World Health Organization · 2nd edition, 2025 · 58 pages
HTA methodology, governance and capacity-building guidance for policy-makers establishing evidence-based medical device assessment systems
- Issuer
- World Health Organization
- Edition
- 2nd edition, 2025
- Audience
- Policy-makers, health ministry officials, HTA agency staff, biomedical engineers, hospital administrators, regulators, and health technology managers
- Evidence
- Expert consensus by WHO Strategic and Technical Advisory Group on Medical Devices (STAG-MEDEV), narrative review of HTA literature 2000-2023, synthesis of national HTA experiences, public consultation with 27 organizations from multiple WHO regions
- Reviewed
- 23 Oct 2026 · GMJ
What this guideline says
GMJ summary
This second edition provides comprehensive guidance on health technology assessment (HTA) for medical devices, aimed at policy-makers in low- and middle-income countries (LMICs) establishing evidence-informed decision-making systems. HTA is defined as a multidisciplinary process that uses explicit methods to determine the value of a health technology at different points in its lifecycle, supporting equitable, efficient, high-quality health systems and universal health coverage (UHC).
The document describes how medical devices differ fundamentally from pharmaceuticals—requiring different HTA methodologies due to shorter product lifecycles, frequent incremental iterations, device-user interactions, learning curves, lower-quality clinical trial evidence, lack of appropriate comparators and blinding, and combination with surgical procedures. It emphasizes that HTA links three distinct health technology functions: regulatory approval for market access, policy for coverage/reimbursement, and health technology management from procurement to decommissioning.
Key guidance covers institutionalizing HTA (legal frameworks, national HTA committees, governance principles), stakeholder engagement (patients, clinicians, biomedical engineers, industry), HTA methods suitable for LMICs (rapid HTA, adaptive HTA, multi-criteria decision analysis, real-world evidence), special topics (digital health, artificial intelligence, 3D printing, emergency preparedness), and international collaboration networks (HTAi, INAHTA, RedETSA, HTAsiaLink, EU-HTAR). The document supports WHO mandates from WHA67.23 (2014) and subsequent resolutions urging Member States to establish HTA mechanisms for UHC.
Key points
For clinicians — doses and thresholds as stated in the guideline
- HTA should be institutionalized with legal mandate, national committee with defined terms of reference, transparent governance, and representation from clinicians, biomedical engineers, health economists, patients, and other stakeholders
- Medical devices require different HTA approaches than pharmaceuticals: consider device-user interaction, learning curves, infrastructure requirements, operating costs, incremental innovations, and use real-world evidence when clinical trial data are limited
- HTA committees should apply explicit criteria: burden of disease, clinical effectiveness, budget impact, cost-effectiveness (when appropriate), equity, ethics, organizational impact, and implementation feasibility
- LMICs can adapt HTA from WHO Priority Medical Device Lists and Essential in vitro Diagnostics (EDL) to local context, using simplified methodologies: rapid HTA (5-10 days for emergencies), multi-criteria decision analysis (MCDA), or adaptive HTA from similar health systems
- Procurement decisions should prioritize quality and safety first, then consider total cost of ownership (upfront cost, installation, training, maintenance, consumables, warranties) rather than accepting lowest tender price alone
- HTA capacity-building requires three levels: individual (training, skills), organizational (university partnerships, HTA agencies, hospital-based HTA units), and environmental (policy frameworks, political will, data infrastructure, international collaboration)
- Good governance requires five attributes: accountability (mandates, sanctions, reporting), transparency (public disclosure of decisions), participation (stakeholder forums, advisory committees), integrity (clear roles, predictable processes), and policy capacity aligned with resources
- For emergency preparedness (e.g., pandemics), HTA methodologies should be adapted using rapid or ultra-rapid reviews, rolling/living HTA updates, real-world evidence, and provisional approval processes while maintaining value-based assessment principles
Comparison of health technology regulation, assessment and management
Table extracted from the guideline
| Characteristics | Health technology regulation | Health technology assessment | Health technology management |
|---|---|---|---|
| Perspective | Market access: considerations include quality, safety, performance and efficacy | Population-level: considerations include efficacy, relative effectiveness, safety, patient-relevant outcomes, appropriateness (including ethics, social and legal issues) and accessibility | Local-level health facilities: considerations include needs analysis, procurement, affordability, training and alternative technologies towards quality of care |
| Requirement | Mandatory | National recommendation on complex technologies | Local implementation of recommended technologies |
| Role | Prevent harm | Maximize clinical and cost-effectiveness, value-based decision-making | Management across the lifecycle of the device, from adoption to decommissioning to enhance appropriate and safe use |
Source: World Health Organization, Health Technology Assessment of Medical Devices, 2nd edition. Reproduced in summary form.
