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03:30 Feb 2, 2010 |
Japanese to English translations [PRO] Medical - Medical: Instruments | |||||||
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| Selected response from: V N Ganesh Local time: 02:57 | ||||||
Grading comment
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Summary of answers provided | ||||
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4 | Application for approval of change in storage method / product life |
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2 | Market authorization holder application |
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Summary of reference entries provided | |||
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FYR |
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Market authorization holder application Explanation: Japanese regulation requires a Market Authorization Holder (MAH) located in Japan for your products. The MAH license has 3 levels which defines what classes of medical device can be handled by the MAH: Type 1 license: “Specially Controlled Medical Devices” and other low risk devices (All classes of Ⅰ, Ⅱ, Ⅲ and Ⅳ) Type 2 license : “Controlled Medical Devices” and lower risk devices (Class Ⅰ and Ⅱ) Type 3 license : “General Medical Devices”(ClassⅠdevices only) The MAH is legally responsible for the device and adverse event reporting..... 株式会社医療機器法規制QMS研究所」”:“MiRQ" "Medical Devices Institute of RA & QMS Co., Ltd." .... Documentation translation into Japanese. ... meddevmirq.com/EnglishHomePage20090717.aspx - |
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Application for approval of change in storage method / product life Explanation: 体外診断薬の貯蔵方法及び有効期間の変更申請です。 |
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34 mins |
Reference: FYR Reference information: (3)申請品目が既承認医療機器と同一のもの(昭和62年9月21日付け薬発第821号厚 生省薬務局長通知「医薬品等の製造承認、輸入承認及び外国製造承認の取扱いにつ いて」による申請(いわゆるマルT申請)、承認申請留意事項通知の第4.3の(3) に規定する=部変更申請(いわゆるマル貯申請)等)又は原料供給元の事情による 同等の原材料の変更など、申請品目が既承認医療機器に対して特段の差別化を意図 するものでない場合には、その旨を記載すること。 http://www.pmda.go.jp/operations/shonin/info/iryokiki/file/i... |
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