Ukraine Medical Device Conformity Assessment and Certification
Manufacturers and exporters wishing to export medical devices to Ukraine must ensure that their products comply with the technical regulations and medical device legislation applicable in Ukraine.
In Ukraine, the system for placing medical devices on the market is based on conformity assessment procedures carried out according to the class and nature of the product.
For this reason, the terms “Ukraine Medical Device Registration Certificate” or “Ukraine Medical Device Certificate” used on the market are not, by themselves, an adequate description under current legislation.
What essentially matters is that the following process is carried out correctly for the product:
Product Class → Technical Regulation → Conformity Assessment → Technical File → Declaration / Certificate of Conformity → Placing on the Market in Ukraine
Medical Device Legislation in Ukraine
One of the basic regulations for medical devices in Ukraine is the Technical Regulation on Medical Devices approved by Resolution No. 753 of the Cabinet of Ministers dated 2 October 2013.
This regulation sets out the requirements for placing medical devices on the market and for conformity assessment processes. The current regulation is in force as of 2026 and, according to the official legislation, is expected to expire on 31 December 2030.
Ukraine is also bringing its medical device legislation further into line with the European Union approach. Ukraine's technical regulation system is generally built on alignment with EU requirements and conformity assessment principles.
What Is the Ukraine Medical Device Registration Certificate?
The process referred to on the market in the past as the “Ukraine Medical Device Registration Certificate” must today be addressed together with the product's conformity assessment under the technical regulation.
For a medical device to be placed on the market in Ukraine, the product must meet the requirements of the relevant technical regulation and the applicable conformity assessment procedure must be completed.
Depending on the class and risk level of the product, documents such as the following may be requested:
- Technical file,
- Product safety and performance information,
- Risk assessment,
- Clinical evaluation,
- Test reports,
- Label and instructions for use,
- Manufacturer's details,
- Conformity assessment documents,
- Declaration of Conformity
Is UkrSEPRO Required for Medical Devices?
No. Today it cannot be said that a UkrSEPRO certificate must automatically be obtained for a medical device.
Ukraine's old mandatory UkrSEPRO product certification system ended in 2018.
For this reason, the old practice for medical devices of “first UkrSEPRO, then a Ministry of Health registration certificate” is not the general rule of the current system.
Which conformity assessment procedure the product is subject to must be determined according to the relevant technical regulation.
What Is Examined in the Ukraine Medical Device Certification Process?
Depending on the nature and class of the medical device, the following information and documents may be assessed:
Product Information
- Product name
- Model / reference number
- Intended use
- Technical characteristics
- Product classification
Technical Documentation
- Technical file
- Product drawings
- Technical characteristics
- Production information
- Instructions for use
Safety and Performance
- Risk analysis
- Product safety
- Performance requirements
- Clinical evaluation
Test and Laboratory Reports
Depending on the nature of the product, electrical safety, biocompatibility, sterilisation, performance or other technical tests may be required.
Labelling
The product's label, packaging and instructions for use must comply with the requirements applicable in Ukraine.
Why Is the Medical Device Class Important?
The conformity assessment procedure to be applied in Ukraine may vary depending on the classification of the product.
Characteristics of the medical device such as the following may be important in classification:
- Intended use,
- Type of contact with the human body,
- Duration of use,
- Whether it is invasive,
- Whether it is active or passive,
- Whether it is sterile,
- Whether it has a measuring function
For this reason, correct classification of the product is a critical stage before starting the certification process.
Ukraine Medical Device Declaration of Conformity
Depending on the applicable conformity assessment procedure, the manufacturer may need to prepare a Declaration of Conformity.
The declaration is the document in which the manufacturer officially declares that the product meets the requirements of the relevant technical regulation.
Depending on the class of the product, a designated conformity assessment body may also need to be involved in the conformity assessment.
Authorised Conformity Assessment Body
For some medical devices the manufacturer's own declaration may be sufficient, while for some product classes a designated/authorised conformity assessment body must be involved in the process.
For this reason, before certification, the following should be checked:
Product class → Conformity assessment procedure → Body requirement
Medical Device Export Process to Ukraine
At Istanbul Certificate Office, we generally follow the stages below in medical device certification work:
1. Product Analysis
The technical characteristics and intended use of the medical device are examined.
2. Product Classification
The classification of the product under the relevant legislation is assessed.
3. Technical Regulation Check
The Ukrainian technical regulation the product is subject to is determined.
4. Technical File Review
The existing technical documents, test reports and manufacturer's documents are reviewed.
5. Identifying Missing Documents
The required tests, reports or technical documents are identified.
6. Conformity Assessment
The required conformity assessment procedure is applied according to the class of the product.
7. Declaration of Conformity / Certification
Once the required process has been completed, the relevant conformity documents are prepared.
8. Placing on the Market in Ukraine
The final steps required for the product to be placed on the Ukrainian market are completed.
Important Legislative Change in the 2026–2030 Period
Ukraine is bringing its medical device legislation closer to the European Union system.
In addition, a new technical regulation for in vitro diagnostic medical devices (IVD) was adopted in 2026. Regulation No. 758 dated 10 June 2026 will enter into force on 16 December 2026, and the main date of application of the new IVD technical regulation has been set as 31 December 2030. There are also transitional provisions for existing IVD documents.
For this reason, especially for medical devices and IVD products, planning the certification process according to current legislation is important.
Ukraine Medical Device Certification with Istanbul Certificate Office
Istanbul Certificate Office provides consultancy on conformity assessment and certification processes to manufacturers and exporters shipping medical devices from Türkiye to Ukraine.
The service covers:
- Preliminary assessment of Ukrainian medical device legislation,
- Product classification,
- Technical file check,
- Coordination of testing and laboratory processes,
- Coordination of the conformity assessment body process,
- Declaration of Conformity process,
- Label and technical documentation check,
- Certification consultancy for the process of placing on the market in Ukraine
Check your product's conformity status before exporting medical devices to Ukraine.
By sharing your product's name, model number, intended use, HS code, existing CE certificates, test reports and technical file information with us, you can request a preliminary review of the conformity assessment process required for Ukraine.
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