한국 식품의약품안전청 및 외국의 치과재료 분류체계 조사
The Research of Classification Systems for Dental Materials of Korea Food and Drug Administration and Other Countries
양송이, 김미주, 박은주, 김경남, 김광만,
소속 상세정보
양송이 ( Yang Song-Yi ) - 연세대학교 치과대학 치과생체재료공학교실 및 연구소
김미주 ( Kim Mi-Joo ) - 연세대학교 치과대학 치과생체재료공학교실 및 연구소
박은주 ( Park Eun-Joo ) - 연세대학교 치과대학 치과생체재료공학교실 및 연구소
김경남 ( Kim Kyoung-Nam ) - 연세대학교 치과대학 치과생체재료공학교실 및 연구소
김광만 ( Kim Kwang-Mahn ) - 연세대학교 치과대학 치과생체재료공학교실 및 연구소
KMID : 0362220120390030251
Abstract
The Korea Food and Drug Administration published new ‘medical device classification system’ for more transparent and internationally harmonized classification system as the medical products types are rapidly diversified and increased. The aim of this study was to find the way of improving the efficiency of dental materials classification by comparing classification system of Korea and other countries. For this research, the classification system of Korea, Europe, Japan, USA and China were collected. The collected data were reviewed and the difference between classification systems of Korea and other countries were compared. The subdivision of classification system of dental materials in Korea, USA and Japan are as follows, subsequently; 27 medium classification and 149 subclassification, 5 medium classification and 132 subclassification, and 9 medium classification and 279 subclassification according to usage, ingredients and forms of products. Classification system of dental devices in GMDN(Global Medical Device Nomenclature) is subdivided to 749 subclassification without distinction of dental devices and materials, and in China, it is subdivided to 15 medium classification and 59 subclassification according to usage of products. The development of dental materials and import or
export of them may have difficulty due to the difference in classification system between Korea and systems in each country. In order to overcome this difficulty, the competence of the selection of products that shows significant difference between Korea and other countries should be reassessed. Also like USA or GMDN of Europe, where the classification of medical devices are continuously modified, Korea should actively seek a plan for stable classification systems that can be unified with the other countries. The result of this study may improve the efficiency of dental materials classification by suggesting solution to such problems which occur in distribution or development of dental materials.
키워드
Classification system; Comparison; Dental materials; Korea; Other country
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