Competent authority
authority.competent-authority
Ministry of Health and State Service of Ukraine on Medicines and Drugs Control
Ministry of Health · structured requirements
🇺🇦 Ukraine medical device regulatory data
Explore the medical device requirements currently available for Ukraine, organized by topic and linked to official sources.
3 facts3 dimensions2 official sourceslatest verification 2026-08-13
Legal basis & guidance
Which current law, regulation, guidance, and transition provisions apply?
Official legal and guidance surface
legal-basis.official-surface
- Authority
Ministry of Health and State Service of Ukraine on Medicines and Drugs Control
- SubmissionSurface
Conformity-assessment and responsible-person notification model rather than a universal product-registration portal
- VerifiedHighlights
- The official FAQ maps device classes to conformity-assessment routes and responsible-person registration.
- Ukraine adopted new MDR/IVDR-aligned technical regulations in June 2026; effective dates and transition rules must be attached before tool use.
Registration pathways
Which registration, notification, listing, reliance, or conformity route applies?
Market-access route or official registration surface
registration.market-access-route
- SubmissionSurface
Conformity-assessment and responsible-person notification model rather than a universal product-registration portal
- VerifiedHighlights
- The official FAQ maps device classes to conformity-assessment routes and responsible-person registration.
- Ukraine adopted new MDR/IVDR-aligned technical regulations in June 2026; effective dates and transition rules must be attached before tool use.
Need to apply Ukraine's requirements to a product?
Confirm the current Ministry of Health pathway, evidence, and local-role details for the actual device before filing.