Medical Device Registration
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Medical Device Registration

Offering comprehensive, professional, and expedited support for medical device registration.

Medical Device Registration

End-to-end Support for Medical Device Registration

Our dedicated regulatory department manages the entire process of medical device registration. Our team of experts and professionals oversee each stage, from document preparation to robust engagement with the expert community. To date, our registration department has secured over 350 authorizations within the Russian and CIS markets.

Execution work stages

Stage 1

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Request for a technical file, development of technical conditions, formation of a registration dossier

Stage 2

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Technical, toxicological and clinical trials

Stage 3

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 Expertise conducting by FSBI

ALL-RUSSIAN RESEARCH AND TESTING INSTITUTE OF MEDICAL TECHNOLOGY or FSBI TsMIKEE of Roszdravnadzor

Stage 4

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Successful expertise completion

Advantages

<h3>Skillful Team</h3> <ul> <li>Our team comprises seasoned specialists who have successfully secured over 350 authorizations</li> <li>Our professionals maintain close collaboration with the Federal Service for Surveillance in Healthcare</li> <li>Our experts annually participate in advanced training programs for continuous learning and growth</li> </ul>

Skillful Team

  • Our team comprises seasoned specialists who have successfully secured over 350 authorizations
  • Our professionals maintain close collaboration with the Federal Service for Surveillance in Healthcare
  • Our experts annually participate in advanced training programs for continuous learning and growth
<h3>End-to-End Support</h3> <ul> <li>We facilitate the submission of dossiers to the Federal Service for Surveillance in Healthcare</li> <li>We ensure meticulous verification of the registration dossierr</li> <li>We efficiently address and rectify any identified concerns or comments</li> <li>We secure permissions necessary to conduct clinical trials</li> <li>We manage the submission of clinical trial results to the Federal Service for Surveillance in Healthcare</li> </ul>

End-to-End Support

  • We facilitate the submission of dossiers to the Federal Service for Surveillance in Healthcare
  • We ensure meticulous verification of the registration dossierr
  • We efficiently address and rectify any identified concerns or comments
  • We secure permissions necessary to conduct clinical trials
  • We manage the submission of clinical trial results to the Federal Service for Surveillance in Healthcare
<h3> Facilitating Market Entry</h3> <ul> <li>We cooperate with top-tier distributors</li> <li>We coordinate supply arrangements with the largest pharmacy chains</li> <li>We offer comprehensive marketing support to promote product visibility and uptake</li> </ul> <br>

Facilitating Market Entry

  • We cooperate with top-tier distributors
  • We coordinate supply arrangements with the largest pharmacy chains
  • We offer comprehensive marketing support to promote product visibility and uptake