G/TBT/N/KOR/506  
 
8 July 2014  
(14-3889)  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 Osongsaengmyeong-ro 
Osong-eup Cheongwon-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 [   ], 2.10.1 [   ], 5.6.2 [ X ], 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 
Amendments to the Standards for Manufacture and Quality Management of Medical Device 
(125 pages, available in Korean) 
6. Description of content: The proposed amendment aims the following:  
- Reclassify GMP inspections into 'conformity inspections' and 'regular inspections', and 
clarify terminologies related to GMP inspection. 
- Have Quality Management Inspection Institutions conduct independent GMP inspections 
on Class II medical devices. However, for manufacturers with history of non-conformity 
with GMPs or high possibility of not conformi ng with GMPs, the MFDS will also co-inspect. 
- For GMP certificates subject to 'regular inspections' before they reach their expiration 
dates, the reference date for the renewed term of validity will be changed from the issuing 
date to the date following its expiration date. 
- Specify criteria for the issuing of GMP certificate, its management, entry items. - Have manufacturers voluntarily manage GMP certificates regarding trivialchanges, such 
as the name of manufacturing company and company representative. Manufacturers may 
correct such changes without having to apply for a new GMP certificate. G/TBT/N/KOR/506 
 
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  - Establish regulations and criteria regarding the designation of institutions responsible for 
training Quality Management Inspectors, their evaluation methods, training content, requirements, etc. 
- When applying for onsite GMP inspections, manufacturers must apply 20 days prior to 
the requested date of inspection. In the case of regular GMP inspections, manufacturers must apply 20 days prior to the expiration date on their existing GMP certificates. 
For first inspections and inspection for additions or changes, manufacturers may submit 
only the Device Master Record of the representative device from the device category. 
7. Objective and rationale, including the nature of urgent problems where applicable: 
Protection of human health or safety  
8. Relevant documents:  MFDS Notification No. 2014-155 (11 June 2014) 
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 date of 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) 
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