   
  
G/TBT/N/KOR/830  
 
9 May 2019  
(19-3180) 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:  REPUBLIC OF KOREA   
If applicable, name of local government involved (Article 3.2 and 7.2):   
2. Agency responsible:  Ministry of Food and Drug Safety  
Name and address (including telephone 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:   
Documents are available from the Ministry of Food and Drug safety(MFDS) website 
(www.mf ds.go.kr). Also available from:  
International Cooperation Office  
Ministry of Food and Drug Safety  
187 Osongsaengmyeong2 -ro, Osong -eup, Heungdeok -gu, Cheongju -si, 
Chungcheongbuk -do, 28159  
Republic of Korea  
Tel: (+82) 43 719 -1564 
Fax: (+82) 43 -719-1550 
Email: wtokfda@korea.kr   
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):  Medical 
Devices  
5. Title, number of pages and language(s) of the notified document:  Establishment 
of "Regulation on Integrated Management of Medical Device Information" (7 page(s), in 
Korean)  
6. Description of content:  A list of required information and guidance for manufacturers 
or importers on how to insert data into the database "Integrated Medical Device 
Information System (IMDIS)"  
7. Objective and rationale, including the nature of urgent problems where 
applicable:  Protection of Human health or Safety (Improving public health by reinforcing 
safety management for invasive medical devices.)  
8. Relevant documents:   
• MFDS NOTIFICATION No. 2019 -163 (29 March 2018)  
9. Proposed date of adoption:  To be determined  
Proposed date of entry into force:  To be determined  G/TBT/N/KOR/830  
 
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  10. Final date for comments:  60 days from notification  
11. Texts available from:  National enquiry point [X] or address, telephone and fax 
numbers and email and website addresses, if available , of other body:   
Technical Barriers to Trade(TBT) Division  
Korean Agency for Technology and Standards (KATS)  
93, Isu -ro, Maengdong -myeon, Eumseong -gun, Chungcheongbuk -do, 27737 Republic of 
Korea  
Tel.: (+82) 43 870 5525  Fax: (+82) 43 870 5682  
E-mail: tbt@kats.go.kr   
website: http://www.knowtbt.kr  
https://members.wto.org/crnattachments/2019/TBT/KOR/ 19_2747_00_x.pdf  
 