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Medical Device Regulations in Russia and Eurasian Union

    https://medicaldevicesinrussia.com/
    2. New guidance on quality management system requirements for the registration of medical devices. On February 9 th, 2022, the Russian government released regulation #135 ( link in Russian) and established rules for the inspection of quality …

Federal Service for Surveillance in Healthcare :: Main page

    https://roszdravnadzor.gov.ru/en
    - certificates of a specialist to persons with foreign medical or pharmaceutical education. 6. The Federal Service for Surveillance in Healthcare performs state registration of …

How to Register Medical Devices in Russia | RegDesk | Professional

    https://www.regdesk.co/register-medical-devices-russia/

    Medical device registration in Russia - a brief guide | MDRC

      https://mdrc-consulting.com/medical-device-registration-in-russia-a-brief-guide/
      The Medical Device Registration and Control Department makes decisions regarding registrations and denials of medical devices in Russia. It is also responsible for changes and modification approvals, suspension …

    Russia Medical Device Registration - Roszdravnadzor …

      https://arazygroup.com/medical-device-registration-russia/
      Medical Device Regulations and Classification in Russia. REGULATORY AUTHORITY: Federal Service for Surveillance in Healthcare (Rosdravnadzor or RZN). …

    State registration of medical devices and equipment

      http://medexpertpro.ru/en/
      Full support of the registration process for medical devices in Russia, the European Union and the EAEU countries. Your reliable partner in the registration of medical devices! ...

    Medical devices registration in Russia

      https://russiadevices.com/
      Registration of medical devices is a very rigorous process very similar to the one practiced in Europe. It involves many laboratory tests, clinical studies and document verifications, …

    Registration Process Medical Products in Russia

      https://devicemaster.eu/en/blog-en/initial-registration-process-of-medical-products-from-abroad-in-the-russian-federation/
      Moscow, 109074. To file the documents for state registration of medical device in electronic form, applicants need to be registered on the web-site: https://esia.gosuslugi.ru. For more information see following contacts: …

    MEDICAL DEVICE REGISTRATION IN RUSSIA

      http://www.rustandard.com/en/medical-device-registration-in-russia.html
      The registration of medical devices in Russia is regulated by the Decree of the Government of the Russian Federation No. 1416 of 27/12/2012. The certificate can be issued to the producer who is the importer, for the mass …

    Russian Regulation on Medical Device Batch Registration

      https://www.regdesk.co/russian-regulation-batch-registration/
      The first document issued in Russia is dedicated to the specific aspects of the medical devices` circulation in general and state registration of batches of medical …



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