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Производителям медизделий не придётся менять регистрационные удостоверения из‑за правил ЕЭАС
Производителям медизделий не придётся менять регистрационные удостоверения из‑за правил ЕЭАС
Совет Евразийской экономической комиссии 5 апреля одобрил изменения в правила обращения медицинских изделий (МИ), которые разрешают оборот МИ, зарегистрированных по национальным правилам, до конца срока действия регистрационного удостоверения.
Напомним, что с 1 января 2022 года регистрация медицинских изделий в странах ЕАЭС будет проходить по единым правилам, утверждённым решением Совета Евразийской экономической комиссии от 12 февраля 2016 г. № 46. При этом до 31 декабря 2021 года производители имеют право пройти регистрацию в соответствии с порядком, действующим в своей стране.
Принятые комиссией изменения разрешают оборот медицинских изделий, получивших свою регистрацию по национальным правилам, до конца срока действия выданного удостоверения. Таким образом, производителям в 2022 году не придётся проходить повторную процедуру регистрации МИ по правилам ЕАЭС.
Напомним, что ранее Министерство здравоохранения подготовило проект нового порядка государственной регистрации медицинских изделий. Он будет действовать до конца года, пока его не сменит порядок, утверждённый комиссией ЕАЭС.
7 апреля 2021
Фото: depositphotos.com
Выпуск: №207, апрель 20211219 просмотров
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