Japanese term
Australia
Experienced, reliable JAEN translator
Native in: English
Works in: Japanese to English, English
医療機器製造販売承認事項記載整備届書
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
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
Japan
Native in: Japanese (Variants: Standard-Japan, Kansai)
Works in: English to Japanese, Japanese to English
The application form for approval and verification of medical device manufacturing and sales
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.
United Kingdom
Notification of description adjustment in medical device marketing approval
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...
Pleaes see the explanation
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??
Reference comments
FYI
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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