WHO announces first global list of medical device regulators eligible for listed authority standing
The World Health Organization (WHO) has published its first interim list of 12 global medical device regulators eligible for transitional listed status. Following evaluations, these authorities may transition to formal WHO-listed authorities (WLAs).
Under the WLA system, other countries' regulators can refer to that authority's review results for medical device approvals. This initiative is expected to streamline the authorization process for medical devices.
The transitional WLA system recognizes national and regional regulatory bodies that have demonstrated effective oversight of medical devices. This recognition provides a temporary pathway while WHO evaluates the regulator for WLA status.
WHO said this is an important step towards strengthening global regulatory convergence in the medical device sector.
The list includes Australia, Brazil, Canada, China, the European Union, the Republic of Korea, Japan, the Russian Federation, Switzerland, Singapore, the United Kingdom, and the US.
WHO announced that “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.”
The interim list is part of WHO’s broader transition from the previous concept of Stringent Regulatory Authorities (SRAs) to the new WLA framework.
WHO said the WLA framework strengthens regulatory systems and promotes greater international cooperation. As a result, it said the framework is intended to provide more efficient regulatory oversight and ensure patients across the globe have more timely access to quality medical devices.
"The transitional WHO Listed Authority is a critical step towards a more connected and efficient global regulatory system for medical devices,” said Rogério Gaspar, Director of WHO’s Department of Regulation and Prequalification. “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.
“This is ultimately about making regulatory systems stronger so they can better protect and improve people's health," he added.
The list is based on the current list of Recognized Regulatory Authorities established by WHO’s prequalification program for medical devices as well as their membership in the Management Committee of the International Medical Devices Regulators Forum (IMDRF) as of 30 June 2026.
WHO guideline; List of WHO listed authorities
