G/TBT/N/KOR/1138  
24 April 2023  
(23-2916) 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).  
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 [  ], 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 partial 
amendments to the Regulation on medical device approval/report/review, etc.; (18 
page(s), in Korean)  
6. Description of content:  The proposed amendments to the Regulation on medical device 
approval/report/review, etc. is as follows:  
1) Recognition of real -world evidence wh en reviewing clinical trial data  
- For clinical trial data, human test data, theses and papers (class of medical device 1 and 
2) must be submitted. It is to prepare the basis for recognition of real -world evidence 
when reviewing clinical trial data dependi ng on the characteristics of medical devices such 
as rare and urgently needed medical devices.  
2) Introducing a custom classification procedure for newly developed medical devices 
such as digital health devices  G/TBT/N/KOR/1138  
 
- 2 - 
 
  - To support rapid commercialization of newly  developed medical devices by establishing 
a procedure for introducing custom classification procedure for newly developed medical 
devices such as digital health devices  
3) Preparation of grounds for multiple purposes description of combination medical 
devices according to its characteristics  
- In the case of combination medical devices, a single purpose of use is described when 
applying for permission, but in order to operate a flexible screening and rational system 
that reflects the characteristics of var ious combination medical devices, we are trying to 
prepare a basis for listing more than one purpose of use according to the characteristics.  
4) Easing double inspection when distributing used special medical equipment  
- For special medical equipment of wh ich safety and performance are regularly checked 
through quality control, the certificate of inspection is exempted when distributing used 
products.  
5) Expansion of expedited review including medical devices subject to production/import 
suspension reportin g 
- Subject of expedited review is expanded to include medical devices subject to 
production/import suspension reporting and public health crisis response medical devices 
to promote prompt response and public health in the event of supply/demand occurrence s 
such as production/import suspension  
6) Increase test report accreditation body for biosafety data  
- To expand citizens' choice by increasing the number of laboratory audit institutions 
designated by the Minister of Food and Drug Safety for biosafety data  
7) Minor change improvement  
- Revise usage methods and precautions according to re -evaluation results, change of 
appearance of components, etc.  
7. Objective and rationale, including the nature of urgent problems where 
applicable:  Protection  of human health or safety  
8. Relevant documents:   
MFDS NOTIFICATION No. 2023 -183, 14 April, 2023  
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, 
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/2023/TBT/KOR/23_9246_00_x.pdf