REPUBLIC OF KOREA: ESTABLISHMENT OF A MINISTERIAL REGULATION ON MEDICAL DEVICE DESIGNATION, ETC. The following notification is being circulated in accordance with Article 10.6. G/TBT/Notif.97.12. 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 Medical Device Designation, etc. 6. Description of content: To designate and classify medical devices according to their risks to human health; to specify the procedure for designating new medical devices and re-classifying existing medical devices according to their risks to human health. 7. Objective and rationale: To ensure the effective management of 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. 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)

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