  
  
G/TBT/N/KOR/870  
16 December 2019  
(19-8694) 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 website 
(www.mfds.go.kr ). Also available from:  
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 -1564 
Fax: (+82) 43 -719-1550 
Email: intmfds@korea.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:  Enforcement 
Rules on the In -Vitro Diagnostic Devices Act (140 page(s), in Korean)  
6. Description of content:  The In -Vitro Diagnostic Devices Act, which is the primary 
legislation of the enforcement rules, was enacted in an aim to establish an independent 
IVD devices management system that is more in line with the characteristics of IVD 
devices.  
The enforcement rules were prepared accordingly prescribe the classification criteria and 
the procedures and methods for approval, certification and reports of in -vitro diagnostic 
medical devices needed to implement the Act.  
7. Objective and ratio nale, including the nature of urgent problems where 
applicable:  Adoption of Domestic regulation  
8. Relevant documents:   
• MFDSNOTIFICATION No. 2019 -533 (28 November 2019)  G/TBT/N/KOR/870  
 
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  9. Proposed date of adoption:  To be determined  
Proposed date of entry into force:  To be determined  
10. Final date for comments:  60 days from notification  
11. Texts available from:  National enquiry point [ ] 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, Republic of Korea, 
27737  
Tel.: (+82) 43 870 5525 Fax: (+82) 43 870 5682  
E-mail: tbt@kor ea.kr Website: http://www.knowtbt.kr  
https://members.wto.org/crnattachments/2019/TBT/KOR/19_7235_00_x.pdf  
 