What changed in this edition
Versus the previous edition
- Updated from 2011 first edition with expanded coverage of digital health technologies, artificial intelligence, and 3D printing (additive manufacturing)
- New sections on real-world data and real-world evidence, living HTA, adaptive HTA, and emergency preparedness (informed by COVID-19 pandemic experience)
- Incorporated findings from WHO Global Atlas of Medical Devices 2022 survey and WHO HTA Survey 2020/2021
- Added reference to WHO Medical Devices Information System (MeDevIS) database and standardized nomenclature (EMDN, GMDN) established via WHA75.25 (2022)
- Expanded guidance on international collaboration networks including EU Health Technology Assessment Regulation 2021/2282 (EU-HTAR) effective January 2025
- Strengthened emphasis on role of biomedical engineers in HTA, aligned with IFMBE HTA Division eLearning platform and training courses
From the guideline
Verbatim
“HTA is a multidisciplinary process that uses explicit methods to determine the value of a health technology at different points in its lifecycle. The purpose is to inform decision-making in order to promote an equitable, efficient, and high-quality health system.”
Editor’s perspective
Why this matters for Georgia and the region
Prof. Giorgi Pkhakadze, MD, MPH, PhD
Editor-in-Chief, Georgian Medical Journal · Chair, Public Health Institute of Georgia · WHO consultant, health and migration
As WHO consultant and Chair of Georgia's Public Health Institute, I emphasize that this guidance arrives at a critical juncture for Georgia and the South Caucasus region. Our UHC programme, now over a decade old, requires systematic HTA mechanisms to ensure sustainability and value from health investments, particularly for high-cost medical devices in cardiovascular disease, cancer, and diabetes—our leading causes of morbidity. The recommendation I would stress most to Georgian policy-makers is establishing a legally mandated national HTA committee with multidisciplinary representation including biomedical engineers, modeled on successful LMIC examples like Malaysia's MaHTAS or Brazil's CONITEC, and adapting WHO Priority Medical Device Lists to our local epidemiology and costs rather than conducting resource-intensive de novo assessments initially. The realistic implementation caveat for Georgia is that while we have demonstrated capacity for evidence-based policy through hepatitis C elimination and national immunization programmes, HTA institutionalization will require sustained political commitment beyond electoral cycles, investment in health economist and biomedical engineer training (currently limited domestically), strengthening of health information systems to capture real-world data, and careful stakeholder management to balance clinical autonomy, industry interests, and fiscal constraints—challenges that derailed previous health technology assessment initiatives in neighboring countries.
ORCID 0000-0001-7609-4515 · Perspective written for the GMJ Guidelines Library, 23 Oct 2026
Applicability
Georgia and the South Caucasus
Georgia introduced universal health coverage (UHC) in 2013 and has demonstrated capacity for evidence-based health technology policy through successful national programmes including hepatitis C elimination (since 2015) and rotavirus vaccine introduction (2013). For Georgia and South Caucasus countries to strengthen HTA capacity for medical devices, national programmes should consider: establishing a multidisciplinary HTA committee under the Ministry of Health with representation from the National Centre for Disease Control, Public Health Institute, regulatory authorities (Georgian Medical Products Agency), academic institutions (Tbilisi State Medical University), biomedical engineers, clinicians, and patient representatives; developing legal frameworks and procedural guidance adapted from the WHO model and regional partners (e.g., EU-HTAR given Georgia’s European integration path); investing in health information system infrastructure to capture real-world data from electronic health records and disease registries; training health economists and HTA methodologists through partnerships with established agencies (e.g., NICE, HAS, MaHTAS) and networks (HTAi, INAHTA); and prioritizing HTA for high-burden diseases (cardiovascular disease, cancer, diabetes) using WHO Priority Medical Device Lists as reference while adapting to local epidemiology, costs, and health system structure. Regional collaboration among Georgia, Armenia, and Azerbaijan through South Caucasus networks could share HTA capacity, avoid duplication, and pool procurement for economies of scale.
Questions this guideline answers
Quick answers
How does HTA for medical devices differ from HTA for pharmaceuticals?
