Ukraine DLS Medical Device Register Teardown: Germany-First Supply Map
A comprehensive data teardown of Ukraine's State Service on Medicines and Drugs Control (DLS) medical device register, analyzing source countries, conformity frameworks, and wartime rules.
Sourcing and Compliance in a Wartime Frontier Market
For MedTech regulatory affairs directors, compliance managers, and market-access strategists, Ukraine represents a unique and complex landscape. It is a nation in the midst of a historic defense and reconstruction effort, a formal candidate for European Union accession, and a market transitioning its entire regulatory structure to align with Western standards. Yet, navigating its regulatory framework requires looking past pre-war assumptions.
Scenario Question:
We are evaluating Ukraine for device market entry — what is actually registered, who supplies it, and which conformity framework applies?
Direct Answer:
Ukraine's State Service on Medicines and Drugs Control (DLS) Register of Medical Devices holds 582,902 unique device declarations as of June 2026. Germany is the single largest source country with 142,769 declarations (~24.5%), far exceeding China (60,202, 10.3%), domestic Ukrainian production (57,507, 9.9%), and the United States (46,179, 7.9%). The regulatory landscape remains split under the legacy EU directives: 77.5% of active declarations are registered under Technical Regulation 753 (general medical devices, mirroring EU MDD 93/42/EEC), 22.2% under TR 754 (in vitro diagnostics, mirroring EU IVDD 98/79/EC), and only 14 declarations under TR 755 (active implantables). The registry is heavily concentrated in surgical instruments and IVD consumables, driven by German precision instrument manufacturers and Sialkot-based Pakistani suppliers.
This teardown provides a comprehensive, data-driven analysis of Ukraine’s medical device register, trace the geographical and corporate patterns of its supply chain, map its legacy conformity frameworks to the modern European regulations, and detail the critical wartime flexibilities that currently govern imports under martial law.
How many medical devices are registered in Ukraine's DLS register, and how is it structured?
The Ukrainian State Register of Medical Devices is maintained by the State Service of Ukraine on Medicines and Drugs Control (DLS). Historically, the register was structured around generic manufacturer-level declarations, making it difficult to assess the actual volume of distinct product lines on the market. Under Ministry of Health (MoH) Order No. 2311 (adopted December 21, 2022, and launched in January 2023), the registry transitioned to a modernized electronic format. This system requires the registration of individual device-level entries, linked to the manufacturer's local Authorized Representative (AR).
As of the June 22, 2026 official export, the DLS Register contains 582,902 unique, active medical device declarations. This represents a massive catalog of clinical technologies, spanning basic consumables to advanced imaging systems.
Registry Architecture and Data Fields
Each record in the DLS electronic register contains several key administrative and technical fields:
- Registration ID / Notification Number: The unique tracking number assigned upon submission.
- Responsible Entity (Authorized Representative): The local Ukrainian legal entity responsible for placing the device on the market.
- Manufacturer Name & Country: The legal manufacturer and its originating jurisdiction.
- Technical Regulation (TR): The conformity framework under which the device is registered (TR 753, TR 754, or TR 755).
- Classifier Code (NK 024): The national nomenclature code, which is directly aligned with the Global Medical Device Nomenclature (GMDN) system.
- Declaration Date: The date the notification was officially processed and entered into the system.
The register is updated continuously as local representatives submit new declarations. Under current DLS rules, notifications are processed within 15 business days of a complete electronic submission, provided there are no deficiencies in the accompanying documentation.
Registry Structural Breakdown
The active registry is split among the three primary frameworks as follows:
- Technical Regulation 753 (General Medical Devices): 451,843 declarations (77.51%)
- Technical Regulation 754 (In Vitro Diagnostics): 129,418 declarations (22.20%)
- Technical Regulation 755 (Active Implantable Medical Devices): 14 declarations (0.01%)
- Total Active Registry: 582,902 declarations
Which countries supply the most registered medical devices to Ukraine?
