G/TBT/N/KOR/1001  
22 October 2021  
(21-7984) 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:  Amendments to 
the "Enforcement Rule of the Medical Devices Act" (45 page(s), in Korean)  
6. Description of content:  The Ministry of Food and Drug Safety (MFDS) of the Republic 
of Korea is amending the "Enforcement Regulations of Medical Devices Act" as st ated 
below:  
1. The Medical Devices Act was revised and promulgated on July 20, 2021, to 
mandate the sealing of medical devices that may be contaminated from an 
opened or compromised package and to ban the sale of medical devices that are 
packaged in opened or unsealed containers. Accordingly, the Enforcement 
Regulations of the Medical Devices Act are to be revised to define the medical 
devices that shall be subject to package sealing as well as the sealing 
requirements.  
2. The Medical Devices Act was rev ised and promulgated on August 17, 2021, to 
replace the Re -examination system (for newly developed medical devices, etc) 
with the Post -Market Surveillance system (for newly developed medical devices, 
etc). Accordingly, the Enforcement Regulations of the Me dical Devices Act are to G/TBT/N/KOR/1001  
 
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  be revised to provide operational guidance and to define the medical devices 
that are exempt from post -market surveillance.  
7. Objective and rationale, including the nature of urgent problems where 
applicable:  Consumer information , labelling; Protection of human health or safety  
8. Relevant documents:   
MFDS NOTIFICATION No. 2021 -494 (14 Oct  2021)  
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/2021/TBT/KOR/21_6702_00_x.pdf