Explore the IVD requirements currently available for Ukraine, organized by topic and linked to official sources.
Source-linked rules for common changes to a registered IVD. Read the scope and conditions with each rule; unverified details are listed separately.
A change to the registered brand name and a change to logo artwork can follow different rules. The legal manufacturer, device design and intended purpose remain the same.
A source-verified answer for this specific scenario is not yet published.
The same legal manufacturer changes its name, potentially alongside the device brand. A transfer to another legal entity is a separate question; permission to combine filings needs its own evidence.
A source-verified answer for this specific scenario is not yet published.
An office address change for the same legal entity, potentially alongside name and brand changes. This does not cover moving a factory or manufacturing site, and a combined filing cannot be assumed.
A source-verified answer for this specific scenario is not yet published.
Check which identifier actually changes. A commercial catalogue, REF or order code is not automatically a device model, registered identifier, GTIN or UDI-DI. Rules for one identifier do not establish the route for another.
A source-verified answer for this specific scenario is not yet published.
A real change of legal manufacturer, registration holder or owner. This differs from renaming the same entity; a change of local representative or importer alone does not establish a registration transfer route. Where other changes occur with the transfer, the exact combination and sequence need separate evidence.
A source-verified answer for this specific scenario is not yet published.
Changes to brand, manufacturer name, office address and reference codes may occur together, including with a real transfer to another legal manufacturer, registration holder or owner. Assess transfer with each single change, and transfer with brand plus reference, manufacturer name plus reference, or office address plus reference changes: seven transfer combinations in total. Evidence must establish the exact combination and the order of filings and approvals. These combinations and their sequence are not all verified by the rules below; a rule for one change does not prove that a single application, fee or review period covers the combination.
A source-verified answer for this specific scenario is not yet published.
What expires, what is retained periodically, and when must renewal start?
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.
· Effective until 2030-12-31
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.
· Effective until 2030-12-31
Is the product a device, IVD, accessory, software, or borderline product locally?
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.
· Effective until 2030-12-31
Which evidence, local deltas, formats, and signatures are required?
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.
DLS FAQ additionally lists: notification per Annex 2 (paper + WORD), certified manufacturer's power of attorney incl. declaration rights, optional declaration copy; copies certified per ДСТУ 4163:2020 п. 5.26.
Which manufacturer, representative, holder, applicant, importer, and distributor roles apply?
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.
· Effective until 2030-12-31
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.
TR basis: point 31 TR 753 / point 23 TR 754 (Держлікслужба maintains the Register; MoH approves the procedure).
What regulator fee applies to this class, route, event, and date?
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.
Under the 2026 reform, Resolution 759's implementation plan (item 19, due December 2026) foresees a procedure for charging for registration of manufacturers, authorized representatives and importers.
Which label and IFU elements, languages, symbols, and translation controls apply?
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.
· Effective until 2030-12-31
Which current law, regulation, guidance, and transition provisions apply?
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.
Effective from 2026-12-16
Points 194-195 enter into force from the day Ukraine acquires EU member-state status.
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.
· Effective until 2030-12-31
TR 754 expiry basis is 758-2026-п; TR 753/755 expiry basis is 759-2026-п.
Which current form, portal, account, and submission package must be used?
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.
Effective from 2023-01-25
DLS register page: «Доступ до Реєстру осіб надається лише через офіційний вебсайт Держлікслужби: dls.gov.ua, в розділі «Ринковий нагляд»»; «до 01.07.2023 встановлено перехідний період».
Which registration, notification, listing, reliance, or conformity route applies?
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.
Choice-of-body rule: TR 754 point 17 (applicants may apply to any body). Designating authority: Law 124-VIII Art. 7.
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.
· Effective until 2030-12-31
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.
· Effective until 2030-12-31
Baseline 'conformity-assessment and responsible-person notification model' confirmed with primary sources.
Which foreign decisions or evidence can be reused, with what effect and conditions?
