G/TBT/N/KOR/856  
9 September 2019  
(19-5737) 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, Heungdeok -gu, Cheongju -si, 
Chungcheongbuk -do, 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 [   ], 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 "Medical Devices Act" (27 page(s), in Korean)  
6. Description of content:  The Ministry of Food and Drug Safety (MFDS) of the Republic 
of Korea is amending the "Medical Devices Act" as stated below:  
A. The amendments have clarified the ground for the revocation of designation of 
an institution as a training institution for medical devices quality managers.  
B. Items that are granted "conditional marketing approval" would be allowed to 
obtain "approval for change" in case of any changes in relevant information.  
C. Quality managers would no longer be entitled to serve as quality managers if they 
have not completed the training on latest standards and specifications of medical 
devices, quality control and safety control as required by the Medical Devices Act.  
D. Prior review of advertisements that the government used to be responsible for 
would b e conducted by an independent panel.  
7. Objective and rationale, including the nature of urgent problems where 
applicable:  The amendments aim to address the limitations found in operation of the 
Act. G/TBT/N/KOR/856  
 
- 2 - 
 
  8. Relevant documents:   
• MFDS NOTIFICATION No. 2019 -398, 21 August 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@kor ea.kr  
Website: http://www.knowtbt.kr  
https://members.wto.org/crnattachments/2019/TBT/KOR/19_4902_00_x.pdf