DLS · Europe

Ukraine medical device regulatory resources

Every Ukraine dataset, comparison, and AI workpaper we maintain — one entry point for the whole market.

5 free resources23/25 topics with recordsAug 2026 fees reviewed

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Everything we track for Ukraine

Additional certification and licence checker

Check whether product features may trigger separate radio, electrical, metrology, radiation, import, or other Ukraine requirements.

Medical device regulation news

Follow recent Ministry of Health and State Service of Ukraine on Medicines and Drugs Control policy, guidance, safety, and compliance updates.

AI medical device classifier

Describe your device and get a preliminary SMDC risk class with official rule references.

Government registration fees

Check the current Ministry of Health position on device and IVD fees.

Registration timeline

The periods Ukraine's Technical Regulation actually fixes, and the MDR-aligned regime arriving in 2030.

Changes after registration

Explore questions and sources →

Common questions about changing a registered medical device in Ukraine. Each question separates published rules from details still awaiting verification.

Does changing a device brand name or logo require an update? →Specific rules awaiting verification
How do I update a manufacturer's name without changing the legal entity? →Specific rules awaiting verification
What changes when the manufacturer's office address changes? →Specific rules awaiting verification
Does a catalogue or reference code change affect registration or UDI? →Specific rules awaiting verification
Can a registration transfer to a different legal entity? →Specific rules awaiting verification
Can several changes be filed together? →Specific rules awaiting verification

Structured regulatory requirements

Explore all 42 source-linked facts →

23 of 25 research dimensions currently covered · 12 official sources · latest verification 2026-09-15

Market entry

D01

Authority & regime

Verified

Competent authority: State Service of Ukraine on Medicines and Drugs Control (Держлікслужба, DLS) is responsible for applying the medical device technical regulations, state market surveillance, and maintaining…
Market-surveillance designation under 2026 reform: CMU Resolutions 759/2026 and 758/2026 add medical devices and IVDs (with accessories) to the state market surveillance product list of CMU Resolution 1069/2016 under the responsibility of Д…

2 source-linked facts

Checked 2026-08-26

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D02

Legal basis & guidance

Verified

New medical devices technical regulation (2026): CMU Resolution No. 759 of 10.06.2026 approves a new EU MDR aligned Technical Regulation on medical devices; the resolution enters into force 18.12.2026, but the Regulation itself applies fr…
New IVD technical regulation (2026): CMU Resolution No. 758 of 10.06.2026 approves a new EU IVDR aligned Technical Regulation on IVDs; the resolution enters into force 16.12.2026, the Regulation applies from 31.12.2030 (points…

3 source-linked facts

Checked 2026-08-26

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D03

Device definition & scope

Verified

IVD scope and in-house exemption: TR 754 covers IVDs and their accessories (reagents, calibrators, control materials, kits, instruments for examining human samples); it does not apply to devices manufactured and used only w…
Medical device definition: A medical device (виріб медичного призначення) is any instrument, apparatus, device, software, material or other article intended for diagnosis, treatment, prevention in the human body and/…

2 source-linked facts

Checked 2026-08-26

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D04

Classification rules

Verified

Risk classes I, IIa, IIb and III under Technical Regulation 753 (Annex 2 rules 9-26).: Class I, Class IIa, Class IIb, Class III

1 maintained scheme · 3 related facts

Checked 2026-08-25

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D05

Registration pathways

Verified

Designated conformity assessment bodies: Conformity assessment for TR 753 is performed by 15 designated bodies listed by Держлікслужба (e.g. ДП «Укрметртестстандарт» UA.TR.001, ДП «Харківстандартметрологія» UA.TR.002, ТОВ «УКРМЕДС…
Conformity procedures per device class: Class III: design examination (Annex 3) or type examination (Annex 4) combined with production quality assurance (Annex 5) or product verification (Annex 6); class IIa/IIb: Annex 3/4 with A…

