Analysis of the Denial Dossier

Before entering on the market, all medical products are subject to be checked by the supervisory authority and should pass the procedure of compliance with safety requirements. Import, manufacturing, and sales of medical products are impossible without permits. Necessity and advantages of registration of medical products are due to the fact that you can act in the area of utilization of medical products only after obtaining all necessary documents. Strict control by the registering authority is specified for protection of people from low-quality medical products which can cause harm to human health and life.

Obtainment of the marketing authorisation shows that the product has passed all checks and may be used as intended.

But sometimes it happens that at one of the stages of registration it reveals that the quality and safety of properties and specifications of the medical product are not confirmed. Or the documents for the device submitted for registration are not complying with regulatory requirements. In this case, Roszdravnadzor makes a negative resolution concerning the further fate of the device and notifies the applicant on denial of registration.

But even in such case, keep your head up, there is a way out of any situation! The life of the medical product may be actualized if the registration procedure is passed again with correction of all previously specified violations. Of course, the applicant will bear some expenses: Additional payment of the state duty and elongation of the registration period. But optimists always aim at the result, and the result of this complicated path is MA obtainment!

By the way, the terms of preparation of the documents for the denial dossier can be sufficiently reduced if the specialist preparing them is familiar with the legal aspect of this area, knows how to promptly correct the mistakes in the documents to bring it to the logical end the first time.

Possible Causes of Denials of Registration of medical products
  • Violations in the documents submitted by the applicant are not corrected within the period of 30–50 business days in accordance with the RZN Notification.
  • As a result of the I stage of the assessment, quality and safety of the medical product are not confirmed.
  • As a result of the II stage of the assessment, safety and clinical efficiency of the medical product are not confirmed.

If you've prepared the documents for the denial dossier on your own, we recommend you to consult the skilled experts in this area before submitting them to Roszdravnadzor to assure yourself in the further successful passing of the registration process.

We can propose you to conduct analysis of the prepared documents and to give our recommendations. To di this, it's necessary to provide us with:

  • Application and the package of documents in case they are submitted to RZN for the first time (the content of the package should comply with the list with acceptance note)
  • Notification of denial of registration and expert report as a result of quality and safety assessment.
  • Report of corrective actions taken and the package of documents with corrections.

The cost of the service is ₽60,000, the term of analysis is 10 business days.

If it's not possible for you to prepare the documents for the denial dossier by yourself and continue the registration process, we are ready to provide competent support!

Contact us