WHO: Health technology assessment of medical devices, 2nd ed (2025)

Summary

The World Health Organization (WHO) has published a new edition of this guidance on health technology assessment (HTA) for medical devices. Health technology assessment (HTA) is described as ‘a well-recognised and methodologically robust evidence-based priority-setting process used to provide information on the safety, efficacy, quality, appropriateness, and cost-effectiveness of health technologies’.

This document ‘is intended to provide guidance to policy-makers, particularly those in low- and middle-income countries that are currently developing HTA capacity.’ The document describes ‘general concepts of HTA and points to best-practice resources to enable low- and middle-income countries to make consistent, transparent and informed decision-making on the adoption and use of medical devices to ensure clinical needs are met whilst delivering value to patients, healthcare providers, and the broader health system.’