4 source-linked facts

Checked 2026-08-26

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D06

Reliance & recognition

Verified

Wartime recognition of foreign conformity assessment: During martial law, devices that do not meet the technical regulation requirements may be placed on the market and/or put into use if a Ukrainian designated body recognizes the results of c…

2 source-linked facts

Checked 2026-09-15

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D07

Economic-operator roles

Verified

Authorized representative for foreign manufacturers: A manufacturer that is not a resident of Ukraine must appoint one authorized representative (уповноважений представник) responsible for placing devices on the market; the representative mus…
Responsible person (register obligation): The persons responsible for placing devices on the market (manufacturers and their authorized representatives) are 'creators of register information' who must notify Держлікслужба of their…

2 source-linked facts

Checked 2026-08-26

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D08

Establishment, import & distribution

Verified

Import/border conformity controls: Держлікслужба and the customs authorities (органи доходів і зборів) jointly verify conformity marking at import: where marking is absent or defective the manufacturer/representative must br…

1 source-linked fact

Checked 2026-08-26

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D09

Dossier requirements

Verified

Technical documentation retention: The manufacturer must keep conformity assessment documentation for at least 5 years, and for implantable medical devices at least 15 years (Annex 3, point 16, TR 753).
Responsible-person notification documents: The notification to the Register must be supported by documents confirming the stated data; an authorized representative additionally submits the manufacturer's written mandate (power of at…

2 source-linked facts

Checked 2026-08-26

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D10

Official forms & portals

Verified

Electronic register submission: Notifications to the Register of responsible persons are submitted through the electronic user cabinet (hosted at drmvcitizen.moz.gov.ua, linked from dls.gov.ua) using a qualified electroni…

1 source-linked fact

Checked 2026-08-26

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Submission & evidence

D11

Label, IFU & language

Verified

Core label elements: Labels must carry the manufacturer's name/trademark and address, batch code or serial number where applicable, the date until safe use is guaranteed (year and month), and any special storag…
IFU exception for class I and IIa: Instructions for use are placed in the packaging of every medical device, but are not necessary for class I and class IIa devices that can be used safely without such instructions.

4 source-linked facts

Checked 2026-08-26

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D12

QMS, audit & inspection

Verified

Designated-body QMS audits: For quality system and product certificates (Annex 3), the designated body must periodically conduct checks and assessments to verify the approved quality system is applied (with a report t…

1 source-linked fact

Checked 2026-08-26

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D13

Standards, testing & ancillary approvals

Unresolved

TR 753 standards presumption and designated bodies: Electrical safety

1 maintained overlay

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D14

Fees

Verified

Responsible-person register notification: UAH 0

1 maintained fee line · 1 related fact

Checked 2026-08-26

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D15

Review clocks

Unresolved

Class I · Self-declaration under Annex 8: 0 days

1 maintained pathway

Checked 2026-08-29

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D16

Approval validity & renewal

Verified

Certificate validity five years: Decisions of designated bodies under Annexes 3, 4, 6 and 7 of TR 753 (and TR 754) are valid for five years and may be extended for subsequent five year periods at the applicant's request wi…
Register exclusion when certificate or declaration expires: A responsible person is excluded from the Register on grounds including expiry of the declaration/certificate of conformity, cessation of activity, non conforming devices, unreliable inform…

2 source-linked facts

Checked 2026-08-26

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Lifecycle & post-market

D17

Change control

Verified

Design changes require designated-body approval: Changes to an approved device design that may affect compliance with the technical regulation or the conditions of use of the certificate must be separately approved by the body that issued…
QMS significant-change notification: The manufacturer must inform the designated body in advance of any planned significant changes to the quality management system; the body evaluates the changes and sends a reasoned decision.

