G/TBT/N/KOR/567  
 
16 March 2015  
(15-1489)  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 
Heungdeok-gu, Cheongju-si Chungcheongbuk-do, 363-700  
Republic of Korea   
Tel: (+82) 43 719-1564 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 applic able, 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 Rule of the Medical Device Act" (298 pages, available in Korean) 
6. Description of content: The main contents are as the following:  
 Change the manufacture business license to be issued per "company" as opposed 
to the current "manufacturing site"; 
 Introduce the certification/notification system for Class I and Class II devices: 
transfer the task duties of certification/notification to the Medical Device 
Information Technology Assistance Centre;  
 Mandate the submission of GMP certificate upon application for medical device 
approval and certification(currently, GMP certificates may be submitted after approval, but before marketing); 
 Clarify the scope of duties for technical document reviewing agencies; 
 Establish the legal basis to allow concurrent review & processing of medical device 
approval and New Health Technology Assessment (currently, medical device 
approval must be completed first before undergoing New Health Technology 
Assessment); 
 Unify the administrative channels for business owners in notifying closure or 
suspension of business to a single channel. G/TBT/N/KOR/567 
 
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  7. Objective and rationale, including the nature of urgent problems where applicable: 
Amend subordinate regulations in accordance with the amended "Medical Device Act" and improve the current regulatory system.  
8. Relevant documents:  MFDS Notification No. 2015-57 (5 March 2015) 
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: Nati onal 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 5525   
Fax: (+82) 43 870 5682 E-mail: tbt@kats.go.kr    
Website: http://www.knowtbt.kr   
https://members. wto.org/crnattachments/2 015/TBT/KOR/15_1223_00_x.pdf