. /.  WORLD TRADE  
ORGANIZATION  G/TBT/N/KOR/78 
21 October 2004 
 (04-4480) 
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:   REPUBLIC OF KOREA
 
If applicable, name of local government involved (Articles 3.2 and 7.2):         
2. Agency responsible:   Korea Food and Drug Administration 
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 Devices 
5. Title, number of pages and langu age(s) of the notified document:   Proposed Draft 
Regulation for Reviewing Advertisement of  Medical Devices (10 pages, in Korean) 
6. Description of content:   The Proposed provisions are as follows: 
- establishing a provision for managing accredited organization that reviews 
advertisement of medical devices; 
- establishing a provision for applicants to submit the application form to the Review 
Organizations accredited by the Commissioner of KFDA. 
7. Objective and rationale, including the na ture of urgent problems where applicable:  
To protect consumers from false and/or exagge rated advertisements and establish a reliable 
market order. 
8. Relevant documents:   The Korea Food and Drug Administration Advance Notice No. 
2004-157 (4 October 2004), available in Korean only 
9. Proposed date of adoption:   
Proposed date of entry into force:   }November 2004 
10. Final date for comments:   15 November 2004 G/TBT/N/KOR/78 
Page 2  
 
11. Texts available from:  National enquiry point [    ] or address, telephone and fax 
numbers, e-mail and web-site addresses, if available of the other body:        
Documents are available from the Korea Food and Drug Administration website 
(www.kfda.go.kr
), and are also available from:  
International Trade and Legal Affairs Office  
Korea Food and Drug Administration  
5 Nokbun-dong, Eunpyung-Ku  
Seoul, 122-704 Republic of Korea  
 
Telephone: +82 2 380 1661  Telefax: +82 2 356 2893  
E-mail:  wtokfda@kfda.go.kr
  
 
 