On 14 July 2026, the World Health Organization (WHO) published its first interim list of regulatory authorities for medical devices, known as transitional WHO Listed Authorities (tWLAs). The list marks an important milestone in strengthening global regulatory cooperation and supporting regulatory reliance, helping countries provide people with more timely access to safe, effective and quality-assured medical devices.
Around the world, regulatory authorities play a critical role in protecting public health by ensuring that medical devices – from diagnostic tests and syringes to pacemakers, implants and imaging equipment – meet appropriate standards of quality, safety and performance before they reach patients. Yet reviewing increasingly complex medical technologies requires significant expertise and resources, which can be challenging for many regulatory authorities.
One way to address this challenge is through regulatory reliance. Rather than repeating the same scientific assessments independently, regulatory authorities can, where appropriate, make use of evaluations, inspections and other regulatory decisions already conducted by other regulators, while remaining fully responsible for their own decisions. This approach helps reduce duplication of effort, makes better use of limited expertise and resources, and can support more timely access to quality-assured 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. “This is ultimately about making regulatory systems stronger so they can better protect and improve people's health."
The transitional WHO Listed Authority 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 and offers regulators greater clarity on authorities that can serve as reference points for regulatory reliance. The initiative supports more efficient regulatory decision-making and contributes to strengthening regulatory systems worldwide.
The interim list forms part of WHO’s broader transition from the former concept of Stringent Regulatory Authorities (SRAs) to the WLA framework – a more transparent and performance-based system for recognizing regulatory authorities based on internationally accepted standards and WHO-defined indicators of regulatory performance.
The transitional designation is temporary. As regulatory authorities complete the WHO evaluation process and achieve permanent WLA status for medical devices, the interim list will be updated accordingly until the full WLA pathway is fully implemented.
By strengthening regulatory systems and promoting greater international cooperation, the WHO Listed Authority framework supports more efficient regulatory oversight and contributes to ensuring that people everywhere have more timely access to quality-assured medical devices.