WHO Launches First Global List for Trusted Medical Device Regulators

The initiative is expected to help countries strengthen their regulatory systems while reducing unnecessary duplication in the approval of medical devices.

The World Health Organization (WHO) has introduced its first interim list of trusted regulatory authorities for medical devices, creating a new framework designed to improve international cooperation and speed up access to safe, effective and quality-assured health technologies. The initiative is expected to help countries strengthen their regulatory systems while reducing unnecessary duplication in the approval of medical devices.

New framework strengthens global cooperation

Published on 14 July 2026, the interim list introduces the transitional WHO Listed Authorities (tWLAs) for medical devices. The designation recognises national and regional regulatory authorities that have demonstrated strong regulatory performance in overseeing medical devices.

The interim system will remain in place while WHO completes the full WHO Listed Authority (WLA) evaluation pathway for medical devices. Once regulators complete the full assessment process, they will move from the temporary designation to permanent WLA status.

WHO says the framework replaces the previous concept of Stringent Regulatory Authorities (SRAs) with a more transparent, performance-based system built on internationally accepted standards and clearly defined indicators of regulatory performance.

Faster access to safe medical devices

Medical devices such as diagnostic tests, syringes, pacemakers, implants and medical imaging equipment all require careful regulatory oversight before they reach patients. As medical technologies become more advanced, many countries face increasing pressure to carry out complex scientific reviews with limited technical expertise and resources.

The new framework encourages regulatory reliance, allowing authorities to make use of scientific assessments, inspections and regulatory decisions already completed by trusted regulators. Each authority continues to make its own final decision, though the process reduces repeated evaluations and makes more efficient use of available expertise.

WHO believes this approach can help countries approve high-quality medical devices more quickly while maintaining rigorous safety and performance standards.

Supporting stronger regulatory systems

Dr Rogério Gaspar, Director of WHO's Department of Regulation and Prequalification, said the transitional WHO Listed Authority programme represents an important step toward a more connected and efficient global regulatory system.

He noted that greater cooperation allows regulators to build on each other's work, helping countries use limited resources more effectively while improving access to safe and reliable medical devices. Strengthening regulatory systems, he added, ultimately helps protect public health and improve patient care.

Building a more efficient global system

WHO says the interim list provides greater clarity for regulators seeking reliable reference authorities when making approval decisions. The framework is expected to improve consistency in regulatory oversight, strengthen confidence in medical device evaluations and support faster access to essential health technologies worldwide.

As more regulatory authorities complete the full WHO assessment process, the interim list will continue to evolve until the permanent WHO Listed Authority system for medical devices is fully established.