치과재료 품목의 국제조화를 위한 각국 분류체계의 비교연구

Abstract

The import and export of newly developed dental materials sometimes face difficulties due to the discrepancy in dental materials' classification system between Korea and other countries. Hence, to resolve this problem and to internationalize industrial development, improvement of the classification system that harmonized with international standards would be required. The aim of this study was to prepare a scheme for the global harmonization of the classification system for dental materials which may contribute toward the internationalization of a management system. The study was carried out by first reviewing and analyzing the currently available regulation for the dental materials' classification system. Then, the subdivisions of classification system for dental materials in Korea were compared with the equivalent systems of U.S., Europe, Japan and China. Finally, proposal for modifications of subdivisions in the dental materials classification was made, where dental devices that were previously approved but not yet been assigned to subdivisions of classifications (those assigned to broad category) were reviewed. The results of this study would provide valuable information to Ministry of Food and Drug Safety in Korea in terms of establishing a new globally harmonized classification system. In addition, contents and changes from this study would be helpful to the developer, importer or exporter of dental devices.