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KMID : 1142220160110010043
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Regulatory Research on Food, Drug & Cosmetic
2016 Volume.11 No. 1 p.43 ~ p.53
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A Study on Development of Guideline on Writing Technical Documents for Electrical Medical Devices : SPECT·SPECT-CT·Gamma Camera
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Lee Seung-Youl
Kim Jae-Ryang
Kim Eun-Rim
Lee Jun-Ho
Lee Chang-Hyung
Park Chang-Won
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Abstract
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The market size of SPECT·SPECT-CT·Gamma camera and the number of their approval by Ministry of Food and Drug Safety (MFDS) has increased, with a trend of increasing aging population. For approval of manufactured or imported medical devices in Republic of Korea, it is required to submit its technical document. Therefore, it is need to develop the technical document guideline for SPECT (Single Photon Emission Computed Tomography) ·SPECT-CT·Gamma camera. First of all, the technical documents which were already approved were examined and analyzed through MFDS approval administration system. Second, safety and performance test standards and methods that match the international standards were drawn after conducting survey of the market status and the technology development trend for it, with examination/analysis of applicable domestic and overseas standards. Third, by operating industry-research-government cooperation, the guideline draft on writing technical document for SPECT·SPECT-CT·Gamma camera was discussed with collecting opinion. As a result, it is suitable to international and domestic condition, includes test evaluation methods and offer various information with appropriate examples. Furthermore, it could help them get approval of medical devices and advance into medical devise markets.
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KEYWORD
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SPECT, SPECT-CT, Gamma camera, Technical documents for electrical medical devices, Medical device regulation
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FullTexts / Linksout information
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Listed journal information
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