Can you please check a short extract. Thank you
Notification procedure is described in detail in the Russian Medical Device Registration Rules. In case of changes, the registration certificate remains the same, but changes notification letter must be submitted. Changes are approved as soon as they are confirmed by special letter of the Ministry of Health. Official procedure timelines for Russia are 30 days, which could be prolonged by 20 business days period for expertize.
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Can you please check a short extract? Thank you.
The notification procedure is described in detail in the Russian Medical Device Registration Rules. In the event of a change, the registration certificate will remain the same, but a change notification letter must be submitted. Changes are approved as soon as they are confirmed by special letter from the Ministry of Health. Official procedure timelines for Russia are 30 days, which may be extended for an additional 20 business days period for expertise. ??
Sorry, I can't quite understand the last phrase, "for expertise". If you paraphrase in English or write the sentence in Russian, I will try again to help. However, if you mean that there may be an extention of 20 business days so that the Ministry can evaluate the change notification letter, you could say, "... which may be extended for an additional 20 business days if required for evaluation of the change notification letter."
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