Ukraine Approves First National HTA Guidelines for Medical Devices

In a major regulatory development, Ukraine’s Ministry of Health officially approved the Guidelines on Health Technology Assessment (HTA) for Medical Devices (Order No. 1771) on 21 November 2025. This marks the first time Ukraine has adopted a dedicated methodological framework for HTA of medical devices, enabling practical implementation of policy mandates that were previously difficult to operationalise.

Health Technology Assessment is an evidence-based evaluation process that supports informed decision-making on the adoption, pricing, reimbursement, and public procurement of health technologies, including medical devices. While HTA has long been included in Ukraine’s healthcare legislation, the absence of detailed methodological guidance limited its use, particularly for devices beyond pharmaceuticals. The new HTA Guidelines fill this gap and set out clear expectations for evidence generation, dossier structure, and assessment criteria that align with international best practices.

New HTA Framework: What It Covers

The Guidelines introduce a structured methodology for the state HTA of medical devices, covering several key categories:

• Medium-high risk medical devices (equivalent to Class IIb)

• High-risk medical devices (Class III)

• Class D in vitro diagnostic devices

• Active implantable devices

• Medical device software with higher risk profiles, such as Class IIb and III systems.

Under the new framework, manufacturers and authorised representatives must prepare HTA dossiers that demonstrate the clinical effectiveness, safety, and cost-effectiveness of their technologies. These dossiers will be reviewed by Ukraine’s authorised HTA body, the State Expert Centre of the Ministry of Health, which will issue draft HTA conclusions, facilitate applicant consultations, and publish a non-confidential version of the assessment.

Why This Matters for Industry Stakeholders

The introduction of these Guidelines represents a foundational shift in how medical devices are evaluated in Ukraine, with several important implications:

• Evidence-based decisions: HTA conclusions will support transparent, objective decisions on public procurement, reimbursement and market access.

• Alignment with EU practice: The methodology draws on international standards, reflecting principles from organisations such as EUnetHTA, NICE (UK), AOTMiT (Poland) and ICER (USA).

• Market predictability: Clear HTA expectations reduce uncertainty for manufacturers and help improve planning for new product entries and pricing strategies.

• Patient outcomes: A more robust, clinical evidence-driven market access system can support safer, more effective device utilisation across Ukraine’s healthcare system.

This development aligns with Ukraine’s broader regulatory reforms, including ongoing work to modernise medical device technical regulations in line with European Union MDR/IVDR frameworks. As Ukraine progresses toward deeper harmonisation with EU standards, the establishment of a functional HTA process strengthens both regulatory rigor and health system transparency.

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Looking Ahead

The new HTA Guidelines establish a practical foundation for device evaluation that will now be operationalised through regulatory and procurement mechanisms. Manufacturers and authorised representatives targeting the Ukrainian market should familiarise themselves with the HTA methodology and ensure their evidence generation strategies align with the new requirements.

As the Ukrainian regulatory environment continues to evolve, this milestone reflects a growing commitment to evidence-based healthcare decision-making and stronger alignment with international regulatory norms.

Source: Ukraine Ministry of Health National HTA Guidelines for Medical Devices (Order No. 1771, 21 November 2025)