. /.  WORLD TRADE  
ORGANIZATION   
G/TBT/N/UKR/1/Rev.1 
16 July 2012  
 ( 12-3826 ) 
Committee on Technical Barriers to Trade Original:   English 
  
 
NOTIFICATION 
 
Revision 
 
The following notification is being circ ulated in accordance with Article 10.6. 
 
1. Notifying Member:  UKRAINE 
If applicable, name of local government involved (Articles 3.2 and 7.2):     
2. Agency responsible:   Ministry of Health of Ukraine, the State Service for Medicinal 
Products  
Name and address (including telephone and fax numbers, e-mail and website addresses, 
if available) of  agency or authority designated to handle comments regarding the 
notification shall be indicated if different from above:    
Ministry of Economic Development and Trade of Ukraine 
12/2 M. Hrushevskoho str., Kyiv, 01008  Tel.:  +38044 596 68 39 Fax:  +38044281 95 34 
Email:  ep@me.gov.ua  
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 applicab le, otherwise national tariff heading.
ICS numbers may be provided in  addition, where applicable):   Medical devices  
5. Title, number of pages and language(s) of the notified document:  Draft Resolution of the 
Cabinet of Ministers of Ukraine "On Ame nding Technical Regulation No. 536 on medical 
devices approved by the Cabinet of Ministers of  Ukraine, dated 11 June 2008" (46 pages in 
Ukrainian).  
6. Description of content:  The draft sets requirements for safely use of medical devices, 
requirements for development and manufacture of medical devices, requirements for medical devices that are attached to the power sources or equipped with the sources of power, design 
and ecological characteristics of medical devices. 
This document determines medical devices with  measurement function and medical devices 
with the function of emission. 
The draft Technical Regulation defines inform ation that should be provided by producer, 
general requirements for producers, conformity assessment procedure, putting into the circulation and operation of medical devices produced on the order, peculiarities of putting 
into circulation and operation of the system, procedural complex and peculiarities of sterilization procedure, peculiarities of putti ng into circulation and operation of medical 
devices intended for clinical trials.  G/TBT/N/UKR/1/Rev.1 
Page 2  
 
  The following draft has also 7 annexes:  
- Comprehensive quality assurance; 
- Verification of type; - Verification of products; - Provision on production quality; - Provision on quality of products; 
- Internal production control;  
- Declaration of conformity.  
7. Objective and rationale, including the natu re of urgent problems where applicable:  
The aim of the Draft is to approximate Ukrainia n legislation with the Directive 2007/47/EC of 
the European Parliament and Council of 5 September 2007 amending Council Directive 
90/385/EEC on the approximation of the laws  of the Member States relating to active 
implantable medical devices, Council Directive 93/42/EEC concerning medical devices and Directive 98/8/EC concerning the placing of biocidal products on the market. 
8. Relevant documents:  Directive  2007/47/EC of the European Parliament and Council of 
5 September 2007 amending Council Directive 90/385/EEC on the approximation of the laws 
of the Member States relating to active implantable medical devices, Council Directive 93/42/EEC concerning medical devices and Directive 98/8/EC concerning the placing of biocidal products on the market 
Laws of Ukraine "On conformity assessment", "On standardization", "On accreditation of 
conformity assessment bodies", "On standards,  technical regulations and conformity 
assessment procedures" "On medical products", "On the general safety of non-food products", 
"On the State market surveillance and contro l of non-food products " (Ukrainian language) 
9. Proposed date of adoption:   
Proposed date of entry into force:    - 
1 January 2013 
10. Final date for comments:  60 days from notification 
11. Texts available from:  National enquiry point [X], or address, telephone or fax numbers, 
e-mail and web-site address, if available of the other body:    
Ministry of Economic Development and Trade of Ukraine  
12/2 M. Hrushevskoho str., Kyiv, 01008 Tel./Fax:  +38044 596 68 39 Email:  ep@me.gov.ua  (in Ukrainian) 
Internet address where the text is available: 
http://www.moz.gov.ua/ua/por tal/Pro_20120504_0.html  (in Ukrainian)