G/TBT/N/UKR/167  
24 July 2020  
(20-5102) 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 [   ], 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 dia gnostic medical devices, active implantable medical devices  
5. Title, number of pages and language(s) of the notified document:  Draft Order of 
the Ministry of Health of Ukraine "On approval of the Procedure for putting into circulation 
and operation of ce rtain medical devices, in vitro diagnostic medical devices and active 
implantable medical devices, in respect of which the requirements of technical regulations 
are not fulfilled, but the use of which is necessary in the interests of health care" 
(9 page(s), in Ukrainian)  
6. Description of content:  The draft Order provides that certain medical devices, in vitro 
diagnostic devices and active implantable medical devices, in respect of which the 
requirements of technical regulations are not fulfilled, b ut the use of which is necessary in 
the interests of health care, may be put into circulation and operation without right of their 
sale in cases:  
- participation in international technical assistance programs;  
- emergency situation;  
- individual use and/or exploitation by individuals for the purpose of preserving their life 
and health;  
- medical support (medical application) of military servicemen and persons in the rank and 
file and commanding officers who execute tasks during the fulfilment the acti vity to ensure 
national security and defence during the military activities, emergency state, special 
period;  
- medical care for units of the armed forces of other states, which are admitted to the 
territory of Ukraine in accordance with the legislation;  
- humanitarian aid.  
7. Objective and rationale, including the nature of urgent problems where 
applicable:  Protection of human health or safety  G/TBT/N/UKR/167  
 
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  8. Relevant documents:   
• Technical Regulation on medical devices, approved by the Resolution of the Cabinet 
of Ministers of Ukraine of 02.10.2013 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  
• Technic al Regulation on active implantable medical devices, approved by the 
Resolution of the Cabinet of Ministers of Ukraine of 02.10.2013 No.755, available 
in Ukrainian  
9. Proposed date of adoption:  To be determined  
Proposed date of entry into force:  From the  date of its official publication  
10. Final date for comments:  60 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:   
The text is available at the official web -site of the Ministry of Health of Ukraine:  
https://moz.gov.ua/article/public -discussions/proekt -nakazu -ministerstva -ohoroni -
zdorovja -ukraini -pro-zatverdzhennja -porjadku -vvedennja -v-obig-ta-ekspluata ciju-
okremih -medichnih -virobiv -medichnih -virobiv -dlja-diagnostiki -in-vitro-ta-aktivnih -
medichnih -virobiv  
https://members.wto.org/crnattachments/2020/TBT/UKR/20_4485_00_x.p df 
https://members.wto.org/crnattachments/2020/TBT/UKR/20_4485_01_x.pdf