Минздрав планирует ужесточить контроль в сфере оборота медицинских изделий
12 мая 2020
Фото: depositphotos.com
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№196, май 2020
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Минздрав планирует ужесточить контроль в сфере оборота медицинских изделий
Ведомство подготовило поправки в Положение о государственном контроле за обращением медицинских изделий. Они изменят критерии, по которым организации, осуществляющие оборот медизделий, получают категорию риска. Проект изменений опубликован 8 мая на портале нормативных актов.
Напомним, что в отношении проверок, связанных с оборотом медицинских изделий, применяется риск-ориентированный подход. Организации получают баллы в зависимости от выполняемой деятельности, по сумме которых им присваивается определенная категория риска нарушений обязательных требований — от низкого до значительного. Чем ниже присвоенная организации категория, тем реже в отношении нее проводятся плановые проверки.
В пояснительной записке к проекту указано, что с момента утверждения критериев риска в 2017 году значительно выросло количество сообщений о неблагоприятных событиях по всем классам потенциального риска применения медицинских изделий. Таким образом, в Минздраве видят необходимость в пересмотре законодательства.
Поправки ориентированы в первую очередь на усиление контроля за производителями, которые сейчас по большей части попадают в категорию низкого риска, и плановые проверки в их отношении не проводятся. Еще одной целью изменений является ужесточение проверок организаций, проводящих клинические испытания медицинских изделий. Как указано в пояснении, по результатам плановых проверок таких медицинских учреждений в 65 % случаев были выявлены нарушения.
В среднем к каждому критерию присвоения категории риска прибавилось по два балла. Например, количество баллов за реализацию и хранение медицинских изделий увеличилось с 2 до 4, а за количество видов медицинских изделий, зарегистрированных производителем, — с 4 до 6 (менее 10 видов изделий).
Катрен Стиль
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