WHO Publishes Transitional List of WHO Listed Authorities for Medical Devices
The World Health Organization has published the List of transitional WHO Listed Authorities for medical devices, effective as of 1 July 2026.
The list is described as a time-limited transitional list of national or regional regulatory authorities established to support and facilitate regulatory reliance on medical devices.
According to the document, the list forms part of the transition from the term Stringent Regulatory Authorities to WHO-Listed Authorities for regulatory oversight of medical products, including medical devices.
Scope of the Transitional List
The transitional WHO Listed Authorities for medical devices cover medical devices, including in vitro diagnostics.
The document states that the ultimate responsibility and decision for use of the list remains with users, such as regulatory authorities and procurement agencies, depending on the specific context of use.
Authorities Included
The WHO transitional list includes authorities from several countries and regions.
The listed authorities include:
Australia — Therapeutic Goods Administration;
Brazil — Brazilian Health Regulatory Agency;
Canada — Health Canada;
China — National Medical Products Administration;
European Medical Devices Regulatory Network;
Republic of Korea — Ministry of Food and Drug Safety;
Japan — Ministry of Health, Labour and Welfare / Pharmaceuticals and Medical Devices Agency;
Russian Federation — Ministry of Health;
Switzerland — Swissmedic;
Singapore — Health Sciences Authority;
United Kingdom — Medicines and Healthcare products Regulatory Agency;
United States of America — Food and Drug Administration.
For all authorities listed, the scope of designation covers medical devices, including in vitro diagnostics.
European Medical Devices Regulatory Network
The document notes that the European Medical Devices Regulatory Network is composed of the European Commission and the regulatory authorities of EU/EEA-EFTA countries.
This includes countries such as Austria, Belgium, France, Germany, Ireland, Italy, the Netherlands, Norway, Portugal, Spain, Sweden and others listed in the document.
Transitional Nature of the List
The WHO notes that the precise scope of designation for transitional WHO Listed Authorities for medical devices will be further defined in agreement with each regulatory authority as part of the roadmap for designation as a WLA for medical devices.
The list is built on the existing list of recognised regulatory authorities by the WHO Prequalification for medical devices and membership of the Management Committee of the International Medical Devices Regulators Forum, as of 30 June 2026.
The document also states that the tWLA-MD is a risk-based evaluation process and will be valid for five years from the date of publication of the WHO guidance on the process and requirements for performance evaluation of candidate WLAs-MD.
Impact on Medical Device and IVD Manufacturers
For medical device and IVD manufacturers, the WHO transitional list is relevant because it may support regulatory reliance pathways and international regulatory cooperation.
Manufacturers should pay particular attention to:
jurisdictions included in the transitional list;
reliance mechanisms used by regulatory authorities or procurement agencies;
scope of designation for medical devices and IVDs;
future clarification of the precise scope for each authority;
alignment with WHO Listed Authority developments;
potential implications for global market access strategies.
For manufacturers operating across multiple markets, the list may provide useful context for regulatory planning, reliance strategies and interactions with authorities that use WHO frameworks.
