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의료기기 허가.기술문서 원자재 작성 가이드라인 개발
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  • 의료기기 허가.기술문서 원자재 작성 가이드라인 개발
저자명
박기정,유규하,이성희,이창형,정진백,이재근,허찬회,김형범,최민용,김용우,황상연,정재훈,구자중,홍혜경,임경택,강세구,곽지영,Park. Ki-Jung,Ryu. Gyu-Ha,Lee. Sung-Hee,Lee. Chang-Hyung,Jun
간행물명
Journal of biomedical engineering research : the official journal of the Korean Society of Medical & Biological Engineering
권/호정보
2010년|31권 6호|pp.434-437 (4 pages)
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이 논문은 한국과학기술정보연구원과 논문 연계를 통해 무료로 제공되는 원문입니다.
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기타언어초록

For approval of medical devices manufactured or imported, submission of technical documents as well as the application form is required. The manufacturer (or importer) should properly identify the raw materials the applied product is made of and the manufacturing processes the product undergoes before it is shipped in the application form. In the technical documents, scientific data to evaluate the efficacy, safety, and quality of the applied product that has been described in the application form should be provided. Therefore, identifying the raw materials that were used for the parts of the applied product and describing the physical and chemical characteristics of the raw materials are quite important and essential in ensuring the efficacy, safety, and quality of the applied product. To describe the physical and chemical characteristics of the raw materials correctively, the applicant is required to have broad knowledge in the scientific fields such as chemical, polymer, metal, and ceramic science and engineering. But most of the applicant are not experts in these fields, so that the description in the application form often includes wrong and improper descriptions. Thus, we developed a guideline which explains the raw materials for medical devices, show the their examples. The purpose of this description guideline is to help the applicant properly completing the "Raw materials or constituents and their volumes" part in the application form.