Existing records include acceptance, restrictions and evidence reuse. The applicable product scope and conditions are preserved below; a reference does not by itself confer market access.
No linked record is currently maintained. This does not establish that a pathway is unavailable.
Regulatory reference
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 conformity assessment performed by foreign accredited bodies, in line with parts 1 and 3 of Article 45 of Law 124-VIII.
Prior approval / evidence record
FDA 510(k)/PMA
Yes
Usable as supporting technical evidence only. There is no recognition route for a US clearance and no published period to reduce.
None published
Maintained reference · planning ranges remain estimates · reviewed 2026-08-29
Regulatory reference
Ukraine requires conformity assessment to its technical regulations by Ukrainian designated bodies and recognises no foreign registration certificate. The martial-law derogation (Resolution 389 of 29 March 2022) only lets a Ukrainian designated body recognise results of conformity assessment performed by foreign accredited conformity-assessment bodies under Article 45(1) and (3) of Law 124-VIII, which requires an accreditation-body MLA link and a recognition agreement between the Ukrainian designated body and the foreign body. An NMPA registration certificate is a regulator's approval, not an accredited-body assessment result, and no arrangement with Chinese bodies is provided for or was found.
china
nmpa
China NMPA medical device registration certificate (Class II/III) or Class I filing record
ukraine
All classes (Technical Regulations 753, 754, 755)
No Reliance Route
none
Product Marketing
Yes
Yes
Effective from 2022-03-30
Source passage: 2-6. Установити, що на період воєнного стану введення в обіг та/або експлуатацію медичних виробів/систем медичних виробів/процедурних наборів, щодо яких не виконані вимоги Технічного регламенту, затвердженого цією постановою, дозволяється за умови визнання призначеним органом з оцінки відповідності результатів оцінки відповідності, проведеної іноземними акредитованими органами з оцінки відповідності, відповідно до вимог частин першої та третьої статті 45 Закону України «Про технічні регламенти та оцінку відповідності».
Prior approval / evidence record
CE Mark (EU MDR)
Yes
Ukraine still runs the old EU directives rather than MDR, and Law No. 1207 as amended for martial law lets a CE-marked device onto the market on that basis, so the CE certificate is the route rather than an accelerant. No provision puts a period on the conformity assessment either way.
None published
Maintained reference · planning ranges remain estimates · reviewed 2026-08-29
How are deficiencies answered, clocks handled, and decisions escalated or appealed?
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.
Conformity-assessment disputes: applicants may choose any designated body (TR 754 point 17).
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.
No maintained record.
These country-level records can cover multiple product types. Check each item's scope and conditions before applying a fee, pathway or licence to an IVD.
Ukraine
ukraine
UA
🇺🇦
State Service of Ukraine on Medicines and Drug Control
DLS
europe
3
4-class (I, IIa, IIb, III) — EU-aligned (Law 1207)
class-i
Class I
low
Self-declaration under Annex 8
0
0
days
official-verified
Технічний регламент щодо медичних виробів, approved by CMU Resolution No. 753 of 2 October 2013 (current version 30 November 2022) — §18 Class I declaration of conformity, §33 60-day clinical investigation notice, and the 210-day State Expert Centre opinion
https://zakon.rada.gov.ua/laws/show/753-2013-%D0%BF
2022-11-30
2026-08-29
2
4
months
No
No
Yes
CE Mark (EU MDR)
Yes
Ukraine still runs the old EU directives rather than MDR, and Law No. 1207 as amended for martial law lets a CE-marked device onto the market on that basis, so the CE certificate is the route rather than an accelerant. No provision puts a period on the conformity assessment either way.
None published
FDA 510(k)/PMA
Yes
Usable as supporting technical evidence only. There is no recognition route for a US clearance and no published period to reduce.
