DOI QR Code
(식품의약품안전평가원 의료제품연구부)
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(식품의약품안전평가원 의료제품연구부)
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(식품의약품안전청 의료기기안전국)
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(식품의약품안전청 의료기기안전국)
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(Phamaceuticals & Medical Device Research Department, National Institute of Food and Drug Safety Evaluation)
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(Phamaceuticals & Medical Device Research Department, National Institute of Food and Drug Safety Evaluation)
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(Medical Device Safety Bureau, Korea Food and Drug Administration)
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(Medical Device Safety Bureau, Korea Food and Drug Administration)
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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.