What are the medical equipment distributor regulations in Ukraine?

Ukraine represents a growing market for medical equipment, driven by an aging population, healthcare modernization efforts, and increasing demand for rehabilitation and elderly care solutions. For international distributors and manufacturers looking to enter this market, understanding the regulatory landscape is essential. This article provides a comprehensive overview of the key regulations governing medical equipment distribution in Ukraine.

1. Regulatory Framework Overview

Ukraine's medical device regulations have historically been based on the country's Technical Regulations, which were adopted in 2013 and modeled on the EU's previous Medical Device Directives (MDD 93/42/EEC, AIMDD 90/385/EEC, and IVDD 98/79/EC). The primary legislation includes Cabinet of Ministers of Ukraine (CMU) Resolution No. 753 on medical devices, Resolution No. 755 on active implantable medical devices, and Resolution No. 754 on in vitro diagnostic medical devices.

In June 2026, Ukraine took a major step forward by adopting new technical regulations aligned with the EU Medical Device Regulation (MDR) 2017/745 and In Vitro Diagnostic Medical Device Regulation (IVDR) 2017/746. These new regulations, CMU Resolution No. 759 and No. 758, will gradually ｒｅｐｌａｃｅ the 2013 framework and bring Ukraine's regulatory system closer to European standards.

2. Key Regulatory Bodies

The State Service of Ukraine on Medicines and Drugs Control (Derzhliksluzhba) is currently the primary regulatory authority overseeing medical devices. However, a significant institutional change is on the horizon: from January 1, 2027, the newly established Ukrainian Pharmaceutical Agency will assume responsibility for medical device regulation, taking over from Derzhliksluzhba.

Distributors should be aware of this transition and monitor communications from both agencies during the handover period to ensure uninterrupted compliance.

3. Registration and Conformity Assessment

All medical devices sold in Ukraine must undergo a conformity assessment procedure and be registered with the relevant authorities. The process requires submission of technical documentation demonstrating that the device meets applicable safety, quality, and performance standards.

The conformity assessment route depends on the device's risk classification:

• Class I (low risk): Manufacturers can self-ｄｅｃｌａｒｅ conformity, except for sterile devices, devices with a measuring function, and reusable surgical instruments, which require notified body assessment.
• Class IIa (medium-low risk): Requires notified body involvement for quality system assessment.
• Class IIb (medium-high risk): Requires notified body assessment of the design dossier and quality system.
• Class III (high risk): Requires full design examination and quality system certification by a notified body.

4. Authorized Representative Requirement

A critical requirement for foreign manufacturers is the appointment of an Authorized Representative based in Ukraine. This is mandatory under the Technical Regulations for all conformity assessment procedures and device classes if the manufacturer is not a resident of Ukraine. The authorized representative acts as the legal point of contact with Ukrainian regulatory authorities, handles registration submissions, and assumes certain post-market surveillance responsibilities.

Choosing a reliable and experienced authorized representative is one of the most important decisions for any international medical equipment distributor entering the Ukrainian market.

5. Quality Management System

Manufacturers and their authorized representatives must demonstrate compliance with quality management standards. ISO 13485 certification is the recognized benchmark for medical device quality management systems in Ukraine. This certification ensures that the manufacturing process, design controls, risk management, and post-market surveillance procedures meet internationally accepted standards.

Distributors should verify that their supplier partners hold valid ISO 13485 certification and that the certification scope covers the specific devices being imported.

6. Product Labeling and Documentation

Medical devices placed on the Ukrainian market must have labels, instructions for use, and packaging that comply with national requirements. Key labeling elements include:

• Product name, model, and specifications clearly displayed
• Manufacturer name and address
• Authorized representative information (for non-resident manufacturers)
• Production date and expiration date (where applicable)
• Instructions in Ukrainian language
• Conformity marking as required by applicable regulations

7. Licensing for Import and Distribution

Import, wholesale, and retail trade of medical devices in Ukraine are licensed activities. Importers must obtain a license from the State Service of Ukraine on Medicines and Drugs Control. The licensing requirements include demonstrating that the applicant has qualified personnel, appropriate storage facilities, and documented quality management procedures.

