. /.   WORLD TRADE  
ORGANIZATION  G/TBT/N/UKR/3 
16 September 2008 
 (08-4284) 
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):   Medical products for 
laboratory diagnostics in vitro. At this time they aren’t attributing into a separate group of goods on the territory of Ukraine. Related to group “immunobiological drugs”  (ICS: 11.100.10). 
5. Title, number of pages and language(s) of the notified document:   “Technical 
Regulation on medical products for laboratory diagnostics in vitro” № 641, implemented by 
the Decree of Cabinet of Ministers of Ukraine,  dated 16 July 2008, (28 pages, in Ukrainian).
6. Description of content:   The proposed Technical Regulation establishes general 
requirements for medical products for labor atory diagnostics in vitro, their safety & 
procedures of conformity assessment. Draft of  Technical Regulation will implement, in 
accordance with those which alr eady exist in international pr actice, terms and definitions, 
rules and mechanisms of regulation of elabor ation, conformity assessment of the products 
and manufacturing, control, supervision by the authorized institutions of conformity assessment in order to protect human health and environment. The draft of the Technical 
Regulation also defines rules for classifying of medical products for laboratory diagnostics 
in vitro, gives the description of procedures for evaluating the conformity requirements 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:  
Adaptation of Ukrainian legislation to EU legi slation in part where it relates to safety of 
medical products for laboratory diagnostics in vitro and procedures of conformity 
assessment of products to EU legislative b ase. Assurance of providing medical & health-
improving institutions a nd population of Ukraine with good quality, safe and effective 
medical products for laboratory diagnostics in  vitro, reducing of low-quality medical 
products, which are in market. G/TBT/N/UKR/3 
Page 2  
 
  8. Relevant documents:   Technical Regulation meets the requirements of the European 
Council Directive 98/79/EC, dated 27 Octobe r 1998 "Medical products for diagnostics in 
vitro" (in English); Laws of Ukraine "On conformity assessment" (2406-14), "On 
standardization" (2408-14 ), "On the accreditation of conformity assessment bodies“ (2407-14), "On standards, technical regulati ons and conformity assessment procedures" 
(3164-15), "On medicines" (123/96-VR), the Decrees of  the Cabinet of Ministers of 
Ukraine N 59 "On approval of the Procedure of the appointment of conformity assessment of products, processes and services, the require ments of technical regulations", dated 
24 January 2007, N 1599 "On approval of the description and rules of the national mark of 
conformity", dated 29 November 2001, N 1585 "O n approval of the Technical Regulations 
of assessment’s modules and labelling requirement s for national mark of conformity, which 
are used in technical regulations" dated 7 October 2003, N 73 “On approval of Provision on 
conformity control of immunobiological drugs, which are used in medical practice”, dated 
15 January 1996, the Order of Ministry of Health of Ukraine  № 393, “On List of products 
of medical purpose, which are subject to registration in Ukraine” dated 4 August 2005 and 
more then 25 standards and methodic instructi ons of quality control of medical products for 
diagnostics in vitro. 
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=641-2008-%EF (in Ukrainian)