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COMMERCE BUSINESS DAILY ISSUE OF FEBRUARY 7,1997 PSA#1778REPUBLIC OF KOREA: ESTABLISHMENT OF A MINISTERIAL REGULATION ON
PREPARATION OF THE STANDARD AND TESTING METHODS FOR MEDICAL DEVICES The
following notification is being circulated in accordance with Article
10.6. G/TBT/Notif.97.13. 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.
Agency or authority designated to handle comments regarding the
notification can be indicated if different from above. 3. Notified
under Article 2.9.2. 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: Establishment of a
Ministerial Regulation on Preparation of the Standard and Testing
Methods for Medical Devices. 6. Description of content: To establish
the detailed guideline for preparation of the standard and testing
methods for medical devices. 7. Objective and rationale: To clarify the
procedures for preparation of the standard and testing methods. 8.
Relevant documents: Government Official Gazette Number 13500 dated 31
December 1996. 9. Proposed date of adoption: To be determined; Proposed
date of entry into force: To be determined. 10. Final date for
comments: 28 February 1997. 11. Texts available from: National enquiry
point or address and telefax number of other body: Medical Device
Management Division, Ministry of Health and Welfare, 1 Choongang-dong,
Kwachon, Kyunggi-do, 427-760 Republic of Korea, Tel: (82-2) 503-7554,
FAX: (82-2) 504-1396. (0036) Loren Data Corp. http://www.ld.com (SYN# 0598 19970207\FO-0004)
FO - Foreign Government Standards Index Page
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