G/TBT/N/KOR/489  
 
7 May 2014  
(14-2823)  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 [ 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:  Proposed 
Amendment of "Regulations on Approval, Notification and Review of Medical Devices" 
(17 pages, available in Korean)     
6. Description of content:   
- Establish the definition for "Implantable medical device", and require their 
 application forms to declare that it is an "implantable medical device". 
- Prohibit the approval and notification of products containing hazardous raw 
materials to human beings such as mercury, asbestos, and phthalate (for phthalate, only relevant to intravascular administration sets). 
-
 Reform approval procedures so that when the "intended use" of a medical device 
is modified, it is managed as an "Approval for modification" instead of a "New Approval". 
-
 Reform submission criteria of clinical data to require the submission of methods, 
results of clinical trials, and other relevant data for evaluation.  
- Enlarge the scope of exemption in sale business notifications to include 
distributors of mobile medical applications intended for self-diagnosis/monitoring 
or health care products with medical mobile application running on mobile 
platforms. G/TBT/N/KOR/489 
 
- 2 - 
 
  7. Objective and rationale, including the nature of urgent problems where 
applicable:   
- Aiming to manage the status of approval of implantable medical devices, in order 
to enable swift responses (e.g. recalls)to adverse events of implanted medical 
devices with comparatively higher levels of risk. 
- Seeking to prohibit the approval of medical devices containing hazardous raw 
materials that are problematic in their safety effectiveness. It is expected to 
prevent public health risks. 
- Aiming to increase administrative efficiency by reforming regulations on medical 
devices with modified intended use. Such cases will be managed as an approval 
for modification instead of a new approval.  
- Seeking to address issues of in equity an d inconsistency related to the acceptance 
of clinical data of the current system. Those who have submitted clinical data to 
an OECD member country or SCI journals will need to submit additional clinical 
data such as methods, results and evaluation data. Under the current regulation, clinical data submitted to an OECD Member country for approval application of a 
medical device, as well as SCI journals are recognised as appropriate for 
submission even though in some cases, the supporting evidence is insufficient 
and/or clinical cases need to be evaluated. 
- Aiming to increase customer accessibility and promote the medical device industry 
by exempting distributors of mobile medical applications intended for self-diagnosis/monitoring or health care products with medical mobile applications running on mobile platforms from having to notify sale business. This is expected 
to diminish some complications that distributors may face by exempting them 
from having to acquire a license for sales/distribution. 
8. Relevant documents:   MFDS NOTIFICATION No. 2014- 87(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_2244_00_x.pdf