For the first time in Ukraine, a Guideline on state HTA for medical devices has been approved (MoH order of 21.11.2025 No. 1771). This is another step toward a system in which every healthcare decision is based on evidence, and patients gain access to the best innovative medical technologies.
Among the key developers of the Guideline are experts of the State Expert Center of the Ministry of Health of Ukraine led by Director Mykhailo Babenko. While developing the document, the Center's team studied the methodologies and guidelines of leading international organizations in the field – EUnetHTA, NICE (United Kingdom), AOTMiT (Poland), ICER (USA) – and adapted them to Ukrainian realities. As a result, the document reflects the modern global approach to health technology assessment.
Why is this important?
Ukraine is getting a new methodological standard for the assessment of medical devices – from specialized implants to complex software. This means:
- informed decisions on the effectiveness and cost-effectiveness of medical technologies;
- transparent rules for all market participants;
- orientation toward best European practices;
- improving the safety and quality of medical care for patients.
What does the new Guideline contain?
The document defines key principles and requirements for:
- preparing applications and dossiers for state HTA of medical devices;
- specifics of comparative assessment of clinical efficacy, safety and cost-effectiveness of medical devices;
- the format and content of the authorized body's conclusion based on the results of medical device assessment.
The guideline is advisory in nature and is a practical tool for stakeholders – applicants, developers, experts, medical institutions and all other interested parties.
State HTA is recommended for:
- medical devices of class IIb (medium-to-high-risk devices) and class III (high-risk devices);
- in vitro diagnostic medical devices of class D;
- active implantable medical devices;
- software of class IIb and III.
This applies to devices that are entering the Ukrainian market for the first time in their group and must undergo conformity assessment.
To carry out HTA, the Applicant submits to the Center:
- application;
- dossiers in paper and electronic form, prepared in accordance with the requirements of the Guideline.
What does the adoption of the HTA Guideline for medical devices mean for Ukraine?
Using HTA recommendations for medical devices in public decision-making means harmonizing Ukrainian procedures with European ones; the rational use of healthcare system resources; and the introduction of global standards of transparency and evidence-based practice.
The text of the Guideline can be found at the link https://surl.li/fqlfsv
The State Expert Center of the Ministry of Health of Ukraine expresses its gratitude for the support and assistance in developing the new HTA guideline to the team of the Ministry of Health of Ukraine and personally to the Minister Viktor Liashko, the members of the HTA Expert Committee of the State Expert Center of the Ministry of Health of Ukraine, and the international partners: NICE International (United Kingdom), the UK Department for Business and Trade, the scientific experts of the university hospital of Radboud University in the Netherlands, the U.S. international support project “Safe, Affordable, and Effective Medicines for Ukrainians” (SAFEMed), as well as personally Doctor of Medicine Rabia Sudzhu; Doctor of Pharmaceutical Sciences, Professor Olha Zaliska; Director of the Department of Healthcare Standards, Doctor of Pharmaceutical Sciences, Professor Kostiantyn Kosiachenko; Doctor of Medicine, Professor Krzysztof Landa, and other developers.