Medical devices require different HTA methods because: (1) they often have multiple uses and short lifecycles with frequent incremental iterations; (2) clinical evidence is typically lower quality due to inability to randomize or blind, lack of appropriate comparators, and device-user interaction including learning curves; (3) devices may be combination products or depend on surgical procedures; (4) they require infrastructure and training; (5) direct impact on patient outcomes is harder to quantify, making cost-effectiveness analysis more difficult. Rapid HTA, multi-criteria decision analysis, budget impact analysis, and real-world evidence may be more appropriate than traditional systematic reviews and cost-per-QALY analyses.
What is the minimum structure needed to establish HTA capacity in a low-resource setting?
Start with: (1) political commitment and legal mandate from Ministry of Health; (2) a national HTA committee with multidisciplinary membership (clinicians, biomedical engineers, health economists, patients) and defined terms of reference; (3) transparent governance and procedural guidance; (4) capacity-building through partnerships with established HTA agencies and training of individuals in HTA methods; (5) adaptation of existing HTA reports and WHO Priority Medical Device Lists to local context rather than conducting full de novo assessments initially; (6) basic data infrastructure (registries, electronic health records, cost data). Countries can use simplified methodologies (rapid HTA, MCDA) before developing full systematic review capacity, and leverage international collaboration networks (HTAi, INAHTA, regional networks) to share resources and avoid duplication.
Should HTA be conducted at national or hospital level for medical devices?
Both levels serve different purposes and are complementary: National HTA informs reimbursement decisions, benefit package design for UHC, and population-level policy, requiring consideration of cost-effectiveness, equity, and budget impact across the health system. Hospital-based HTA (HB-HTA) addresses local procurement, technology acquisition, and implementation decisions, considering existing technologies, local budgets, staff expertise, and patient population characteristics. HB-HTA typically uses shortened timeframes, compares to current rather than ideal comparators, and considers budget impact rather than cost-effectiveness. For LMICs with limited national HTA capacity, a hybrid approach may be practical: national priority-setting for high-cost, high-impact technologies affecting UHC benefit packages, with hospital-level assessment for local procurement decisions, informed by biomedical engineers and clinical staff. Both levels should align with national health priorities to avoid fragmentation.
How can countries with limited data infrastructure conduct HTA for medical devices?
Countries can: (1) adapt HTA reports from similar health systems and contexts (adaptive HTA) rather than conducting full de novo assessments; (2) use WHO Priority Medical Device Lists and Essential in vitro Diagnostics (EDL) assessments as reference, adapting to local burden of disease, costs, and priorities; (3) employ multi-criteria decision analysis (MCDA) with explicit criteria (clinical need, burden of disease, safety, implementation feasibility) that do not require extensive local cost-effectiveness data; (4) leverage real-world evidence from administrative data, claims data, product registries, and mobile health technologies where available; (5) conduct rapid HTA reviews using streamlined methods when timely decisions are needed; (6) invest progressively in data infrastructure (electronic health records, registries) while using available data initially; (7) collaborate with international HTA networks to share evidence and avoid duplication; (8) involve biomedical engineers who can provide technical data on device costs, maintenance, infrastructure requirements, and operational impact. Start with priority technologies for high-burden diseases where even limited data can inform better decisions than no HTA.
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- Issuer
- World Health Organization
- Type
- Publication
- Edition
- 2nd edition, 2025
- Replaces
- Health technology assessment of medical devices, WHO Medical Device Technical Series, 2011
- Status
- Current
- Published
- 2025-08-20
- Languages
- English
- Scope
- Global guidance for establishing HTA systems for medical devices, with focus on low- and middle-income countries
- Audience
- Policy-makers, health ministry officials, HTA agency staff, biomedical engineers, hospital administrators, regulators, and health technology managers
- Pages
- 58
- Licence
- CC BY-NC-SA 3.0 IGO
- ISBN
- 978 92 4 011087 8
- Evidence
- Expert consensus by WHO Strategic and Technical Advisory Group on Medical Devices (STAG-MEDEV), narrative review of HTA literature 2000-2023, synthesis of national HTA experiences, public consultation with 27 organizations from multiple WHO regions
- Record history
- Created 23 Oct 2026 · updated 23 Oct 2026 · next check Apr 2027
World Health Organization. Health technology assessment of medical devices, second edition. Geneva: WHO; 2025. (WHO medical device technical series). Licence: CC BY-NC-SA 3.0 IGO.GMJ Guidelines Library records are original summaries written by the GMJ editorial team from the issuer’s published document and reviewed by a physician. They do not replace the full guideline. The document is the copyright of its issuer and is linked, not hosted. Spotted an error or a newer edition? Tell the Guidelines Desk.
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