G/TBT/N/UKR/88  
 
22 February 2013  
(13-0944)  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 Economic Development and Trade of Ukraine 
Name and address (including telephon e 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 [   ], 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):  Measuring 
and control instruments and devices for functionality diagnostics: electrocardiographs; ultrasonic diagnostic devices; electroencephalograph, electrocardiographic monitors, equipment and devices for roentgenology. 
Instruments and apparatus for treatment. Anaesthetic apparatus. Devices for replacement 
functions of organs and systems, namely: devices for hemodialysis, electroconvulsive therapy, defibrillators, defibrillators-monitors, infant incubators. 
High-frequency and quantum devices for electrotherapy. Endoscopic equipment. 
 
Apparatus for ultrasound therapy. Apparatuses for inhalation anaesthesia. Apparatus for 
artificial respiration. Surgical tables with power. Dental equipment. Syringes. Surgical 
needles, reducing traumatic effects. Single us e injection needles. Cotton, bandages, gauze, 
and products made from them  
5. Title, number of pages and language(s) of the notified document:  Draft Order of 
the Ministry of the economic development and trade of Ukraine "On approval of 
amendments to the List of products subject to mandatory certification in Ukraine" (7 pages in Ukrainian language).     
6. Description of content:  Due to postponement of the date ("to third quarter of 2014") of 
mandatory use of the Technical Regulation on medical products, (according to the joint 
Order of the Ministry of the economic development and trade of Ukraine and the Ministry 
of health of Ukraine of 27 December 2012 No 1498/1126), there was taken a decision to 
add to the List of products subject to mandatory certification in Ukraine (initially approved 
by the Order of the State Committee for Technical Regulation and Consumer Policy of 
1 February 2005 No.28), the medical products indicated in item 4 of this notification above.  
7. Objective and rationale, including the nature of urgent problems where 
applicable:  The indicated in item 4 of this notification medical products, will be the 
subject of mandatory certification until the Technical Regulation on medical products is 
mandatory used (as indicated above - “third quarter of 2014”). The aim of the proposed 
measure is ensuring a proper monitoring mechanism for medical products safety and prevention of appearance of unsafe medical products on Ukrainian market.  G/TBT/N/UKR/88 
 
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  8. Relevant documents:    
- Order of the State Committee for Technical Regulation and Consumer Policy of 
1 February 2005 No.28; 
- Order of the Ministry of the economic development and trade of Ukraine and the 
Ministry of health of Ukraine of 27 December 2012 No 1498/1126; 
- Technical Regulation on medical products ap proved by the Decision of the Cabinet of 
Ministers of Ukraine of 11 June 2008 No 536 (notified under G/TBT/N/UKR/1). 
9. Proposed date of adoption:   
Proposed date of entry into force:    April 2013 
10. Final date for comments:  25 March 2013 
11. Text available from:  National enquiry point [X], or address, telephone and fax 
numbers, e-mail and web-site addresse s, if available of the other body:    
Internet address where the text is available: 
http://www.me.gov.ua/cont rol/uk/publish/article?ar t_id=197279&c at_id=32862