Катрен Стиль
Изменились правила ведения государственного реестра медицинских изделий
Со следующего года в государственном реестре медицинских изделий Росздравнадзора нужно будет указывать больше сведений для каждой позиции. Соответствующее Постановление Правительства РФ от 30 сентября 2021 года № 1650 опубликовано 1 октября.
В частности, теперь в реестре, помимо прежней информации (наименование владельца регистрационного удостоверения, код ОКВЭД, информация о назначении), появятся фотографии каждого медицинского изделия, а также оцифрованная версия инструкции по применению.
Для медицинских изделий, представляющих из себя программное обеспечение для диагностики или другой помощи медицинским работникам, в реестре обязательно будут присутствовать скриншоты интерфейса, а также фотографии электронного носителя, на котором поставляется это ПО.
Ранее Министерство здравоохранения утвердило новый протокол изъятия медицинских изделий для проведения испытаний. Такой документ проверяющие будут заполнять, если при проведении проверки они забирают какие‑то изделия для изучения их на предмет соответствия всем законным требованиям.
4 октября 2021
Фото: depositphotos.com
Выпуск: №214, октябрь 20211626 просмотров
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1626 просмотров
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