G/TBT/N/KOR/453  
 
30 October 2013  
(13-5987)  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 of 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, Cheongwon-gun, 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 [   ], 2.10.1 [   ], 5.6.2 [X], 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:  
The Enforcement Rule of the Medical Devices Act (87 pages, available in Korean)     
6. Description of content:   
- Adjustment of the scope of a fiduciary: to  delete qualification requirements to be a 
fiduciary for entire manufacturing process and imposing the responsibility of oversight and supervision upon the consignor, not the fiduciary; 
- Strengthening license requirements of medical device manufacturing /importing: 
to submit its GMP certificate to quality control inspectors for application of an item approval. If not valid, reapply to GMP certificate with supplementary document; 
- Introducing a mandatory clinical data submission: to provide a legal basis for a 
clinical data submission in order to designate medical devices which are required clinical data submission for its technical documents review; 
- Consolidating IVD management system into a single official channel: In Vitro 
Devices as a drug which have been under the Pharmaceutical Act will be regulated 
as a medical device Under the Medical Devices Act; 
- Annulling business license submission when a holder wishes to modify its original 
contents: to moderate regulation in terms of modification requirements on a 
business licence.  G/TBT/N/KOR/453 
 
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  7. Objective and rationale, including the nature of urgent problems where 
applicable:   
- It aims to raise reliability of medical devices by verifying GMP certificate, and by 
amending approval and review processeswith regard to clinical data submission; 
- It aims to facilitate a process for modification of an original business licence by 
reducing supporting documents; 
- It aims to improve the current regulations through abolishing qualification 
requirements for a fiduciary. 
8. Relevant documents:   MFDS NOTIFICATION No. 2013-192   
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/2013/tbt/KOR/13_4314_00_x.pdf