G/TBT/N/UKR/227  
13 September 2022  
(22-6746) Page: 1/2 
Committee on Technical Barriers to Trade  Original:  English  
 
  
NOTIFICATION  
The following notification is being circulated in accordance with Article 10.6  
 
1. Notifying Member:  UKRAINE  
If applicable, name of local government involved (Article 3.2 and 7.2):   
2. Agency responsible:   
Ministry of Health of Ukraine  
Name and address (including telephone and fax numbers , email and website 
addresses, if available) of agency or authority designated to handle comments 
regarding the notification shall be indicated if different from above:   
3. Notified under Article 2.9.2 [X], 2.10.1 [  ], 5.6.2 [X], 5.7.1 [  ], 3.2 [  ], 7.2 [  ], 
other :  
4. Products covered (HS or CCCN where applicable, otherwise national tariff 
heading. ICS numbers may be provided in addition, where applicable):  Medical 
devices, in vitro diagnostic medical devices, active implantable medical devices  
5. Title, number of pages and language(s) of the notified document:  Draft Resolution 
of the Cabinet of Ministers of Ukraine "On Amendments to Some Resolutions of the 
Cabinet of Ministers of Ukraine on the Recognition of Conformity Assessment Results"; (2 
page(s), in Ukrainian)  
6. Description of content:  At the beginning of Russia's military aggression against 
Ukraine, there was a risk of complicating the work of designated bo dies for conformity 
assessment of products with the requirements of technical regulations. The possible 
suspension of their work would have to a delay or blockage of imports to Ukraine of 
certain groups of goods that were subject to the conformity assessme nt procedure with 
the requirements of Ukrainian technical regulations with the involvement of designated 
conformity assessment bodies.  
Therefore, on March 29, 2022 the Resolution of the Cabinet of Ministers of Ukraine No 
389 "On Amendments to Some Resoluti ons of the Cabinet of Ministers of Ukraine on the 
Recognition of Conformity Assessment Results" was adopted providing for the possibility 
(for the duration of martial law) to recognize by a designated conformity assessment body 
of the results of conformity  assessment of medical devices, in vitro diagnostic medical 
devices and active implantable medical devices carried out by foreign accredited bodies 
(G/TBT/N/UKR/162/Add.1 ).  
To date, the majority of Ukrainian designated conformity assessment bodies have 
confirmed their ability to carry out conformity assessment activities and provide 
appropriate services to Ukrainian and foreign enterprises under martial law. Also, during 
the martial law period, the Ministry of Health of Ukraine has not received any applica tions 
from businesses about cases of inability of Ukrainian designated conformity assessment 
bodies to provide them with relevant services. Consequently, the Ukrainian infrastructure 
of designated conformity assessment bodies today continues to function an d is able to G/TBT/N/UKR/227  
 
- 2 - 
 
  provide business entities with the full range of services required to assess compliance 
with the requirements of technical regulations.  
In this regard, the draft Resolution of the Cabinet of Ministers of Ukraine "On Amendments 
to Some Resoluti ons of the Cabinet of Ministers of Ukraine on the Recognition of 
Conformity Assessment Results" was developed to exclude provisions allowing for the 
recognition by a designated conformity assessment body of the results of conformity 
assessment of medical d evices, in vitro diagnostic medical devices and active implantable 
medical devices carried out by foreign accredited conformity assessment bodies.  
7. Objective and rationale, including the nature of urgent problems where 
applicable:  Protection of human health or safety  
8. Relevant documents:   
Law of Ukraine "On Technical Regulation and Conformity Assessment", available in 
Ukrainian  
Technical Regulation on medical devices, approved by the Resolution of the Cabinet of 
Ministers of Ukraine of 02.10.2 013 No.753, available in Ukrainian  
Technical Regulation on in vitro diagnostic medical devices, approved by the Resolution 
of the Cabinet of Ministers of Ukraine of 02.10.2013 No.754, available in Ukrainian  
Technical Regulation on active implantable medica l devices, approved by the Resolution 
of the Cabinet of Ministers of Ukraine of 02.10.2013 No.755, available in Ukrainia  
9. Proposed date of adoption:  To be determined  
Proposed date of entry into force:  To be determined  
10. Final date for comments:  30 days from notification  
11. Texts available from:  National enquiry point [X] or address, telephone and fax 
numbers and email and website addresses, if available , of other body:   
https://moz.gov.ua/artic le/public -discussions/proekt -postanovi -kabinetu -ministriv -
ukraini -pro-vnesennja -zmin-do-dejakih -postanov -kabinetu -ministriv -ukraini --schodo -
viznannja -rezultativ -ocinki -vidpovidnosti  
https://members.wto.org/crnattachments/2022/TBT/UKR/22_6071_00_x.pdf