A country-of-origin analysis of the DLS register reveals a highly concentrated supply map. While many emerging markets are dominated by low-cost commodity imports from China, Ukraine’s register exhibits a strong Western European and domestic presence. This distribution highlights the legacy integration of the Ukrainian healthcare system with European clinical standards and procurement channels.
The table below breaks down the top source countries for medical devices registered in Ukraine, based on the manufacturer's declared country of origin:
| Rank | Country of Origin | Active Declarations | Share of Register (%) | Sourcing Profile |
|---|---|---|---|---|
| 1 | Germany | 142,769 | 24.5% | Capital equipment, imaging, surgical instruments |
| 2 | China | 60,202 | 10.3% | IVD consumables, disposable PPE, active electronics |
| 3 | Ukraine | 57,507 | 9.9% | Local manufacturing, packaging, basic hospital supplies |
| 4 | United States | 46,179 | 7.9% | Orthopedic implants, high-end cardiovascular devices |
| 5 | Turkey | 27,947 | 4.8% | Nearshore surgical drapes, wound care, consumables |
| 6 | Pakistan | 25,816 | 4.4% | Surgical instruments (primarily Sialkot cluster) |
The top six source countries account for roughly 57% of all active declarations; the remainder is a long tail of European suppliers (notably Switzerland, Italy, and France, concentrated in precision implants, dental hardware, and laboratory reagents) and Asian suppliers (notably Japan, in endoscopy and diagnostic imaging).
Key Sourcing Trends:
- German Dominance: Germany is the undisputed leader in Ukraine's device registry, holding nearly a quarter of all active declarations. This is driven by large-scale listings from capital equipment manufacturers (such as Siemens Healthineers and Dräger) and dental and surgical instrument specialists.
- The Rise of China: Chinese manufacturers represent the second-largest segment. Their footprint is concentrated heavily in in vitro diagnostics (IVD) and high-volume clinical consumables, reflecting global purchasing patterns.
- Domestic Resilience: Local Ukrainian manufacturers account for 9.87% of active declarations. These listings focus primarily on basic hospital consumables, personal protective equipment, medical furniture, and specialized battlefield emergency kits.
- The Pakistan Surgical Corridor: Pakistan holds a prominent 4.43% share. This representation is almost entirely composed of reusable surgical instruments manufactured in the Sialkot industrial cluster, imported and distributed by local Ukrainian surgical supply houses.
What is the TR 753/754/755 framework, and how does it map to the EU directives?
Ukraine's medical device regulatory system is governed by a series of Technical Regulations (TR) adopted by the Cabinet of Ministers in Resolution No. 753, 754, and 755 on October 2, 2013. These regulations were designed to harmonize Ukraine's rules with the European Union's legacy directives. Because Ukraine has not yet adopted the modern EU Medical Device Regulation (MDR 2017/745) or In Vitro Diagnostic Regulation (IVDR 2017/746), the country continues to operate on the legacy European framework.
Technical Regulation Mapping to EU Directives
| Ukrainian Regulation | Scope | Equivalent EU Legislation | Registry Volume |
|---|---|---|---|
| Technical Regulation 753 | General Medical Devices (Class I, IIa, IIb, III) | Medical Device Directive (MDD 93/42/EEC) | 451,843 (77.51%) |
| Technical Regulation 754 | In Vitro Diagnostic Medical Devices (IVDs) | In Vitro Diagnostic Directive (IVDD 98/79/EC) | 129,418 (22.20%) |
| Technical Regulation 755 | Active Implantable Medical Devices (AIMDs) | Active Implantable Directive (AIMDD 90/385/EEC) | 14 (0.01%) |
1. Technical Regulation 753: General Medical Devices
- EU Mapping: Directly equivalent to the legacy EU Medical Device Directive (MDD 93/42/EEC).
