G/TBT/N/UKR/207  
3 November 2021  
(21-8335) 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 diagno stic medical devices, active implantable medical devices  
5. Title, number of pages and language(s) of the notified document:  Draft Law of 
Ukraine "On Medical Devices" (9 page(s), in Ukrainian)  
6. Description of content:   the draft Law aims at:  
•  elimination of ambiguous interpretation of the norms regarding classification of 
medical devices;  
• reduction of the circulation of counterfeit medical devices;  
•  elimination of double proof of safety of medical devices (deregulation);  
•  regulation of advertising of medical devices;  
•  creation of legal grounds for the development of legal acts concerning clinical 
investigations and performance evaluation;  
•  determination of the legal grounds for taking market surveillance me asures for 
all medical devices, regardless of the method of placing on the market;  
•  simplification of the conformity assessment procedure through the use of 
remote audits.  
7. Objective and rationale, including the nature of urgent problems where 
applicabl e: The purpose of the adoption of the Law of Ukraine "On Medical Devices" is 
to eliminate aspects of the circulation of medical devices that are not regulated by current 
legislation of Ukraine.; Prevention of deceptive practices and consumer protection; 
Protection of human health or safety  G/TBT/N/UKR/207  
 
- 2 - 
 
  8. Relevant documents:   
The Law of Ukraine "On technical regulations and conformity assessment",  
The Law of Ukraine "On Ensuring Sanitary and Epidemic Welfare of the Population",  
The Law of Ukraine "On medicines",  
The Law of Ukraine "On advertising",  
Resolution of the Cabinet of Ministers of Ukraine N 753 of 02 October 2013 "On approval 
of the Technical Regulation on medical devices",  
Resolution of the Cabinet of Ministers of Ukraine N 754 of 02 October 2013 "On approval 
of the Technical Regulation on in vitro diagnostic medical devices",  
Resolution of the Cabinet of Ministers of Ukraine N 755 of 02 October 2013 "On approval 
of the Technical Regulation on active implantable medical devices".  
9. Proposed date of adoption:  To be determined  
Proposed date of entry into force:  To be determined  
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:   
https://moz.gov.ua/article/public -discussions/proek t-zakonu -ukraini -pro-medichni -
virobi