G/TBT/N/KOR/935  
17 November 2020  
(20-8235) 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 -1564 
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):  In-Vitro 
Diagnostic Medical Devices; Diagnostic or laboratory reagents on a backing, prepared 
diagnostic or laboratory reagents whether or not on a backing, and certified reference 
materi als (excl. compound diagnostic reagents designed to be administered to the 
patient, blood -grouping reagents, animal blood prepared for therapeutic, prophylactic or 
diagnostic uses and vaccines, toxins, cultures of micro -organisms and similar products) 
(HS 3822); Instruments and apparatus for physical or chemical analysis, or for measuring 
or checking viscosity, porosity, expansion, surface tension or the like, or for measuring 
or checking quantities of heat, sound or light, n.e.s (HS 902780)  
5. Title, numb er of pages and language(s) of the notified document:  Amendment of 
"Standards of In -Vitro Diagnostic Medical Devices Good Manufacturing Practices" 
(18 page(s), in Korean)  
6. Description of content:  Ministry of Food and Drug Safety of Republic of Korea is 
proposing to amend the "Standards of In -Vitro Diagnostic Medical Devices Good 
Manufacturing Practices". The main changes proposed are:  
For IVD GMP audits that are subject to documentation review only, there are two 
additional documents that are required to  be submitted.  
7. Objective and rationale, including the nature of urgent problems where 
applicable:  Protection of human health or safety  G/TBT/N/KOR/935  
 
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  8. Relevant documents:   
• Ministry of Food and Drug Safety Public Notice No.2020 -486 (9 November 2020)  
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 [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/2020/TBT/KOR/20_7077_00_x.pdf