None published
Yes
Ukrainian Authorized Representative
No
Not accepted
5 years
2026-08-29
partially-verified
Технічний регламент щодо медичних виробів, approved by CMU Resolution No. 753 of 2 October 2013 (current version 30 November 2022) — §18 Class I declaration of conformity, §33 60-day clinical investigation notice, and the 210-day State Expert Centre opinion
https://zakon.rada.gov.ua/laws/show/753-2013-%D0%BF
2022-11-30
2026-08-29
CMU Resolution No. 759 of 10 June 2026 approving the new Технічний регламент щодо медичних виробів, which transposes EU MDR 2017/745 but is brought into effect only from 31 December 2030
https://zakon.rada.gov.ua/laws/show/759-2026-%D0%BF
2030-12-31
2026-08-29
2026-08-29
default
planning-template
Maintained planning steps and estimates, not verified regulator deadlines.
1
Pre-Submission Preparation
Gather technical documentation, quality management system (QMS) records, and clinical data required by DLS. Appoint a Ukrainian Authorized Representative.
1-3 months
📋
2
Application Submission
Submit complete registration dossier to DLS including device description, risk analysis, and testing reports.
1-2 weeks
📤
3
Administrative Review
DLS reviews application for completeness. May request additional documents or clarifications.
2-4 weeks
🔍
4
Technical Evaluation
In-depth technical assessment of device safety and performance. DLS may issue questions.
0 days
⚙️
5
Registration Approval
Upon successful review, DLS issues Ukraine market authorization certificate.
1-2 weeks
✅
These country-level records can cover multiple product types. Check each item's scope and conditions before applying a fee, pathway or licence to an IVD.
ukraine
Ukraine
UA
Ministry of Health
0
0
UAH
Yes
0
0
UAH
Yes
responsible-person-register-notification
Responsible-person register notification
UAH
0
UAH 0
Per notification
Maintaining the Register is financed from the state budget (MoH Order 122, Section I point 9).
exact-current
official-verified
https://zakon.rada.gov.ua/laws/show/z0317-17
Ukraine MoH Order 122: responsible-person register financed from the state budget
2026-08-25
2026-08-25
official-verified
Ukraine MoH Order 122: responsible-person register financed from the state budget
https://zakon.rada.gov.ua/laws/show/z0317-17
2026-08-25
2026-08-25
exact-current
Yes
These country-level records can cover multiple product types. Check each item's scope and conditions before applying a fee, pathway or licence to an IVD.
ukraine
Ukraine
low
tr-753-standards-presumption-and-designated-bodies
TR 753 standards presumption and designated bodies
Medical Electrical Safety
Mandatory Pre Market
Finished Device
DLS publishes, for Technical Regulations 753, 754 and 755, national-standard lists whose application provides presumption of conformity. DLS also publishes the register of designated conformity-assessment bodies for these technical regulations.
candidate
State Service of Ukraine on Medicines and Drugs Control (Держлікслужба)
technical regulation on medical devices — national standards presumption-of-conformity lists
https://www.dls.gov.ua/%D0%BC%D0%B5%D0%B4%D0%B8%D1%87%D0%BD%D1%96-%D0%B2%D0%B8%D1%80%D0%BE%D0%B1%D0%B8/%D1%82%D0%B5%D1%85%D0%BD%D1%96%D1%87%D0%BD%D1%96-%D1%80%D0%B5%D0%B3%D0%BB%D0%B0%D0%BC%D0%B5%D0%BD%D1%82%D0%B8/%D1%82%D0%B5%D1%85%D0%BD%D1%96%D1%87%D0%BD%D0%B8%D0%B9-%D1%80%D0%B5%D0%B3%D0%BB%D0%B0%D0%BC%D0%B5%D0%BD%D1%82-%D1%89%D0%BE%D0%B4%D0%BE-%D0%BC%D0%B5%D0%B4%D0%B8%D1%87%D0%BD%D0%B8%D1%85-%D0%B2%D0%B8
State Service of Ukraine on Medicines and Drugs Control (Держлікслужба)
designated conformity assessment bodies for TR 753 (UA.TR.001-153)
https://www.dls.gov.ua/print-article?pa=1849
