The first seminar devoted to expanding the scope of health technology assessment (HTA), namely the introduction of HTA for medical devices in Ukraine, took place recently.
During the event, Center experts presented the regulatory framework and practical aspects of conducting state HTA. In particular, participants were informed of the amendments to the “Procedure for Conducting State Health Technology Assessment” (resolution of the Cabinet of Ministers of Ukraine of 25 March 2026 No. 358), as well as the provisions of the Guideline “State Health Technology Assessment of Medical Devices,” approved by the Ministry of Health of Ukraine in 2025.
Special attention was paid to the new guideline. Participants reviewed the main stages of HTA, the assessment of clinical effectiveness, safety and cost-effectiveness of the use of medical devices, as well as the role of real-world clinical practice data in the assessment process.
During the block devoted to the procedure for state HTA, experts of the SEC explained the procedure for submitting materials, the stages of the assessment, the deadlines for checking the compliance of submitted materials with the established requirements, and the mechanisms for eliminating deficiencies. Participants also received practical recommendations on preparing materials in accordance with the requirements of current legislation.
Окремо зупинилися на особливостях оцінки медичних виробів порівняно з лікарськими засобами. Йшлося про коротший життєвий цикл медичних виробів, їх постійне вдосконалення та оновлення, ширше використання даних реальної клінічної практики, особливості формування клінічної доказової бази, а також особливості економічного моделювання. Комплексно було розглянуто міжнародний досвід і сучасні європейські підходи до проведення ОМТ, в тому числі у контексті євроінтеграції України.
The speakers emphasized that health technology assessment is an important tool for introducing modern, well-founded solutions with evidence-confirmed effectiveness into practice. This approach makes it possible to assess not only the innovativeness of a product but also its real benefit for patients, its impact on treatment outcomes, and the feasibility of its use in the health care system.
The seminar was attended by applicants who are manufacturers of medical devices, as well as specialists involved in preparing applications and dossiers. The speakers were the Director of the Health Technology Assessment Department Oresta Piniazhko, Deputy Head of the Division for Economic Feasibility Assessment of Medical Technologies Marharyta Khmelovska, and expert of the Division for Economic Feasibility Assessment of Medical Technologies Alina Kyrychenko.
The seminar will contribute to a better understanding of the new regulatory requirements by stakeholders of the HTA process for medical devices, as well as to improving the quality of the evidence submitted for state health technology assessment in line with modern international approaches.
