ГОСУДАРСТВЕННОЕ РЕГУЛИРОВАНИЕ РОССИЙСКОГО РЫНКА МЕДИЦИНСКИХ ИЗДЕЛИЙ
Аннотация
Предметом исследования выступает государственное регулирование рынка медицинских изделий в Российской Федерации. Сегодня он в высокой степени зависит от импорта и страдает от недостаточной прозрачности процедур сертификации и стандартизации. Проблема заключается в институциональной фрагментации, несогласованности полномочий и устаревших нормативных механизмах. Все это препятствует внедрению инноваций и снижает конкурентоспособность отечественных производителей.
Цель работы – предложить комплекс решений по совершенствованию государственного регулирования рынка медицинских изделий Российской Федерации. Для достижения цели применялись статистико-экономический и балансовый методы, контент-анализ документов на предмет определения возникающих противоречий в НПА и дисфункций регулирующих рынок государственных органов.
Результаты исследования показали, что ключевыми барьерами развития рынка являются избыточные административные процедуры, несовершенство стандартов и доминирование ценового критерия при госзакупках.
Предложены институциональные преобразования: принятие единого федерального закона «О медицинских изделиях», расширение задач и функций Департамента регулирования обращения лекарственных средств и медицинских изделий Министерства здравоохранения Российской Федерации, внедрение цифрового «единого окна», переход к риск-ориентированному надзору и многофакторной системе закупок.
Научная новизна исследования состоит в разработке комплексной модели регулирования, учитывающей институциональные, правовые и экономические аспекты. Его практическая значимость – в возможности применения предложенных решений при реализации национальных стратегий импортозамещения и цифровизации.
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