  
  
G/TBT/N/KOR/989  
25 August 2021  
(21-6425) 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:   
International Cooperation Office  
Ministry of Food and Drug Safety  
187 Osongsaengmyeong2 -ro, Osong -eup, Heungdoek -gu Cheongju -si, 
Chungcheongbuk -do, 28159  
Republic of Korea  
Tel: (+82) 43 -719-1569 
Fax: (+82) 43 -719-1550 
Email: intmfds@korea.kr  
Website: www.mfds.go.kr  
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 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:  Amendment of 
"Placement and Management of Unique Device Identifiers on Medical Devices" (5 page(s), 
in Korean)  
6. Description of content:  Ministry of Food and Drug Safety of Republic of Korea 
is amending the "Placement and Management of Unique Device Identifiers on Medical 
Devices" as stated below:  
The revision of the Notifications intended that license h olders for manufacturing or 
importing medical devices shall place UDIs in human readable formats when they apply 
UDIs to medical devices using data matrix barcode on the package label or device itself.  
7. Objective and rationale, including the nature of urgent problems where 
applicable:  Consumer information, labelling  
8. Relevant documents:  MFDS Public  Notice No. 2021 -362 (26 July 2021)  
9. Proposed date of adoption:  To be determined  
Proposed date of entry into force:  To be determined  G/TBT/N/KOR/989  
 
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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:   
Korea WTO TBT Enquiry Point  
Technical Barriers to Trade (TBT) Division  
Korean Agency for Technology and Standards (KATS)  
93 Isu -ro Maengdong -myeon Eumseong -gun 
Chungchungbuk -do  
27737  
+(82) 43 870 5525  
+(82) 43 870 5682 (Fax)  
tbt@korea.kr  
http://www.knowtbt.kr  
 
https://members.wto.org/crnattachments/2021/TBT/KOR/21_5394_00_x.pdf  
 