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Регистрация – важнейший этап в цикле обращения медицинского изделия, без которого не возможна его продажа и эксплуатация. Мы предлагаем комплекс услуг для регистрации медицинских изделий различных классов и готовы оказать содействие на всех этапах регистрации изделия. Наша команда обладает уникальным опытом регистрации широкого спектра медицинских изделий в соответствии с актуальными нормами законодательства Российской Федерации и ЕАЭС . Это позволяет нам оказывать помощь на любых этапах регистрации изделия – ввозе, разработке и изменении документации в соответствии с текущими требованиями, проведении лабораторных испытаний, координации работ и внесении изменений в регистрационное досье.

Registration is one of the most important stage in the circulation cycle of a medical device, without which its sale and operation is impossible. We offer a range of services for the registration of medical devices of various classes and are ready to assist at all stages of product registration. Our team has unique experience in registering a wide range of medical devices in accordance with the current legislation of the Russian Federation and the EAEU. This allows us to provide assistance at any stage of product registration – import, development of documentation in accordance with current requirements, laboratory tests, coordination of work and amendments to the original documentation to bring it into line with the legislation, amendments to the registration dossier.

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