Registration Denial Dossier

There are frequent cases in the sphere of the state registration of medical products when it's necessary to form a Registration Denial Dossier. It always happens due to lack of experience!

But even if you've received a Denial of Registration, keep your head up! To prevent such cases in the future, it's necessary to resolve the most important question: how to register a medical product (on your own or employing the services of consulting companies)? The result of actions related to obtainment of such important permit as the marketing authorisation for a medical product depends on this basic question.


There are three types of applicants:

  • Some have enough experience and knowledge to conduct the MP registration procedure on their own but they are not familiar with all specific aspects of this procedure and sometimes they use the consulting and informational services third-party organisations
  • The others just don't have enough time to carry out this procedure and they need a turnkey service
  • The third ones have faced the medical registration procedure for the first time and don't know what to start with, sometimes they find intermediaries providing this service with lack of competence and lose their money and time


To avoid receiving the new Denial of Registration, it's necessary to do everything right with all solemnity and attention.

But if you've decided to carry out the registration process on your own, our recommendations will be helpful.


The Most Frequent Causes of Denials


  • The information of the medical product is not provided in full
  • The period of submission of lacking documents (30 days) has expired
  • The violations found by the Roszdravnadzor are not corrected by the applicant within the specified term, and many others


Also sometimes the expert facility informs about impossibility to conduct clinical trials of the medical product or about negative conclusion of assessment results of which don't comply with specified parameters and standards.


If you've faced such situation and don't know what to do next, don't worry: Everything can always be made right!


It can take from 14 up to 30 days to form the Registration Denial Dossier. The cost of this service is calculated individually and depends on the scope of the violations described in the Registration Denial Notification as well as on the applicant's timeliness of submittal of additional materials


Knowledge possessed by our experts will help you to reach the desired result in time!

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