REPUBLIC 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)

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