Health technology assessment of medical devices

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dc.coverageGeneva
dc.creatorWorld Health Organization
dc.date2025-05-28T09:45:04Z
dc.date2025-05-30T06:00:00Z
dc.date2025-05-28
dc.date.accessioned2026-08-03T10:21:23Z
dc.descriptionxii, 58 p.
dc.descriptionThis publication provides an updated overview of health technology assessment (HTA) for medical devices and its role in supporting evidence-informed decision-making within health systems. Developed as part of the WHO medical device technical series, the document examines the contribution of HTA to the selection, adoption, procurement, management and reassessment of medical devices in the context of universal health coverage. It describes the policy and governance frameworks supporting HTA, outlines the relationship between regulation, assessment and health technology management, and reviews global initiatives and WHO mandates related to medical devices and in vitro diagnostics. Particular attention is given to the needs and challenges of low- and middle-income countries, including capacity-building, governance, financing and data limitations. The document discusses methodological approaches for the assessment of medical devices, including rapid HTA, adaptive HTA, horizon scanning, multi-criteria decision analysis and the use of real-world data and evidence. It also addresses emerging topics such as digital health technologies, artificial intelligence, additive manufacturing and emergency preparedness. Emphasis is placed on stakeholder engagement, institutional collaboration and transparent decision-making processes to support equitable access to safe, effective and appropriate medical technologies.
dc.formatapplication/pdf
dc.identifier9789240110878 (electronic version)
dc.identifier9789240110885 (print version)
dc.identifierhttps://iris.who.int/handle/10665/381526
dc.identifier.urihttps://repo.dare.co.zw/handle/123456789/237723
dc.languageEnglish
dc.languageen
dc.publisherWorld Health Organization
dc.relationWHO medical device technical series;
dc.rightsCC BY-NC-SA 3.0 IGO
dc.rightshttps://creativecommons.org/licenses/by-nc-sa/3.0/igo
dc.rightsWorld Health Organization
dc.subjectTechnology Assessment, Biomedical
dc.subjectEquipment and Supplies
dc.subjectHealth Policy
dc.subjectUniversal Health Insurance
dc.subjectEvidence-Based Practice
dc.subjectHealth Services Needs and Demand
dc.subjectDecision Making
dc.subjectDecision Support Techniques
dc.subjectBiomedical Engineering
dc.subjectBiomedical Technology
dc.subjectDeveloping Countries
dc.subjectHealth Priorities
dc.subjectData Collection
dc.subjectArtificial Intelligence
dc.subjectPrinting, Three-Dimensional
dc.subjectTelemedicine
dc.subjectDigital Health
dc.subjectInternational Cooperation
dc.subjectStakeholder Participation
dc.subjectCost-Benefit Analysis
dc.subjectNeeds Assessment
dc.subjectHealth Services Accessibility
dc.titleHealth technology assessment of medical devices
dc.title2nd ed
dc.typePublications

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