REPUBLIC OF KOREA: ESTABLISHMENT OF A MINISTERIAL REGULATION ON THE ISSUANCE PROCEDURE FOR THE MANUFACTURERS' LICENCE AND PERMISSION PROCEDURE FOR MANUFACTURE AND IMPORTATION OF MEDICAL DEVICES The following notification is being circulated in accordance with Article 10.6. G/TBT/Notif.97.14. 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 the Issuance Procedure for the Manufacturers' Licence and Permission Procedure for Manufacture and Importation of Medical Devices. 6. Description of content: To regulate the conditions and procedures for issuing manufacturers' licence and for giving permission to manufacture and import medical devices. 7. Objective and rationale: To ensure the safety and effectiveness 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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