. /.  WORLD TRADE  
ORGANIZATION  G/TBT/N/KOR/65 
16 December 2003 
 (03-6618) 
Committee on Technical Barriers to Trade Original:  English 
   
NOTIFICATION 
 
The following notification is being circ ulated in accordance with Article 10.6. 
 
1. Member to Agreement notifying:   :  REPUBLIC OF KOREA
 
If applicable, name of local government involved (Articles 3.2 and 7.2):         
2. Agency responsible:   Ministry of Health and Welfare 
Name and address (including telephone and fax numbers, e-mail and web-site 
addresses, if available) of  agency or authority designated to handle comments 
regarding the notification shall be  indicated if different from above:         
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 applicable, otherwise national tariff heading. 
ICS numbers may be provided in  addition, where applicable):   Medical Device 
5. Title, number of pages and language(s) of the notified document:   Proposed 
Enforcement Regulation of the Medical Device Act (147 pages, in Korean) 
6. Description of content:    
- Procedure and method for classification and designation of medical devices 
- Details on document submissions and other requirements regarding application for 
manufacture or import licenses, product approval and/or reporting to the 
government (including reporting of change) 
- Details of document submissions requi rements and guidelines for approval of 
applications for post-market surveillance a nd re-evaluation, and clinical trial plans 
- Details on manufacturer/importer’s reporting to the government of discontinuation 
of businesses, production reports, and other matters to be observed 
- Reporting of start-ups in rental, distri bution or repair businesses; procedures and 
methods for change in notification; ma tters to be observed by the businesses 
- Matters to be observed by each business party with regard to establishing and 
maintaining fair marketing practices 
- Details on requirements regardi ng labelling and advertisement 
- Range of devices subject to tracking and monitoring; details on record-keeping and 
retention of records G/TBT/N/KOR/65 
Page 2  
 
- Details on reporting of seriously harmful si de-effects and keeping of related records 
- Criteria for administrative penalties, incl uding suspension of business for serious 
violations; details on procedures and met hods for administrative fine collection 
- Qualifications and range of responsibiliti es of medical device surveillance officers 
in relation to post-market surveillance of devices 
- Renewal, re-issuance and confirmation of license and/or certificate of approval, and 
related fee payment procedures, etc. 
7. Objective and rationale, including the na ture of urgent problems where applicable:  
To stipulate detailed provisions in the Enforc ement Regulation, as delegated by the Medical 
Device Act promulgated on 29 May 2003 
8. Relevant documents:   Medical Device Act(Act No. 6909) (Available in Korean only) 
9. Proposed date of adoption:  undetermined  
Proposed date of entry into force:  May 2004 
10. Final date for comments:   31 January 2004 
11. Texts available from:  National enquiry point [    ] or address, telephone and fax 
numbers, e-mail and web-site addresses, if available of the other body:   
Documents are available from the Ministry of Health and Welfare website 
(www.mohw.go.kr ).  Also available from :  
 International Cooperation Division 
 Ministry of Health and Welfare 
 1, Joongang-dong Kwancheon, Kyunggi  27-721, Republic of Korea    Tel: +82 2 503 7524 
 Fax: +82 2 504 6418 
 E-mail: iicd@mohw.go.kr