G/TBT/N/KOR/488  
 
7 May 2014  
(14-2822)  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 telephon e 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 
(http://www.mfds.go.kr ). Also available from:  
International Cooperation Office 
Ministry of Food and Drug Safety 187 Osongsaengmyeong2-ro,Osong-eup, Ch eongwon-gun, Chungcheongbuk-do, 
363-700 
Republic of Korea   Tel: (+82) 43719-1564 
Fax: (+82) 43-719-1550 
Email: wtokfda@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:  Proposed 
Amendment on "Enforcement Regulation of the Medical Device Act" (39 pages, available in 
Korean).     
6. Description of content:   
- Exempt the approval authorization for medical devices of emergency use when the 
Minister of the Ministry of Food and Drug  Safety recognizes the need for their use 
in treating serious or life-threatening diseases¡¤conditions or when there is no 
alternative. 
- Currently, medical devices that are the same as ones whose approval have been 
previously nullified are not allowed to be authorized for approval. The current 
amendment clarifies the definition of "same medical devices" to signify medical devices with the same intended use, me thod of use, manufacture process, and 
raw materials as those whose approval have been previously nullified. 
-
 Establish a regulation that mandates the designation of a Quality Management 
Representative for each factory, and define his/her scope of responsibility.  
- Define contents of education programs for Quality Management Representatives 
and enable medical device-related organizations to be responsible for such 
programs. G/TBT/N/KOR/488 
 
- 2 - 
 
  - Lessen prohibitive regulations so that clinical trials of low level risk no longer 
require the approval from the Minister of  t h e  M i n i s t r y  o f  F o o d  a n d  D r u g  S a f e t y  
(they would only require an IRB approval) in conducting a clinical trial. 
7. Objective and rationale, including the nature of urgent problems where 
applicable:   
- Seeking to facilitate the manufacture an d import of medical devices to protect 
public health from serious or  life threatening diseases. 
- Aiming to enhance effectiveness in controlling medical devices through the 
clarification of ambiguous phrases. 
- Aiming to further ensure quality management of medical devices by designating a 
Quality Management Representative whose qualification and responsibility are clearly defined. The Quality Management Representative is not allowed to have 
other responsibilities except that of quality management. 
- Seeking to facilitate clinical trials on In-vitro Diagnostic Reagents and medical 
devices with low level risk. The Medical Devices Act requires both approvals from 
the Minister of the Ministry of Food and Drug Safety and IRB. The proposed 
amendment allows clinical trials with low level risk to be conducted with just an IRB approval. 
8. Relevant documents:   MFDS NOTIFICATION No. 2014-88 (14 April 2014).  
9. Proposed date of adoption:   
Proposed date of entry into force:    To be determined  To be determined  
10. Final date for comments:  60 days from date of notification 
11. Text available from:  National enquiry point [X], or address, telephone and fax 
numbers, e-mail and web-site addresse s, if available of the other body:    
Technical Barriers to Trade(TBT) Division 
Korean Agency for Technology and Standards (KATS) 96 Gyoyukwongil, Gwacheon-si, Gyeonggi-do, Rep. of  Korea 427-716 
Tel.:  (+82) 2 509 7254/7255  Fax:  (+82) 2 509 7307 
E-mail:  tbt@kats.go.kr    Website:  http://www.knowtbt.kr  
http://members.wto.org/crnattach ments/2014/tbt/KOR/14_2243_00_x.pdf