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  • New Medical Device Registration Rules in Russia 2025 - UCEC . . .
    What are the main changes to medical device registration in Russia from March 2025? The key changes include simplified procedures for low-risk devices (Classes 1 and 2a), introduction of electronic document management through an applicant's personal account, requirement for expert evaluations before document submission, ability to register multiple models in one registry entry, and mandatory
  • Medical Device Registration - boro. ru
    What is included in the registration process Evaluation of documents for the possibility to register it as a medical device; Import medical device samples
  • Registration of medical devices according to the Russia rules . . .
    What is registration and why is it necessary to register medical devices? Following paragraph 4 of Article 38 of the Federal Law N 323-FZ “On the Basics of Protecting the Health of Citizens in the Russian Federation” dated November 21, 2011, the circulation of medical devices is allowed on the territory of the Russian Federation only if they were registered in the procedure established by
  • Medical Device Registration - Элмас
    2 Stage 1 of expert review Analysis of the prepared and submitted dossier The result of the first stage of the expert review is either the issue of the permission authorizing clinical trials or rejection of the registration application
  • AsiaMedConsult
    AsiaMedConsult LLC is a team of experts with rich experience in the field of registration of medical devices of all types and risk classes We will help you obtain all the necessary documents to bring your product to the markets of the Russian Federation and the EAEU countries (Armenia, Belarus, Kazakhstan, Kyrgyzstan, Russia)
  • MECRA | Registration of medical devices
    Medical Equipment Competent Registration Agency (MEСRA) – this abbreviation provided the basis for our company name We provide assistance and constantly increase our competence in registering medical devices
  • Registration of medical devices in Russia according to the . . .
    Registration Agency "Medical Systems" is a team of specialists in the field of registration of medical devices, both Russian and foreign, with knowledge of English We will help you bring your products to the market of the Russian Federation and the EAEU





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