsequently expanded to include radiation equipment, oxygen concentrators, and injection devices, will now accept applications for reusable surgical instruments. The expansion follows a 2024 WHO Essential Surgery Package review which identified access to quality-assured reusable surgical instruments as a critical gap in LMICs.
Priority Device Categories
The initial expansion covers three instrument families: general surgical forceps and clamps, abdominal retractor sets, and basic laparoscopic instrument sets. Selection was based on frequency of use in WHO Essential Surgical Procedures, evidence of quality variance in LMIC supply chains, and availability of international standards (ISO 7153-1 and ISO 13402 series) to define performance requirements.
Expedited Pathway for LMIC Manufacturers
Manufacturers based in low- and middle-income countries (as defined by the World Bank income classification) are eligible for a 50% fee reduction and access to WHO's pre-submission technical advisory service. WHO has partnered with the African Medical Devices Forum and the Asia Pacific Medical Technology Association to promote awareness of the programme in target markets.
Integration with UN Procurement Systems
WHO Prequalified surgical instrument suppliers will be eligible for inclusion in the United Nations Supply Chain system and UNICEF procurement catalogues without additional qualification assessment. This integration is expected to significantly expand commercial opportunities for qualifying manufacturers in markets that rely on UN procurement channels for surgical instrument supply.