WORLD TRADE
ORGANIZATIONG/TBT/Notif.00/98
24 February 2000
(00-0700)
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:   National Enquiry Point
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 General Requirement for Biological Safety of Medical Devices
(54 pages;  Korean)
6. Description of content:   Harmonization of General Requirement for Biological Safety of
Medical Devices in Korea with ISO 10993
7. Objective and rationale, including the na ture of urgent problems where applicable:
Specification of general requirement for biological safety of medical devices
8. Relevant documents:   ISO 10993
9. Proposed date of adoption:
Proposed date of entry into force: }Not stated
10. Final date for comments:   31 March 2000
11. Texts available from:  National enquiry point [ X] or address, e-mail and telefax
number of the other body:
Medical Device Division
Korea Food and Drug Administration
#5, Nokbun-dong, Eunpyung-ku
Seoul, 122-704, Korea
Tel: +822-380.16.19
Fax: +822-388.63.94