Oct 25, 2017 16:55
6 yrs ago
3 viewers *
English term
(device) listing information
English to Russian
Medical
Medical: Health Care
MDSAP (Программа единого аудита изготовителей медицинских изделий)
During audit of the Management process, ascertain the responsibilities and authorities of employees responsible for ensuring proper registration, licensing, notification and **listing information** is accurately submitted to regulatory authorities or authorized representatives (e.g. Australian Sponsor) participating in the MDSAP.
Submitted **device listing information** to regulatory authorities when applicable
Submitted **device listing information** to regulatory authorities when applicable
Proposed translations
(Russian)
| 4 | * |
hawkwind
|
| 4 | [внесение в] перечень выпускаемых изделий |
Katerina O.
|
Proposed translations
9 hrs
Selected
*
информация (для) перечня медицинских изделий для регулирующего органа
http://www.gaccmidwest.org/fileadmin/ahk_chicago/White_Paper...
Establishment Registration and Device Listing - 21 CFR Part 807
Owners or operators of places of business (also called establishments or facilities) that
are involved in the production and distribution (including importers) of medical devices
intended for use in the United States (U.S.) are required to register annually with the FDA.
Most establishments that are required to register with the FDA are also required to list the devices that are made there
and the activities that are performed on those devices
Внесение в список медицинских изделий (Medical Device Listing, по Форме FDA 2892), продаваемых на рынке.
http://www.nancystark.com/FDA_Form_2892_Listing.pdf
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Note added at 9 hrs (2017-10-26 02:47:54 GMT)
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https://www.google.ru/url?sa=t&rct=j&q=&esrc=s&source=web&cd...
http://www.gaccmidwest.org/fileadmin/ahk_chicago/White_Paper...
Establishment Registration and Device Listing - 21 CFR Part 807
Owners or operators of places of business (also called establishments or facilities) that
are involved in the production and distribution (including importers) of medical devices
intended for use in the United States (U.S.) are required to register annually with the FDA.
Most establishments that are required to register with the FDA are also required to list the devices that are made there
and the activities that are performed on those devices
Внесение в список медицинских изделий (Medical Device Listing, по Форме FDA 2892), продаваемых на рынке.
http://www.nancystark.com/FDA_Form_2892_Listing.pdf
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Note added at 9 hrs (2017-10-26 02:47:54 GMT)
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https://www.google.ru/url?sa=t&rct=j&q=&esrc=s&source=web&cd...
4 KudoZ points awarded for this answer.
Comment: "Спасибо"
9 hrs
Katerina O.
Russian Federation
Russian Federation
Native in Russian
Russian Federation
Grasp the subject, the words will follow
Native in: Russian
Works in: English to Russian, Russian to English
Related KudoZ points
:
20
[внесение в] перечень выпускаемых изделий
например:
ответственные за предоставление в... сведений для регистрации, лицензирования, notification и внесения в перечень выпускаемых изделий
...
Most establishments that are required to register with the FDA are also required to list the devices that are made there and the activities that are performed on those devices. https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidan...
ответственные за предоставление в... сведений для регистрации, лицензирования, notification и внесения в перечень выпускаемых изделий
...
Most establishments that are required to register with the FDA are also required to list the devices that are made there and the activities that are performed on those devices. https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidan...
Note from asker:
| Спасибо |
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