🇺🇦 Ukraine medical device regulatory data

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 'Самолікування може бути шкідливим для вашого здоров'я' occupying at least 15 percent of the ad area/duration; therapeutic-effect claims for hard-to-treat diseases, guaranteed effects, fear appeals, and participation of doctors or medical workers are prohibited; telesales are banned.

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 within a period agreed in the contract.

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 information, termination of the representative mandate, or written request.

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 the Register of persons responsible for placing devices on the market; the Ministry of Health approves the register procedure; the Ministry of Economy designates conformity assessment bodies.

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 Держлікслужба (new items 18-2 and 20-2).

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 the design-examination certificate; the approval is issued as a supplement to the certificate.

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.

IVDs are risk-structured via Annex 2 lists to TR 754: List A (blood-group ABO/Rhesus/anti-Kell reagents; HIV 1/2, HTLV I/II, hepatitis B/C/D markers; vCJD blood-screening tests), List B (anti-Duffy/anti-Kidd, irregular antibodies, rubella/toxoplasmosis, CMV, chlamydia, HLA, PSA marker, trisomy-21 risk, and self-testing blood-glucose meters); self-testing devices (self-control) are those intended by the manufacturer for home use; all other IVDs are 'general'.

Designated-body involvement thresholds (DLS FAQ): a designated body is required for class I with measuring function, all class IIa, IIb, III, all sterile devices, IVDs in List B and self-testing IVDs, IVDs in List A, and active implantables; NOT required for class I (non-sterile, non-measuring), general IVDs, custom-made devices and procedure packs/systems.

Axis

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

Classes

• Id

  i

  Label

  Class I

  Normalized Risk Level

  low

• Id

  iia

  Label

  Class IIa

  Normalized Risk Level

  medium

• Id

  iib

  Label

  Class IIb

  Normalized Risk Level

  high

• Id

  iii

  Label

  Class III

  Normalized Risk Level

  highest

Regulator

DLS

Notes

• TR 753 point 14: medical devices are divided into classes I, IIa, IIб and III; classification rules in Annex 2 (rules 9-26: non-invasive, invasive, active, special); criteria include invasiveness, duration of use, body contact, action on vital organs, energy source.
• Durations: temporary up to 60 min continuous use, short-term up to 30 days, long-term from 30 days.
• IVDs are structured via TR 754 Annex 2 lists (List A blood-group/transmissible-agent reagents; List B incl. self-testing blood-glucose meters) plus a self-testing category, not an A-D class axis.
• Designated body required for: class I with measuring function, all class IIa/IIb/III, all sterile devices, IVDs in List A/B and self-testing IVDs, and active implantables; not required for class I (non-sterile, non-measuring), general IVDs, custom-made devices and procedure packs/systems (DLS FAQ).

The manufacturer or its authorized representative must notify Держлікслужба about the completion of clinical investigations (with justification where they were terminated early) and keep the report per Annex 10 point 9, giving market-surveillance authorities access on request.

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 10 procedure and notifies Держлікслужба by a statement per Annex 10 point 2.

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 within a single healthcare institution or enterprise.

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/or support of those processes; software is explicitly within scope.

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).

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 attorney, agreement or contract); a certified power of attorney including declaration rights and the prescribed notification form (Annex 2 to MoH Order 122) are required.

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 must be a legal entity or individual entrepreneur that is a Ukraine resident or registered under Ukrainian law, with a documented mandate from the manufacturer.

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 location and provide a list and description of their devices for entry into the Register of responsible persons.

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 bring devices into conformity, and if the violation is not remedied the authorities take measures to restrict or prohibit placing the device on the market and ensure its withdrawal.

Maintaining the Register of responsible persons is financed from the state budget (and other legally permitted sources); MoH Order 122 prescribes no charge for submitting a notification to the Register.

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 storage and/or handling conditions.

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.

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 instructions for use, where the manufacturer is not a Ukraine resident.

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. effectively Ukrainian; correspondence and records under the conformity procedures are subject to the same law.

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 from 31.12.2030; it repeals Resolutions 753/2013 and 755/2013.

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 353-362 from 01.12.2029; subpoints 2-9 of point 27 from 31.12.2031); it repeals Resolution 754/2013.

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 of 30.11.2022 and all losing force on 31.12.2030.

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 measures where devices no longer comply.

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 electronic signature; the Register is public and accessible only via the official DLS website in the 'Ринковий нагляд' section, with API data exchange.

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 to the manufacturer) and may conduct additional unannounced on-site checks.

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 themselves that the device is withdrawn from circulation.

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 «УКРМЕДСЕРТ» UA.TR.099), appointed by orders of the Ministry of Economic Development and Trade / Ministry of Economy; applicants may choose any designated body.

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 Annex 5, 6 or 7 (with class-specific limitations on design verification); class I (non-sterile, non-measuring): internal production control (Annex 8) with self-declaration, no designated body; custom-made devices: Annex 9 procedure with a statement.

General IVDs (not in Annex 2 lists, not self-testing): internal production control with manufacturer's declaration (Annex 3); List A: Annex 4 or Annex 5+7; List B: Annex 4 or Annex 5 combined with Annex 6 or 7; performance-evaluation devices: manufacturer's statement per Annex 8; self-testing devices additionally require designated-body design verification.

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 designated-body certificate where the class requires it) plus notification of the responsible person to the DLS electronic Register; the mark of conformity is affixed by the manufacturer.

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 custom-made devices, from bearing the mark of conformity.

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 be filed under subordination with a higher body or official, without prejudice to court review.

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 documents, documents violate electronic-document formatting requirements, or required documents are missing; resubmission is possible after remedying deficiencies.

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 issuing organizations (December 2028) and a National Medical Devices Database of 7 electronic systems (registration of devices, UDI database, economic-operator registration, designated bodies and certificates, clinical investigations, vigilance and post-market surveillance, state market surveillance) due December 2029.

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 lead to the death of a consumer/user or a significant deterioration of their health, and of the reasons for systematic recall of devices of the same type.