医療機器製造販売承認事項記載整備届書

English translation: The application form for approval and verification of medical device manufacturing and sales

13:39 Oct 11, 2012
Japanese to English translations [PRO]
Medical - Medical: Instruments
Japanese term or phrase: 医療機器製造販売承認事項記載整備届書
In the sentence:
医療機器製造販売承認事項記載整備届書」において製造業者及び製造場所が複数あるように表示されている件

Thank you so much
Lara Silbert
Australia
Local time: 18:22
English translation:The application form for approval and verification of medical device manufacturing and sales
Explanation:
医療機器 medical device/equipment
製造 manufacturing
販売 sales
承認事項 approved matter/agenda/detail
記載 description
整備 maintenance
届書 application (form) /report

Taking a look at the expression "記載整備届," it could be a form to describe something revised/corrected/updated from the original application form for medical device registration.
Selected response from:

Akiteru Sasayama
Japan
Local time: 19:22
Grading comment
4 KudoZ points were awarded for this answer



Summary of answers provided
3 +1Notification of description adjustment in medical device marketing approval
Steven Smith
3Pleaes see the explanation
etsukol
1The application form for approval and verification of medical device manufacturing and sales
Akiteru Sasayama
Summary of reference entries provided
FYI
cinefil

  

Answers


7 hrs   confidence: Answerer confidence 1/5Answerer confidence 1/5
The application form for approval and verification of medical device manufacturing and sales


Explanation:
医療機器 medical device/equipment
製造 manufacturing
販売 sales
承認事項 approved matter/agenda/detail
記載 description
整備 maintenance
届書 application (form) /report

Taking a look at the expression "記載整備届," it could be a form to describe something revised/corrected/updated from the original application form for medical device registration.


    Reference: http://www.pmda.go.jp/operations/shonin/info/download/syonin...
Akiteru Sasayama
Japan
Local time: 19:22
Native speaker of: Japanese
PRO pts in category: 4
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9 hrs   confidence: Answerer confidence 3/5Answerer confidence 3/5 peer agreement (net): +1
Notification of description adjustment in medical device marketing approval


Explanation:
These strings can be awkward! I can't find any official translation for the whole thing.

Marketing is sufficient for 製造販売. Device manufacturers receive marketing approval
http://www.j-mdc.com/product.html
http://www.pmda.go.jp/english/service/faq.html

承認事項 is often translated just as 'approval', as 'matters' is somewhat redundant. E.g 承認事項一部変更承認 = partial change approval application.
www.pmda.go.jp/english/service/pdf/guideline_application-2....

Description adjustment is a good solution for 項記載整 and one that I normally use.

http://www.proz.com/kudoz/japanese_to_english/medical:_instr...



Steven Smith
United Kingdom
Local time: 10:22
Specializes in field
Native speaker of: Native in EnglishEnglish
PRO pts in category: 8

Peer comments on this answer (and responses from the answerer)
agree  Yuko Fujita
4 days
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1 day 13 hrs   confidence: Answerer confidence 3/5Answerer confidence 3/5
Pleaes see the explanation


Explanation:
If you just translate it literally, it would be something like,
Matter that seems to indicate several manufacturers and manufacturing sites on "Medical device manufacturing sales approval item entry service (maintenance) report (notification)".
Maybe you can beautify it??

etsukol
United States
Local time: 03:22
Native speaker of: Japanese
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Reference comments


12 hrs
Reference: FYI

Reference information:
http://www.pmda.go.jp/english/service/pdf/guideline_applicat...

金芳堂から出ている「医薬品開発部員のための 和英/英和・翻訳辞典」 内田たけみ著 (¥4,700)では次のようになっていました。
記載整備 : modification to the descriptions/wording
http://189info.blog86.fc2.com/blog-entry-1461.html

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