- Scope: Covers all non-active implantable and non-IVD medical devices, ranging from Class I (low risk, such as bandages and reusable hand instruments) to Class IIa/IIb (moderate risk, such as dental fillings and infusion pumps) and Class III (high risk, such as cardiovascular catheters and joint replacements).
- Classification Rules: Ukraine maintains the classification rules outlined in Annex VIII of the EU MDD. For details on how these rules compare to modern European requirements, see the EU MDR classification rules (Annex VIII) guide.
2. Technical Regulation 754: In Vitro Diagnostic Medical Devices
- EU Mapping: Directly equivalent to the legacy EU In Vitro Diagnostic Medical Device Directive (IVDD 98/79/EC).
- Scope: Reagents, calibrators, control materials, test kits, and laboratory instruments used to examine specimens derived from the human body.
- Classification: Registered under the legacy IVDD categories (List A, List B, Self-Testing, and General IVD), rather than the modern IVDR Class A-D framework.
3. Technical Regulation 755: Active Implantable Medical Devices
- EU Mapping: Directly equivalent to the legacy EU Active Implantable Medical Device Directive (AIMDD 90/385/EEC).
- Scope: Active medical devices intended to be totally or partially introduced surgically or medically into the human body (such as pacemakers and implantable insulin pumps).
- Registry Context: The extremely low number of active declarations under TR 755 reflects the fact that most advanced active implantables are imported under special state procurement exemptions or specific wartime recognition procedures rather than the standard commercial registration path.
Detailed Conformity Assessment Routes in Ukraine
For Class I devices (non-sterile, non-measuring), the conformity assessment route is self-declaration. The local Authorized Representative compiles the technical documentation, signs a Declaration of Conformity, and registers it with the DLS database.
For higher-risk devices (Class I sterile/measuring, Class IIa, IIb, and III), a third-party audit by a Ukrainian conformity assessment body (CAB) is required. The manufacturer must choose one of the following primary routes:
- System Audit Route (full QMS audit under TR 753): The Ukrainian CAB performs an audit of the manufacturer's Quality Management System (QMS) under ISO 13485. This can be conducted onsite or, under recent wartime rules, via desktop audit with remote validation. If successful, the CAB issues a QMS certificate valid for 5 years, subject to annual surveillance audits.
- Batch Certification Route (type-test/batch route under TR 753): Rather than auditing the manufacturing facility, the CAB inspects and tests samples from a specific shipment (batch) imported into Ukraine. The resulting certificate of conformity is only valid for that specific batch, making this route suitable for one-off sales or low-volume capital equipment.
Which manufacturers and device categories dominate the Ukrainian register?
Analyzing the active registrations at the manufacturer level reveals the key corporate players supplying the Ukrainian healthcare system. While Western multinationals dominate high-value sectors, specialized dental and instrument manufacturers account for the largest sheer volume of declarations due to the diverse variety of individual part numbers required for clinical instruments.
The table below highlights the top manufacturers registered in the DLS database, grouped by their core product specialties:
| Manufacturer | Country of Origin | Active Declarations | Primary Product Category |
|---|---|---|---|
| Task LLC | Ukraine | 16,627 | Reusable surgical instruments, clinical drapes |
| Codent / Roland Köhler | Germany | 13,776 | Reusable dental hand instruments, burs, drills |
| Arthrex, Inc. | United States | 13,180 | Orthopedic implants, anchors, arthroscopy kits |
| Surgitech Instruments | Pakistan | 10,876 | Reusable surgical drapes, forceps, scalpel handles |
Structural Sourcing Clusters:
- German Dental and Surgical Instruments: Beyond Codent/Roland Köhler, the register’s next tier is dense with German precision-instrument houses — including Hermann Medizintechnik, Ulrich Storz, RZ Medizintechnik, and Rudolf Medical — which together represent the classic premium instrument cluster. Reusable instruments require individual declarations for every micro-variation in length, angle, and tip style, leading to thousands of registered SKU entries per manufacturer. (Manufacturer names are taken from the DLS register’s Ukrainian transliterations and may correspond to multiple legal entities.)
