May 2, 2003 22:58
22 yrs ago
Japanese term
United States
Expert: high-tech, software, engineering
Native in: Hungarian 
Works in: English to Hungarian, Japanese to English, Hungarian to English, and 3 more.
その概略 (in this particular context)
Japanese to English
Medical
Medical regulations
「申請医療用具と構造・原理は同一で型式、エネルギー出力、適用部位、使用目的等の異なる医療用具を開発している場合には、その概略を付記すること」
上記の文書の場合、「その概略」の「その」が何を示しているのでしょうか？
開発の概略ですか？
それとも
開発している医療用具の概略ですか？
それとも
申請医療用具と開発医療用具の異点の概略ですか？
上記の文書の場合、「その概略」の「その」が何を示しているのでしょうか？
開発の概略ですか？
それとも
開発している医療用具の概略ですか？
それとも
申請医療用具と開発医療用具の異点の概略ですか？
Proposed translations
(English)
Proposed translations
+1
59 mins
Nobuo Kawamura
Japan
Japan
Native in Japanese
Japan
professional translator since 2001
Native in: Japanese
Works in: English to Japanese, Italian to Japanese, Spanish to Japanese, and 3 more.
Related KudoZ points
:
483
Selected
開発している医療器具の概略
Your second alternative is correct.
4 KudoZ points awarded for this answer.
Comment: "This was my first instinct, too, and this seems to be the one most of you agreed with. I agree the original Japanese is ambigous, and it's a shame because it is from official regulatory text, expected to be clear and straightforward. "
6 mins
Yoshiro Shibasaki, PhD
United Kingdom
United Kingdom
Native in Japanese
United Kingdom
PhD in medical science
Native in: Japanese 
Works in: English to Japanese, German to Japanese, Danish to Japanese, and 2 more.
Related KudoZ points
:
108
differences and similarities
They are asking summary of "differences and similarities" in your case instead of repeating already known details.
「その」is referred to the "differences and similarities".
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Note added at 2003-05-03 08:43:42 (GMT)
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If the deveice is made in the same principle and/or structure, and differences are minimum such as the application site and/or purpose, (a detailed description of the device is not required but) summary thereof should be amended.
「その」is referred to the "differences and similarities".
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Note added at 2003-05-03 08:43:42 (GMT)
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If the deveice is made in the same principle and/or structure, and differences are minimum such as the application site and/or purpose, (a detailed description of the device is not required but) summary thereof should be amended.
13 mins
造・原理は同一で型式、エネルギー出力、適用部位、使用目的等の異なる医療用具
If you just look at the sentence, most likely, "its outline" would refer to the outline of the medical equipment whose type, energy output, applicable part, purpose, and so on are different from the equipement whose structure and fundamentals are identical.
However, since the original Japanese sentence is very ambiguous, your other suggestions may be true.
However, since the original Japanese sentence is very ambiguous, your other suggestions may be true.
7 hrs
Hirohisa Oda
Native in Japanese
&
English
Bi-lingual English and Japanese team
Native in: Japanese , English
Works in: Japanese to English
Related KudoZ points
:
176
device being developed based on the same production principle
Attach an abstract for the device, if you are developing a different model, different output energy, using it in different locations, or using it for a different purpose than your original device application.
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Note added at 2003-05-03 06:36:51 (GMT)
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This Japanese is the general writing style used for medical device applications.
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Note added at 2003-05-03 06:36:51 (GMT)
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This Japanese is the general writing style used for medical device applications.
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