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Ministry of Health · Europe

Ukraine medical device regulatory resources

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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.

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Government registration fees

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Registration timeline

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

Structured regulatory requirements

Explore all 41 source-linked facts →

23 of 25 research dimensions currently covered · 12 official sources · latest verification 2026-08-29

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
Current technical regulations
Medical devices in Ukraine are governed by three CMU technical regulations of 02.10.2013: No. 753 (medical devices), No. 754 (IVD), No. 755 (active implantable), all in force in the edition…
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…
3 source-linked facts
Checked 2026-08-26
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D03

Device definition & scope

Verified
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/…
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…
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
Market-access route
Ukraine has no state product registration for devices: placing on the market requires conformity assessment under the technical regulation (manufacturer's declaration of conformity, with a…
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…
1 source-linked fact
Checked 2026-08-26
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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
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…
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).
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
Labelling language requirement
User information supplied by the manufacturer (label and IFU content per Annex 1) must comply with the Law of Ukraine 'On ensuring the functioning of Ukrainian as the state language', i.e.…
Authorized representative on imported device labels
For devices imported for placing on the Ukrainian market, the name and address of the authorized representative must additionally appear on the label, or outer packaging, or in the instruct…
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
Checked 2026-08-29
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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
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…
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…
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
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…
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…
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 lineAmountProvenance
Responsible-person register notificationUAH 0Verified

Registration timeline

Full registration timeline →

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

Class / pathwayReview clockPlanning totalProvenance
Class I(Self-declaration under Annex 8)0 days2-4 monthsVerified
  1. 1Pre-Submission Preparation(1-3 months)
  2. 2Application Submission(1-2 weeks)
  3. 3Administrative Review(2-4 weeks)
  4. 4Technical Evaluation(0 days)
  5. 5Registration Approval(1-2 weeks)
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