- US Orthopedics Sourcing: Arthrex’s presence (13,180 active declarations) represents the dominant US player in the registry. This volume reflects the registration of specialized orthopedic fixation plates, screws, bone anchors, and arthroscopic instruments used in reconstructive surgeries.
- The Pakistan Reusable Segment: Surgitech Instruments, representing the Sialkot cluster, provides the lower-cost counterpart to the German instrument makers. These reusable steel instruments are critical for general surgery departments in regional Ukrainian public hospitals.
Classifier Code (NK 024) and Product Mix
Every declaration in the register is tagged with an NK 024 classifier code — Ukraine's national nomenclature, which is aligned with the Global Medical Device Nomenclature (GMDN). Read alongside the source-country and manufacturer data above, the NK 024 tags make the register's product mix legible: it is dominated by reusable surgical and dental instruments (the source of Germany's and Pakistan's huge declaration counts, since each length, angle, and tip variant needs its own entry), IVD reagents and assay kits (the source of China's volume), and orthopedic fixation hardware (the source of the US/Arthrex volume). Capital imaging systems are present but represent a small share of declaration count even where their value share is high — a reminder that this register measures breadth of registered assortment, not sales value.
How has wartime martial law changed Ukraine's device conformity and import rules?
The ongoing war has forced the Ukrainian government to introduce temporary flexibilities to ensure the uninterrupted supply of medical equipment and consumables. These rules, introduced under martial law, run parallel to the standard Technical Regulation (TR) conformity assessment pathways.
The Standard Conformity Assessment Pathway
Under peacetime rules, placing a Class IIa, IIb, or III device on the market under TR 753/754 requires:
- Appointing a local Authorized Representative (AR): The AR must be a legal entity registered in Ukraine.
- Notified Body Review: A Ukrainian conformity assessment body (CAB) must audit the manufacturer's quality management system (QMS) under ISO 13485 and issue a conformity certificate.
- DLS Notification: The AR registers the conformity declaration in the DLS electronic database.
This process is analogous to the role of an EU authorized representative (EC Rep), requiring a formal mandate and a minimum record-retention period of 5 years (15 years for implantable devices).
Sourcing and Compliance Options under Martial Law
| Sourcing Route | Auditing Requirements | Validity | Target Products |
|---|---|---|---|
| Standard TR Pathway | QMS audit or batch test under TR 753 | 5 years | Commercial stock, standard supply chains |
| Resolution 389 Route | Desktop review / CE certificate recognition | Linked to CE certificate | EU-certified commercial imports |
| Direct MoH Exemption | Fully waived for state tenders | One-time entry | Battlefield kits, trauma hardware, NGO donations |
Wartime Parallel Import Pathways
To bypass the bottlenecks of local auditing during the conflict, the Cabinet of Ministers introduced two major regulatory flexibilities:
- Unilateral Recognition of CE Certificates (CMU Resolution No. 389): Adopted on March 29, 2022, this resolution allows Ukrainian conformity assessment bodies to recognize certificates issued by EU Notified Bodies without performing local audits or QMS inspections. If a manufacturer holds a valid EC Certificate under MDD 93/42/EEC or MDR 2017/745, the Ukrainian CAB can issue a Ukrainian conformity certificate based on a review of the EU technical file.
- State Procurement Exemptions (MoH Letter of February 25, 2022): For devices purchased directly by the Ministry of Health, military hospitals, or international humanitarian organizations, the requirement for standard conformity declarations is suspended. These devices can be imported and placed directly into service under emergency import permits, bypassing the DLS registry entirely.
For companies evaluating market entry, these wartime routes significantly reduce the time-to-market. However, they are temporary measures linked to the duration of martial law. Manufacturers must prepare to transition these temporary registrations to standard TR 753/754 conformities once the emergency measures are lifted.
