Oct 11, 2012 13:39
11 yrs ago
7 viewers *
Japanese term

医療機器製造販売承認事項記載整備届書

Japanese to English Medical Medical: Instruments
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
References
FYI
Change log

Oct 14, 2012 20:21: Steven Smith changed "Field" from "Other" to "Medical" , "Field (specific)" from "General / Conversation / Greetings / Letters" to "Medical: Instruments"

Proposed translations

7 hrs
Selected

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

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.
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4 KudoZ points awarded for this answer.
+1
9 hrs

Notification of description adjustment in medical device marketing approval

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...

Peer comment(s):

agree Yuko Fujita
4 days
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1 day 13 hrs

Pleaes see the 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??
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Reference comments

12 hrs
Reference:

FYI

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
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