WORLD TRADE
ORGANIZATIONG/TBT/Notif.00/275
23 June 2000
(00-2552)
Committee on Technical Barriers to Trade
NOTIFICATION
The following notification is being circulated 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:   Korea Food and Drug Administration
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 Devices
5. Title, number of pages and language(s) of the notified document:   Public Notification of
Draft Enactment of Particular Requirement for Safety of Medical Devices (306 pages)
6. Description of content:   Additionally establishes the particular requirement for safety of
29 dental materials and of 13 medical devices including electrocardiograph, and matches theparticular requirement with the international standards such as IEC or ISO.
7. Objective and rationale, including the na ture of urgent problems where applicable:
This amendment is to provide applicants for approval with clear standards, increase
transparency and promptness of approval process, and achieve proper quality control.
8. Relevant documents:   Particular requirement of IEC 601 and particular requirement of ISO
for dental materials.
9. Proposed date of adoption:
Proposed date of entry into force: }August 2000
10. Final date for comments:   25 July 2000
11. Texts available from:  National enquiry point [     ] or address, e-mail and telefax
number of the other body:
Medical Device Division
Korea Food and Drug Administration
#5 Nokbun-dong,
Eunpyung-ku, SeoulRepublic of Korea, 122-020
Tel: +82.2 380 16.69
Fax: +82.2 388 63.94