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KMID : 1137820100310060434
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의공학회지
2010 Volume.31 No. 6 p.434 ~ p.437
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The Development for guideline of raw matrials on technical document of Medical Device
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Park Ki-Jung
Rye Gyu-Ha
Lee Sung-Hee
Lee Chang-Hyung
Jeong Jin-Baek
Lee Jae-Keun
Hur Chan-Hoi
Kim Hyung-Bum
Choi Min-Yong
Kim Yong-Woo
Hwang Sang-Yeon
Jung Jae-Hoon
Koo Ja-Jung
Hong Hye-Kyung
Lim Kyoung-Taek
Kang Se-Gu
Kwak Ji-Young
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Abstract
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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.
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KEYWORD
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raw materials, technical documents, guideline
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FullTexts / Linksout information
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Listed journal information
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