Services
Registration of medical products in Kazakhstan constitutes an important and obligatory step in ensuring the safety and quality of medical products available to the consumer. Through the registration process, medical product manufacturers can demonstrate that their products meet the highest standards of safety and efficacy. Thus, the manufacturer gets the right to sell its goods in the Kazakhstan market, which is a growing and dynamic market with significant potential for growth.
Registration of medical products in Kazakhstan
Registration of medical products with the EAEU countries
Registration of medical products in Kazakhstan
Documentation development and test organization
State registration of medical products in Belarus
State registration of medical products in Kyrgyzstan
State registration of medical products in Armenia
Registration of medical products in the Russian Federation
Equipment of test centers
Organization of medical product testing
Services
Registration of medical devices in the Eurasian Economic Union (EAEU) can be carried out at the choice of the applicant either in one or several member states of the Union. This means that manufacturers and importers have the flexibility to choose in which EAEU Member State they wish to register their medical device. This process, known as mutual recognition, helps simplify the process for manufacturers and importers and ensures that medical devices are available to patients throughout the EEU.
Registration of medical products with the EAEU countries
Registration of medical products with the EAEU countries
Registration of medical products in Kazakhstan
Documentation development and test organization
State registration of medical products in Belarus
State registration of medical products in Kyrgyzstan
State registration of medical products in Armenia
Registration of medical products in the Russian Federation
Equipment of test centers
Organization of medical product testing
Services
In the process of registering a medical device, the manufacturer must submit a registration dossier to the authorized body. Proper quality of documents and the absence of false information in them guarantees the successful completion of this procedure in the shortest possible time, which is the goal of our work. After the registration dossier is submitted to Roszdravnadzor, we also continue to support the registration process until the client receives a registration certificate.
Registration of medical products in the Russian Federation
Registration of medical products with the EAEU countries
Registration of medical products in Kazakhstan
Documentation development and test organization
State registration of medical products in Belarus
State registration of medical products in Kyrgyzstan
State registration of medical products in Armenia
Registration of medical products in the Russian Federation
Equipment of test centers
Organization of medical product testing
Services
Pursuant to Resolution of the Council of Ministers of the Republic of Belarus No. 1269, state registration of medical products and medical equipment is a procedure for admission to production, realization and medical use of products for medical purposes and medical equipment manufactured in the Republic of Belarus or coming from outside the Republic of Belarus, which are recognized as complying with the safety, efficiency and quality requirements for human beings established in the Republic of Belarus.
State registration of medical products in Belarus
Registration of medical products with the EAEU countries
Registration of medical products in Kazakhstan
Documentation development and test organization
State registration of medical products in Belarus
State registration of medical products in Kyrgyzstan
State registration of medical products in Armenia
Registration of medical products in the Russian Federation
Equipment of test centers
Organization of medical product testing
Services
Pursuant to Law No. 166 of August 2, 2017 "On Circulation of Medical Products", the registration of medical products is a procedure to confirm the compliance of a medical product with the requirements of quality, safety and efficiency for the purpose of circulation thereof. Assessment of the quality and safety of medical products is carried out by the Division for Quality Assessment of Drugs and Medical Product of the Department of Drugs and Medical Products under the Ministry of Health and Social Development of the Republic of Kyrgyzstan, which constitutes the authorized body.
State registration of medical products in Kyrgyzstan
Registration of medical products with the EAEU countries
Registration of medical products in Kazakhstan
Documentation development and test organization
State registration of medical products in Belarus
State registration of medical products in Kyrgyzstan
State registration of medical products in Armenia
Registration of medical products in the Russian Federation
Equipment of test centers
Organization of medical product testing
Services
Today, the circulation of medical equipment and medical devices in the territory of Armenia is allowed without state registration. However, due to Armenia's accession to the EAEU, it is planned to update local legislation and develop the entire registration system.
State registration of medical products in Armenia
Registration of medical products with the EAEU countries
Registration of medical products in Kazakhstan
Documentation development and test organization
State registration of medical products in Belarus
State registration of medical products in Kyrgyzstan
State registration of medical products in Armenia
Registration of medical products in the Russian Federation
Equipment of test centers
Organization of medical product testing
Нормативная документация
Services
Registration of medical products with the EAEU countries
Registration of medical products in Kazakhstan
Documentation development and test organization
State registration of medical products in Belarus
State registration of medical products in Kyrgyzstan
State registration of medical products in Armenia
Registration of medical products in the Russian Federation
Разработка технической и эксплуатационной документации на медицинские изделия является основополагающим шагом в обеспечении их безопасности и эффективности. Качественная техническая и эксплуатационная документация, которая отвечает требованиям нормативных документов, является важнейшим источником информации о медицинском изделии и имеет ключевое значение для уполномоченных органов при принятии решения о государственной регистрации.
Equipment of test centers
Documentation development and test organization
Organization of medical product testing
Нормативная документация
Services
Registration of medical products with the EAEU countries
Registration of medical products in Kazakhstan
Documentation development and test organization
State registration of medical products in Belarus
State registration of medical products in Kyrgyzstan
State registration of medical products in Armenia
Registration of medical products in the Russian Federation
The testing/research of medical products is a critical step in ensuring their safety and efficiency. In cases where activities such as technical tests, toxicological studies, electromagnetic compatibility tests and clinical trials are required, they shall be carried out in full compliance with regulatory requirements and by centers recognized as accredited to do so.
