WHO Listed Authority (WLA)

The WLA framework replaces the procurement-oriented concept of stringent regulatory authorities, first defined by the Global Fund in 2008. To be eligible, an authority must have reached overall maturity level 3 on the WHO Global Benchmarking Tool or be on the list of transitional WLAs; it should then demonstrate, through a performance evaluation, compliance with the requirements for the functions or product categories for which listing is sought. The transitional list is valid until 31 March 2027; a listing is initially valid for 5 years. The 2024 answers give medicines and vaccines as the initial scope; WHO's WLA page shows a list of transitional WLAs for medical devices dated 14 July 2026.

WHO calls reliance central to its approach: regulators and procurement agencies relying on WLA work and decisions reduces redundancy. In UNDP's REQ-OXY-001 (effective 1 January 2025), authorization by a WLA for the relevant product stream and regulatory functions is one of four routes for Class B, C and D medical devices, with WHO prequalification, clearance by listed regulators and recommendation by the WHO Expert Review Panel. The Global Fund's quality assurance policy (amended 15 November 2023) also accepts Class C or D medical devices, other than in vitro diagnostics, authorized by a WLA within its scope of listing.