The World Health Organization (WHO) has published its first interim list of regulatory authorities for medical devices, known as transitional WHO Listed Authorities (tWLAs), on 14 July 2026, according to a press release. The list marks an important milestone in strengthening global regulatory cooperation and supporting regulatory reliance. It is designed to help countries provide people with more timely access to safe, effective and quality-assured medical devices. The initiative reinforces WHO’s role in coordinating regulatory systems worldwide. It signals a shift toward greater efficiency in the oversight of medical technologies.
Regulatory authorities across the world play a critical role in protecting public health by ensuring that medical devices meet appropriate standards of quality, safety and performance before reaching patients. These devices range from diagnostic tests and syringes to pacemakers, implants and imaging equipment. However, reviewing increasingly complex medical technologies requires significant expertise and resources. Such demands can be challenging for many regulatory authorities. Regulatory reliance offers one way to address this challenge.
Through reliance, regulatory authorities can make use of evaluations, inspections and other regulatory decisions already conducted by other regulators, while remaining fully responsible for their own decisions. This approach reduces duplication of effort and makes better use of limited expertise and resources. It can also support more timely access to quality-assured medical devices. The tWLA recognizes national and regional regulatory authorities that have demonstrated established regulatory performance in the oversight of medical devices. It provides continuity while WHO finalizes the full WHO Listed Authority (WLA) evaluation pathway for medical devices.
“The transitional WHO Listed Authority is a critical step towards a more connected and efficient global regulatory system for medical devices. By strengthening cooperation and enabling regulators to build on each other’s work, we can make better use of limited resources and help countries provide people with faster access to safe, effective and quality-assured health products,” said Dr Rogério Gaspar, Director of WHO’s Department of Regulation and Prequalification.
He added that the effort is ultimately about making regulatory systems stronger so they can better protect and improve people’s health. The framework offers regulators greater clarity on authorities that can serve as reference points for reliance. It also supports more efficient regulatory decision-making.
The interim list forms part of WHO’s broader transition from the former concept of Stringent Regulatory Authorities (SRAs) to the WLA framework, which is more transparent and performance-based. The new system recognizes authorities based on internationally accepted standards and WHO-defined indicators of regulatory performance. The transitional designation is temporary and will be updated as authorities complete the WHO evaluation process and achieve permanent WLA status for medical devices. Updates will continue until the full WLA pathway is fully implemented. The framework contributes to ensuring that people everywhere have more timely access to quality-assured medical devices.