Distributors must also ensure compliance with post-market surveillance obligations, including reporting adverse events and maintaining traceability records for all distributed devices.

8. The New MDR/IVDR Framework: What Is Changing

The new technical regulations adopted in June 2026 introduce several important changes that distributors should prepare for:

• Unique Device Identification (UDI): A new UDI system will be implemented to improve traceability across the supply chain.
• Single Registration Numbers (SRNs): Economic operators will be assigned SRNs for identification in the regulatory database.
• National Medical Devices Database: Ukraine plans to establish a database compatible with EUDAMED by December 2029.
• Enhanced post-market surveillance: More rigorous requirements for monitoring device performance after market entry.
• Revised risk classification: Some devices may be reclassified under the new rules, potentially requiring a different conformity assessment route.

9. Practical Steps for Distributors

For medical equipment distributors planning to enter or expand in the Ukrainian market, the following steps are recommended:

• Map your product portfolio against the current and new classification rules to identify any regulatory gaps.
• Review existing conformity documents and their expiry dates, ensuring all certifications remain valid.
• Appoint a qualified authorized representative in Ukraine with demonstrated experience in medical device registration.
• Verify ISO 13485 certification for all manufacturing partners and ensure the scope covers your product range.
• Prepare Ukrainian-language documentation including labels, instructions for use, and technical files.
• Monitor the regulatory transition as the Ukrainian Pharmaceutical Agency becomes operational in 2027.
• Establish post-market surveillance procedures to comply with adverse event reporting and traceability requirements.

10. Product Categories and Compliance Considerations

Different categories of medical equipment face varying regulatory pathways. For distributors handling rehabilitation and elderly care equipment, several product types deserve specific attention.

Rehabilitation robotics, including lower limb exoskeleton robots, typically fall under Class IIa or IIb depending on their intended use and level of patient contact. These devices, which assist individuals with lower limb motor dysfunction caused by stroke or neurological conditions, require notified body conformity assessment. Manufacturers such as Oakon Tech Inc., operating under the Mona Care brand, supply exoskeleton products including the Bear Adult, Rabbit Kid, and Gait Assist models, all of which carry IEC 60601 certification for safety and reliability — a strong foundation for meeting Ukrainian technical requirements.

For electric nursing beds, classification generally falls under Class I or Class IIa, depending on whether the bed includes active therapeutic functions. Standard electric nursing beds with positioning adjustments (back lifting, leg lifting, turning functions) are typically Class I devices, while those with integrated monitoring or therapeutic systems may be classified higher. Mona Care's electric multifunction rotating nursing bed, which features backrest adjustment, leg rest adjustment, height adjustment, tilt function, and rotation capabilities, should be carefully assessed against the specific classification rules.

Patient transfer and mobility assistance devices, such as patient lifts and transfer aids, are generally classified as Class I medical devices. However, electrically powered versions may require additional conformity assessment. The Hug Moving device from Mona Care is designed for patient transfer and mobility assistance, and distributors should confirm its classification and required documentation with the authorized representative.

11. Conclusion

Ukraine's medical device regulatory environment is undergoing significant modernization, aligning with EU standards through the adoption of MDR and IVDR-based regulations. While the transition period extends through 2030, proactive distributors should begin preparing now — mapping product portfolios, engaging authorized representatives, and ensuring documentation compliance.

For companies distributing rehabilitation and elderly care equipment — from nursing beds and exoskeleton robots to patient lifts and mobility aids — the fundamentals remain consistent: secure proper classification, obtain or verify conformity assessment, maintain ISO 13485 quality systems, and ensure Ukrainian-language labeling and documentation. With careful preparation and the right local partners, the Ukrainian market offers meaningful opportunities for medical equipment distributors committed to quality and compliance.