Apr 27, 2020 19:30
4 yrs ago
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English term

Non-Filing Justification

English to Russian Law/Patents Computers: Software Regulatory Assessment
Контекста нет. Просто расшифровка аббревиатуры в нормативном документе "Regulatory Assessment".

Proposed translations

16 hrs
Selected

согласование без подачи документации

Т.е., если компания укажет причины, по которым она не может подать требуемую документацию, ее заявка может быть рассмотрена и согласована без подачи всей документации
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4 KudoZ points awarded for this answer. Comment: "Благодарю"

Reference comments

18 mins
Reference:

non-filling justification

The non-filing justification is a set of documentation that would confirm that the manufacturer has considered all of the various possible reasons why a new 510(k) submission is not required, and it has determined—after good process—that this truly is the case.
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