Dili [Timor-Leste], September 11 (ANI): The WHO South-East Asia Region today committed to improving equitable access to quality-assured and affordable medical devices, including in vitro diagnostics (IVDs) and assistive technologies through an integrated life-cycle approach, from planning and regulation to procurement, maintenance, replacement and safe decommissioning.
For the first time ever at a WHO Regional Committee, Member States discussed medical devices as a dedicated agenda item and adopted a resolution setting out concrete, time-bound actions to strengthen national systems for planning, regulating, procuring, managing and monitoring medical devices, IVDs and assistive technologies.
Moving from broad recommendations to implementation, Member States agreed to designate, by 2027, a national lead mechanism or focal unit for the life-cycle management of medical devices and IVDs, with clearly assigned responsibilities across relevant institutions. By 2028, countries will complete a national baseline assessment covering priority service and diagnostic gaps; essential diagnostics and medical-device lists; regulatory-system capacity; and the availability, location, functionality and maintenance status of priority equipment.
By 2030, countries will develop or update costed national implementation plans linking essential diagnostics and priority medical devices with clinical service packages, primary health care and referral pathways, universal health coverage benefit packages, annual budgets, procurement plans, workforce requirements and emergency preparedness.
The resolution calls for stronger national regulatory systems, including appropriate oversight of software and artificial intelligence used as medical devices, supported by WHO regulatory benchmarking and institutional development plans. It also promotes health technology assessment or proportionate evidence review to inform decisions on inclusion in benefit packages and public investment.
A comprehensive approach to equipment management will cover inventory, preventive maintenance, calibration where required, repairs, spare parts, user training, service records, replacement and safe decommissioning. Procurement will move beyond acquisition price alone, using performance-based specifications that consider quality, total cost of ownership, installation, consumables, warranties, maintenance, training, interoperability, cybersecurity, environmental considerations and continuity of supply.
The resolution places particular emphasis on access at primary and other appropriate levels of care, especially for rural, remote, island and underserved populations. Essential technologies are to be matched with trained personnel, adequate infrastructure, quality assurance, consumables, maintenance and sustainable financing.
Regional cooperation will be strengthened through the South-East Asia Regulatory Network (SEARN) and other relevant platforms, including regulatory reliance and work-sharing, safety-information exchange, training, standardised nomenclature and technical specifications, procurement learning and emergency preparedness.
The resolution also provides for the development and operationalisation of Regional Centres of Regulatory Excellence for medical devices and IVDs, alongside strengthened capacity in health technology management and biomedical engineering through training, mentorship and exchange of practical models.
Member States will also have the opportunity to collaborate voluntarily on pooled or coordinated procurement, forecasting, strategic reserves, local or regional production, technology transfer and emergency supply continuity, while promoting transparency, competition and equivalent quality standards.
WHO will develop, by 2027, a regional implementation framework covering governance, essential lists, allocation by level of care, regulation, procurement, maintenance, supply continuity, post-market surveillance, replacement and monitoring. WHO will also provide a standardised but adaptable baseline-assessment package, support regulatory benchmarking and institutional development, and facilitate regulatory reliance, work-sharing and cooperation through SEARN.
Implementation will be tracked through a limited national dashboard covering the availability of essential technologies, functionality of priority equipment, preventive maintenance, downtime, stock-outs of critical consumables, adverse-event and recall reporting, and geographic equity in access.
A regional monitoring framework will be established by 2028, with progress reports to the Regional Committee in 2028 and 2030, followed by a final report in 2032 with recommendations for the next phase.
The resolution builds on progress already made by Member States in developing National Essential Diagnostics Lists (NEDLs), essential medical-device lists and Assistive Products Lists, and in strengthening diagnostic services, equipment maintenance and health technology management.
The South-East Asia Region has the highest number of countries with NEDLs among all WHO regions. India was the first globally to develop NEDLs. Nepal was the third globally. Thailand was the first country in ASEAN, followed by Timor-Leste as the only second country in ASEAN to develop NEDLs. Myanmar and Maldives are now working on their NEDLs. (ANI)
WHO South-East Asia Region to improve access to medical devices, in vitro diagnostics and assistive technologies
