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薬生機審発0517第1号 平成29年5月17日 各都道府県衛生主管部（局）長 殿 厚生労働省医薬・生活衛生局医療機器審査管理課長 （公 印 省 略） 医療機器の基本要件基準第12条第2項の適用につ …
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クラ アプ認証基準の概要 ... - std.pmda.go.jp
www.std.pmda.go.jp3 5 2. 今回の認証基準作成の考え方 基本的な方法 iso/iec 認証基準 品目固有の公的規格や国際規格を元に技術基準を作成 既存jisを利用して技術基準を作成
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