Equipment of test centers
Organization of medical product testing
Organization of medical product testing
Нормативная документация
Services
Registration of medical products with the EAEU countries
Registration of medical products in Kazakhstan
Documentation development and test organization
State registration of medical products in Belarus
State registration of medical products in Kyrgyzstan
State registration of medical products in Armenia
Registration of medical products in the Russian Federation
Besides our own technical and toxicology laboratories, the Electrontest Group also incorporates the "Center for Technical Safety of Materials, Equipment and Complex Systems" (CTS MOS), specializing in the design and manufacture of out-of-the-box, unique test equipment. CTB MOS is a manufacturing company engaged in the development and production of test equipment for technical testing of various types of products, including medical products and products related to all technical regulations of the Customs Union.
Equipment of test centers
Equipment of test centers
Organization of medical product testing
Нормативная документация
Services
Registration of medical products with the EAEU countries
Registration of medical products in Kazakhstan
Documentation development and test organization
State registration of medical products in Belarus
State registration of medical products in Kyrgyzstan
State registration of medical products in Armenia
Registration of medical products in the Russian Federation
Equipment of test centers
Organization of medical product testing
Registration of medical products in Kazakhstan constitutes an important and obligatory step in ensuring the safety and quality of medical products available to the consumer. Through the registration process, medical product manufacturers can demonstrate that their products meet the highest standards of safety and efficacy. Thus, the manufacturer gets the right to sell its goods in the Kazakhstan market, which is a growing and dynamic market with significant potential for growth.
Registration of medical products in Kazakhstan
Регистрация медицинских изделий в Евразийском экономическом союзе (ЕАЭС) может быть осуществлена по выбору заявителя либо в одном, либо в нескольких государствах-членах Союза. Это означает, что производители и импортеры имеют возможность гибко выбирать, в каком государстве-члене ЕАЭС они хотят зарегистрировать свое медицинское изделие. Этот процесс, известный как взаимное признание, помогает упростить процесс для производителей и импортеров и гарантирует доступность медицинских изделий для пациентов по всему ЕАЭС.
Регистрация медицинских изделий в странах ЕАЭС
В процессе осуществления регистрации медицинского изделия, производителю необходимо представить уполномоченному органу регистрационное досье Надлежащее качество документов и отсутствие в них недостоверных сведений гарантирует успешное прохождение данной процедуры в минимальные сроки, что и является целью нашей работы. После подачи регистрационного досье в Росздравнадзор, мы также продолжаем сопровождение процесса регистрации до момента получения клиентом регистрационного удостоверения.
Государственная регистрация медицинских изделий
в Российской Федерации
в Российской Федерации
Согласно Постановлению совета министров республики Беларусь № 1269, государственная регистрация изделий медицинского назначения и медицинской техники – процедура допуска к производству, реализации и медицинскому применению изделий медицинского назначения и медицинской техники, производимых в Республике Беларусь или поступающих из-за ее пределов, которые признаны соответствующими требованиям по безопасности, эффективности и качеству для человека, установленным в Республике Беларусь.
Государственная регистрация медицинских изделий в Республике Беларусь
В соответствии с законом № 166 Об обращении медицинских изделий «Об обращении медицинских изделий» от 2 августа 2017 года, регистрация медицинских изделий — процедура подтверждения соответствия медицинского изделия требованиям качества, безопасности и эффективности с целью его обращения. Оценку качества и безопасности медицинских изделий осуществляет Управление по оценке качества лекарственных средств и медицинских изделий Департамента лекарственных средств и медицинских изделий при Министерстве здравоохранения и социального развития Кыргызской Республики, являющееся уполномоченным органом.
Государственная регистрация медицинских изделий в Кыргызской Республике
На сегодняшний день обращение медицинской техники и изделий медицинского назначения на территории Армении разрешены без государственной регистрации. Однако, по причине вступления Армении в ЕАЭС, планируется обновление локального законодательства и разработка всей системы регистрации.
Государственная регистрация медицинских изделий в Республике Армения
Разработка технической и эксплуатационной документации на медицинские изделия является основополагающим шагом в обеспечении их безопасности и эффективности. Качественная техническая и эксплуатационная документация, которая отвечает требованиям нормативных документов, является важнейшим источником информации о медицинском изделии и имеет ключевое значение для уполномоченных органов при принятии решения о государственной регистрации.
Разработка технической
и эксплуатационной документации
и эксплуатационной документации
Проведение испытаний/исследований медицинских изделий является важнейшим шагом в обеспечении их безопасности и эффективности. В случаях необходимости проведения таких мероприятий, как технические испытания, токсикологические исследования, тесты на электромагнитную совместимость и клинические испытания, они должны проводиться в полном соответствии с нормативными требованиями и аккредитованными на это центрами.
Организация испытаний медицинских изделий
В дополнение к нашим собственным технической и токсикологической лабораториям, в состав группы компаний Электронтест также входит «Центр технической безопасности материалов, оборудования и сложных систем» (ЦТБ МОС), специализируется на разработке и изготовлении нестандартного, уникального испытательного оборудования. ЦТБ МОС является производственной компанией, обеспечивающей разработку и производство испытательного оборудования для проведения технических испытаний различных видов продукции, включая медицинские изделия и продукцию, относящуюся ко всем техническим регламентам Таможенного союза.
Оснащение испытательных центров
Astana, st. Anet baba, 9/3
+7 (776) 326 2500
+7 (702) 999 1964
+7 (701) 419 2225
+7 (702) 999 1964
+7 (701) 419 2225
Our work is based on a deep knowledge of regulatory documents, an understanding of the physics of processes in medical devices, the high qualification of our experts and, most importantly, on our own test base.
Company group
Our services
Contacts
For request:
electrontest.kz@gmail.com
electrontest.kz@gmail.com
