. /.   WORLD TRADE  
ORGANIZATION  G/TBT/N/UKR/2 
16 September 2008 
 (08-4283) 
Committee on Technical Barriers to Trade Original:   English 
  
 
 
NOTIFICATION 
 
The following notification is being circ ulated in accordance with Article 10.6. 
 
1. Member to Agreement notifying:   UKRAINE
 
If applicable, name of local government involved (Articles 3.2 and 7.2):         
2. Agency responsible:   Ministry of Health (MOH) of Ukraine, the State Committee for 
Technical Regulation and Consumer Policy (DSSU) 
Name and address (including telephone and fax numbers, e-mail and web-site 
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 [   ], 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):   Active medical products 
which are implanted (ICS: 11.040.40) 
5. Title, number of pages and language(s) of the notified document:   “Technical 
Regulation on active medical products which are implanted” No. 621, implemented by 
Decree of Cabinet of Ministers of Ukraine, dated 9 July 2008. 
6. Description of content:   The proposed Technical Regulation establishes general 
requirements for active medical products, which are implanted, their safety & procedures of 
conformity assessment. Draft of Technical Regulation will implement, in accordance with those which already exist in international practice, terms and definitions, rules and 
mechanisms of regulation of elaboration, conformity assessment of the products and 
manufacturing, control, supervision by the aut horized institutions of conformity assessment 
in order to protect human health and envir onment. The draft of the Technical Regulation 
also defines rules for classifying active me dical products, gives the description of 
procedures for evaluating the conformity re quirements of the basic requirements and 
national standards and form of a declaration of conformity. 
7. Objective and rationale, including the na ture of urgent problems where applicable:  
The aim of the Decree is the approval of the Technical Regulation on the active medical 
products, which are implanted,  which will guarantee the provision of medical & health-
improving institutions, scientific & research institutions and popula tion of Ukraine with 
good quality, safe and effective medical pr oducts, reducing low-qua lity medical products, 
which are in market. 
8. Relevant documents:   The Technical Regulation meets the requirements of the Directive of 
European Council 90/385/ ЕEС, dated 20 June 1990. G/TBT/N/UKR/2 
Page 2  
 
  9. Proposed date of adoption:   
Proposed date of entry into force:   }2012 
10. Final date for comments:   - 
11. Texts available from:  National enquiry point [  X ] or address, telephone and fax 
numbers, e-mail and web-site addresses, if available of the other body:   
WTO National Enquiry Point & Information Processing Centre 
04655, Kyiv, Lvivska Square, 8 Tel:. 272 1578, Fax: 272 1147  
Email: ep@mfert.gov.ua 
 Internet address where the text is available: 
http://zakon.rada.gov.ua/cgi-bin/laws/main. cgi?nreg=621-2008-%EF (in Ukrainian)