  
  
G/TBT/N/KOR/1149  
12 June 2023  
(23-3982) 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 [  ], 3.2 [  ], 7.2 [  ], 
other :  
4. Products covered (HS or CCCN where applicable, otherwise national tariff 
heading. ICS numbers may be provided in addition, where applicable):  in vitro 
diagnostic medical device  
5. Title, number of pages and language(s) of the notified document:  Amendments to 
the Standards of in vitro diagnostic Medical Device Good Manufacturing Practices; (16 
page(s), in Korean)  
6. Description of content:  The proposed amendment to the Standards of in vitro 
diagnostic Medical Device Good Manufacturing Practices i s as follows:  
1) Complete transfer of KGMP audit authority to Korean private conformity assessment 
bodies for export -only in vitro diagnostic medical devices  
2) Modification of required dossier for documentation review  
3) Clarification of the KGMP audit pr ocedure  
4) Exemption of location change audit for in vitro diagnostic software manufacturers  
5) Improvement of required dossier for in vitro diagnostic software manufacturers  
7. Objective and rationale, including the nature of urgent problems where 
applic able:  Protection of human health or safety  G/TBT/N/KOR/1149  
 
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  8. Relevant documents:   
MFDS NOTIFICATION No. 2023 -254, 30 May 2023  
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, 
369-811 
Tel.: (+82) 43 870 5315 Fax: (+82) 43 870 5682  
E-mail: tbt@kats.go.kr  Website: http://www.knowtbt.kr  
https://members.wto.org/crnattachments/2023/TBT/KOR/23_10171_00_x.pdf  
 