  
  
G/TBT/N/KOR/861  
30 September 2019  
(19-6270) 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 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, Heun gdeok -gu, Cheongju -si, 
Chungcheongbukdo,  
Republic of Korea 28159  
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 Regulation of the Medical Devices Act" (28 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 Regulation of the Medical Devices A ct" as stated 
below:  
A.  When supply interruptions become predictable for essential medical devices for 
public healthcare, manufacturers and importers of the devices shall be mandated 
to report to the Minister of Food and Drug Safety.  
B.  An administrative disposition on false and misleading advertisement shall be 
introduced to regulate any actors engaging in marketing activities with 
exaggerated spoken language or performances trying to sell medical devices for 
purposes other than their origi nal purposes, approved by the MFDS.  
7. Objective and rationale, including the nature of urgent problems where 
applicable:  The amendments aim to promote reliable supply and safe management of 
medical devices.  G/TBT/N/KOR/861  
 
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  8. Relevant documents:   
• MFDS NOTIFICATION No. 2019 -406 (5 September 2019)  
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:   
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@korea.kr   
Website: http://www.knowtbt.kr  
https://members.wto.org/crnattachments/2019/TBT/KOR/19_5309_00_x.pdf  
 