G/TBT/N/KOR/559
19 February 2015 
(15-1003)  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 
Heungdoek-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: Amendment of 
"Regulations on Approval, Notification and Re view of the Medical Devices" (66 pages, in 
Korean)  
6. Description of content: 
• Designate medical devices subject to mandatory clinical data submission: 63 product 
items listed in Annex 12; 
• For medical devices that have built-in software and/or consist of stand-alone 
software, clarifies and streamlines the scope of performance data required for review and approval; 
• Extends the scope of attached documents for technical document review on sterility 
test data of sterile medical devices(recognizes internationally harmonized sterility assurance data); 
• Enlarges the scope of Class I Second-hand Medical Devices which are exempt from 
labelling a test certificate; 
• Clarifies test items and submission data in technical documents for review and 
approval; 
• Streamlines and improves the method of writing STED: Summary Technical 
Documentation (deletes redundant items, enables applicants to submit items considering the original nature of products)  
• Revises the requirements of clinical perfor mance data of in-vitro diagnostics (IVDs). G/TBT/N/KOR/559 
 
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  7. Objective and rationale, including the nature of urgent problems where applicable: 
Promote the health and safety of the public; Build more efficient and systematic review & 
approval process for medical devices  
8. Relevant documents:  MFDS Notification No. 2015-39 (2 February 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 
https://members. wto.org/crnattachments/2 015/TBT/KOR/15_0791_00_x.pdf