Medical devices regulatory update: Ukraine, July 2023

We inform you of regulatory updates for medical devices in Ukraine:

• end of COVID quarantine results in cancelation of emergency authorizations and tax for certain medical devices;
• end of the transition period to e-Register for class I and in-vitro medical devices;
• extension of UA certificates issued through the recognition route till the end of 2027/28;
• recognition of MDR and IVDR EC certificates in Ukraine;
• update of the national classification of medical devices;
• we launched a CRO for medical devices in Ukraine.

 
End of COVID exemptions
Anti-COVID legal acts that allowed:

• import of certain medical devices with 0% VAT rate and without import duty,
• emergency authorizations from the Ministry of Health for certain medical devices that do not comply with requirements of Technical regulations,

became obsolete as of July 30, 2023 due to the end of the quarantine in Ukraine.

Humanitarian aid remains exempt from taxes and non-tariff regulatory measures. We have recently published an article on our website to facilitate the understanding of the humanitarian aid import process in Ukraine.

Electronic notification of class I and IVD devices
From July 1, 2023, the transition period for electronic submission to the Register of Responsible Persons for Placing Medical Devices (e-Register) has ended. Notifications can only be submitted electronically using the electronic signature of the person introducing the devices into circulation.

Please note that data transfer to the new platform could result in data loss or errors. We recommend verifying the information regarding your medical devices in the e-Registry to avoid any issues during customs clearance and circulation.

Extension of UA certificates issued through the recognition procedure
On March 15, 2023, the European Parliament extended the transition period for Regulation 2017/745 (MDR) that extended the validity of the existing MDD and AIMDD certificates:

• until December 31, 2027, for class III and IIb implantable devices,
• until December 31, 2028, for non-implantable class IIb devices, IIa, Is and Im medical devices.

EU notified bodies should confirm the validity and extension of EC certificates through separate decisions. In Ukraine, this allows obtaining new certificates or extending existing ones issued through the recognition procedure until December 31, 2027 / December 31, 2028.

The recognition procedure significantly facilitates access to medical devices that have undergone conformity assessment in the EU. It is a transparent, predictable, and cost-effective method of medical device conformity assessment in Ukraine.

Recognition of MDR and IVDR certificates in Ukraine
In 2019, changes were made to Article 45 of the Law “On Technical Regulations and Conformity Assessment”, which made it possible to recognize EU certificates issued under Regulations with higher requirements. This allows the recognition of EC certificates under Regulations 2017/745 (MDR) and 2017/746 (IVDR).

Recognition of MDR and IVDR certificates in Ukraine is carried out according to the conventional recognition procedure, but a number of particularities should be considered, such as change of classes and classification rules, verification of the identity of ER and GSP requirements, new requirements for technical documentation, labeling, post-marketing, etc.

The national classifier of medical devices
From June 15, 2023, the National Classifier NK 024:2023 entered into force, and the previous version of the Classifier NK 024:2019 became invalid.

Cratia launched a CRO for medical devices
We started a clinical research service focused on medical devices. To achieve the highest industry standards, we expanded our existing team of regulatory experts, safety and quality specialists with clinical trials specialists with more than twenty years of experience in studies in Ukraine and EU countries.

The advantages of conducting clinical research on medical devices in Ukraine are a significantly shorter time for obtaining regulatory approvals and recruiting patients compared to the EU and the USA. At the same time, the clinical research industry in Ukraine is developed and experienced due to years of thriving clinical trials of medicines. The regulatory requirements are transparent, the provisions of the WMA Declaration of Helsinki are mandatory, and the national standard ISO 14155 “Clinical investigation of medical devices for human subjects — Good clinical practice” is in force.

We are ready to conduct a full cycle of II-IV phases of clinical trials, from the development of a draft synopsis to the preparation of a final report. We hope that our knowledge and experience will help in the development and evaluation of medical device safety and clinical performance, including the demonstration of compliance with the MDR requirements.
 
Have any questions or want to know more? Contact us:
+38 044 364 33 55
+38 044 361 48 28
17-21 Baggovutivska str., 6th floor, 04107, Kyiv, Ukraine
info@cratia.ua