REPUBLIC OF KOREA: DRAFT REVISION OF THE MINISTERIAL REGULATION ON THE MANAGEMENT OF IMPORTED MEDICAL DEVICES The following notification is being circulated in accordance with Article 10.6. G/TBT/Notif.97.17. 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: Draft Revision of the Ministerial Regulation on the Management of Imported Medical Devices. 6. Description of content: To specify the conditions and procedures for imported medical device on customs clearance, quality control, distribution, etc. 7. Objective and rationale: To ensure the quality of medical devices and rationalize the management system. 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: 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)

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