Detailed Step-by-Step Registration Checklist (Standard TR 753 Pathway)
Foreign manufacturers entering Ukraine through the standard commercial pathway must complete the following steps:
- Select and Mandate local Authorized Representative (AR): Execute a formal AR Agreement detailing the product scope and regulatory duties.
- Compile Technical Documentation: Ensure files are structured per the GHTF summary format (equivalent to the EU Technical File). Document titles and key summaries must be translated into Ukrainian.
- Apply to Ukrainian CAB: Select a registered Conformity Assessment Body (e.g., Uni-Cert, Prom-Standart). Submit the QMS documentation and the product file.
- CAB Review and Audit:
- QMS Route: The CAB reviews the ISO 13485 QMS documentation and performs a remote or onsite audit.
- CE Recognition Route: The CAB reviews the valid EC certificate and signs an agreement recognizing the European audit results.
- Draft Declaration of Conformity: The AR drafts and signs the Ukrainian Declaration of Conformity referencing TR 753.
- DLS Electronic Registration: The AR submits the declaration and the CAB certificate to the DLS electronic database.
- Obtain DAR Registry Entry: Once verified (typically 15 business days), the product is listed in the public DLS Register, allowing customs clearance.
Frequently Asked Questions
Has Ukraine aligned its medical device rules with EU MDR yet?
No, Ukraine has not yet adopted the EU MDR (2017/745) or IVDR (2017/746) frameworks. The Ukrainian technical regulations (TR 753, 754, and 755) remain aligned with the legacy EU directives (MDD, IVDD, and AIMDD). While the Ministry of Health has drafted plans to transition to MDR-aligned regulations as part of its EU integration goals, no effective implementation date has been finalized. Manufacturers must continue to compile their Ukrainian registration dossiers using legacy directive formats.
Does a foreign manufacturer need an authorized representative in Ukraine?
Yes. Any foreign medical device manufacturer placing products on the Ukrainian market must appoint a local Authorized Representative (AR). The AR must be a physical person or legal entity registered in Ukraine. The AR acts as the primary liaison with the DLS, manages the registration notifications, and is legally responsible for the safety and compliance of the devices in Ukraine. This role is separate from commercial distributors, though a distributor can be appointed to act as the AR.
What is the NK 024 classifier code used for in the Ukrainian register?
The NK 024 classifier code is the national nomenclature code used to group and identify medical devices in the Ukrainian registry. It is based directly on the Global Medical Device Nomenclature (GMDN) system. Every declaration submitted to the DLS register must be linked to a specific NK 024 code, which helps the regulator monitor device safety, track adverse events, and manage public procurement tenders.
Strategic Summary for Market Access
Ukraine's medical device market is larger and more structurally organized than its wartime status suggests, with 582,902 active declarations in the DLS register. Sourcing is heavily anchored in European partners, with Germany leading the market.
For regulatory and commercial directors, the key takeaways are:
- Framework Alignment: Ensure technical files map to TR 753/754 (legacy EU MDD/IVDD) rather than assuming EU MDR compliance is accepted directly without a conversion step.
- Authorized Representative Selection: Partner with a dedicated local AR who can manage the electronic notification process and transition temporary wartime clearances to permanent registrations.
- Wartime Access: Leverage CE-certificate recognition pathways (Resolution 389) to expedite market entry for critical products, while maintaining a compliance path for post-war transition.
For comparison with other non-EU registration frameworks in the region, refer to the EAEU medical device registration guide. For a sibling registry analysis in Africa, see the Angola ARMED establishment registry teardown. For emergency import exemptions in the EU, review the EU MDR Article 59 national derogation guide.
Disclaimer: This analysis is based on data extracted from the State Service of Ukraine on Medicines and Drugs Control (DLS) Register of Medical Devices as of June 22, 2026. Sourcing, regulatory compliance, and import rules under martial law are subject to rapid change. Manufacturers should consult with qualified legal and regulatory advisors before making market-entry decisions.