マル貯申請

English translation: Market authorization holder application

GLOSSARY ENTRY (DERIVED FROM QUESTION BELOW)
Japanese term or phrase:マル貯申請
English translation:Market authorization holder application
Entered by: V N Ganesh

03:30 Feb 2, 2010
Japanese to English translations [PRO]
Medical - Medical: Instruments
Japanese term or phrase: マル貯申請
「マル貯申請は、五発医療機器申請区分に該当する」

宜しくお願いします
seika
United States
Local time: 17:27
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 -
Selected response from:

V N Ganesh
Local time: 02:57
Grading comment
4 KudoZ points were awarded for this answer



Summary of answers provided
4Application for approval of change in storage method / product life
ProTranslator
2Market authorization holder application
V N Ganesh
Summary of reference entries provided
FYR
cinefil

  

Answers


2 hrs   confidence: Answerer confidence 2/5Answerer confidence 2/5
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 -

V N Ganesh
Local time: 02:57
Specializes in field
Native speaker of: English
PRO pts in category: 16
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1 day 1 hr   confidence: Answerer confidence 4/5Answerer confidence 4/5
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。

ProTranslator
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Reference comments


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...

cinefil
Japan
Works in field
Native speaker of: Native in JapaneseJapanese
PRO pts in category: 29
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