WHO South-East Asia Region Enhances Medical Device Access
The WHO commits to improving access to medical devices and diagnostics in the South-East Asia Region through a comprehensive life-cycle management approach.
Member States will establish national mechanisms for medical device management by 2027.
By 2030, countries are expected to develop national plans linking diagnostics with healthcare services.
The resolution emphasizes equitable access, especially for underserved populations.
The World Health Organization (WHO) South-East Asia Region has pledged to enhance equitable access to quality medical devices, including in vitro diagnostics (IVDs), through a comprehensive life-cycle management strategy. This commitment was made during a recent Regional Committee meeting, where member states discussed medical devices as a standalone agenda item for the first time. A resolution was adopted that outlines specific, time-bound actions aimed at strengthening national systems for the planning, regulation, procurement, and monitoring of medical devices and IVDs.
The resolution mandates that by 2027, each member state designates a national lead mechanism or focal unit responsible for the life-cycle management of medical devices and IVDs. This unit will have clearly defined responsibilities across various institutions. By 2028, countries are required to conduct a national baseline assessment that identifies priority service and diagnostic gaps, essential diagnostics, regulatory system capacities, and the status of priority medical equipment.
By 2030, member states are expected to formulate or revise costed national implementation plans that connect essential diagnostics and medical devices with clinical service packages, primary healthcare, and emergency preparedness. The resolution also calls for the enhancement of national regulatory systems, particularly concerning software and artificial intelligence used in medical devices. WHO will support these efforts through regulatory benchmarking and institutional development plans.
The resolution emphasizes the need for comprehensive equipment management, which includes inventory control, preventive maintenance, and user training. It advocates for procurement strategies that prioritize performance-based specifications over mere acquisition costs, ensuring quality and sustainability. Special attention is given to improving access for rural and underserved populations, ensuring that essential technologies are paired with trained personnel and adequate infrastructure.
To facilitate regional cooperation, the South-East Asia Regulatory Network (SEARN) will be strengthened, promoting shared resources and emergency preparedness. WHO plans to develop a regional implementation framework by 2027 to govern the allocation and regulation of essential technologies. Progress will be monitored through a national dashboard, with reports due in 2028 and 2030, culminating in a final report in 2032 that will outline recommendations for future initiatives. This resolution builds upon existing efforts by member states to enhance diagnostic services and health technology management, with several countries already developing National Essential Diagnostics Lists (NEDLs).
