G/TBT/N/KOR/1199  
16 February 2024  
(24-1403) 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 (MFDS)  
187 Osongsaengmyeong2 -ro, Osong -eup, Heungdoek -gu Cheongju -si, Chungch eongbuk -
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):  Medical 
Devices  
5. Title, number of pages and language(s) of the notified document:  Proposed 
amendments to the "Regulation on medical device group and class by group"; (32 
page(s), in Korean)  
6. Description of content:  The proposed amendments to the "Regulation on medical 
device group and class by group" is as follows:  
1) Establishment of the technology levels of autonomous driving electric wheelchair  
- Establishment of new standards to create a basis for classifying autonom ous driving 
electric wheelchairs, taking into account their place of use and technical functionalities 
such as location determination, map formation, route creation, etc.  
2) Establishment of new items  
- Establishment of 42 new items for medical devices to categorize those developed within 
the industry and formalize temporarily designated items  
3) Adjustment of the class of medical devices  G/TBT/N/KOR/1199  
 
- 2 - 
 
  - The class of 8 items was adjusted considering international harmonization and equity 
with other medical devices.  
4) Ch ange in item name (including English name) and definition.  
- Two item names or definitions were changed based on item subdivison and 
considerations regarding clinical use environments.  
7. Objective and rationale, including the nature of urgent problems where 
applicable:  Protection of human health or safety  
8. Relevant documents:   
MFDS NOTIFICATION No. 2024 -75, 7 February 2024  
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/2024/TBT/KOR/24_01539_00_x.pdf