2 source-linked facts

Checked 2026-08-26

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D18

UDI, listing & traceability

Verified

UDI and national database under 2026 reform: The 2013 technical regulations contain no UDI requirement; Resolution 759/2026 introduces one: implementation plan items include creating the UDI system (December 2027), appointing UDI issu…

1 source-linked fact

Checked 2026-08-26

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D19

Clinical investigation & performance

Verified

Notification of completed clinical investigations: The manufacturer or its authorized representative must notify Держлікслужба about the completion of clinical investigations (with justification where they were terminated early) and keep th…
Clinical evaluation requirement: Conformity with the essential requirements must necessarily include clinical evaluation in accordance with Annex 10 to TR 753; for the relevant procedure the manufacturer applies the Annex…

2 source-linked facts

Checked 2026-08-26

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D20

Special access & derogation

Verified

Custom-made and clinical-investigation devices: Custom made devices follow the Annex 9 procedure with a manufacturer's statement instead of the standard modules, and devices intended for clinical investigations are exempt, together with…

1 source-linked fact

Checked 2026-08-26

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D21

Manufacturer PMS

Verified

Post-market experience analysis: In the application for design/system examination the manufacturer undertakes to systematically analyse experience gained from post market use of its devices and to ensure corrective measure…

1 source-linked fact

Checked 2026-08-26

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D22

Vigilance & incident reporting

Verified

Immediate incident notification to DLS: The manufacturer must immediately notify Держлікслужба of any malfunction or deterioration of characteristics and/or performance of a device, or inadequacy of the instructions, that could l…

1 source-linked fact

Checked 2026-08-26

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D23

Recall, FSCA & market surveillance

Verified

Restriction/ban and withdrawal measures: Where a marking or other violation is not remedied, Держлікслужба or the customs authorities take measures to restrict or prohibit placing the device on the market and must satisfy themselv…

1 source-linked fact

Checked 2026-08-26

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D24

Advertising, claims & promotion

Verified

Medical device advertising restrictions: Under Article 21 of the Law 'On Advertising', only devices/methods officially allowed for use in Ukraine may be advertised; ads must carry a consult a doctor warning and the text 'Самолікув…

1 source-linked fact

Checked 2026-08-26

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D25

Submission communications & appeal

Verified

Appeal deadlines and routes: Written/electronic appeals to Держлікслужба must be reviewed within one month (15 days for simple matters, absolute cap 45 days); a complaint against actions or inaction of a state body may…
Grounds for leaving register notification unconsidered: Держлікслужба may leave a register notification without consideration where it is submitted by an unauthorized person, lacks required data, contains data inconsistent with the attached docu…

2 source-linked facts

Checked 2026-08-26

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Government fees

Full fee schedule (1 lines) →

Ministry of Health registration fees in UAH · reviewed 2026-08-25

Fee line	Amount	Provenance
Responsible-person register notification	UAH 0	Verified

Registration timeline

Full registration timeline →

State Service of Ukraine on Medicines and Drug Control (DLS) review clocks and planning ranges · 4-class (I, IIa, IIb, III) — EU-aligned (Law 1207) classification

Class / pathway	Review clock	Planning total	Provenance
Class I(Self-declaration under Annex 8) §18 of the Technical Regulation: for a Class I device that is neither custom-made nor investigational, the manufacturer follows the Annex 8 procedure and draws up the declaration of conformity, and that alone lets the device be placed on the market — no body reviews it and no period runs CMU Resolution No. 759 of 10 June 2026 approves an MDR-aligned replacement regulation, but it is brought into effect only from 31 December 2030 (two paragraphs wait for EU accession), so Resolution 753/2013 still governs	0 days	2-4 months	Verified

Class / pathway

Review clock

Planning total

Provenance

Class I(Self-declaration under Annex 8)

§18 of the Technical Regulation: for a Class I device that is neither custom-made nor investigational, the manufacturer follows the Annex 8 procedure and draws up the declaration of conformity, and that alone lets the device be placed on the market — no body reviews it and no period runs

CMU Resolution No. 759 of 10 June 2026 approves an MDR-aligned replacement regulation, but it is brought into effect only from 31 December 2030 (two paragraphs wait for EU accession), so Resolution 753/2013 still governs

0 days

2-4 months

Verified