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COMMERCE BUSINESS DAILY ISSUE OF FEBRUARY 7,1997 PSA#1778REPUBLIC OF KOREA: ESTABLISHMENT OF A MINISTERIAL REGULATION ON THE GMP
(GOOD MANUFACTURING PRACTICES) FOR MEDICAL DEVICES The following
notification is being circulated in accordance with Article 10.6.
G/TBT/Notif.97.16. 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 and number of pages of the
notified document: Establishment of a Ministerial Regulation on the GMP
(Good Manufacturing Practices) for Medical Devices. 6. Description of
content: To regulate the GMP conditions and standards which medical
device manufacturers are encouraged to observe. 7. Objective and
rationale: To guarantee the production and distribution of safe and
high-quality medical devices. 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. Text
available from: 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# 0609 19970207\FO-0015)
FO - Foreign Government Standards Index Page
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