Analysis of the Dossier of Corrective Actions

Many manufacturers of medical products often face non-standard situations during the registration procedure. It happens especially often when you are registering a medical product for the first time and don't have enough experience for it. That's why it's necessary to obtain new practical knowledge which is an important tool for success in the registration procedure.

It's quite common to receive a Notification of violation elimination from the registering authority and it makes many applicants worry. But it's no need to worry in such case as, according to the regulation, you have 30 business days to correct mistakes and bring the materials into compliance with the requirements of the supervisory authority. So you can't waste time and have to start working immediately!

First, familiarize yourself with violations described in the RZN Notification. Make a plan of actions and define the roles of responsible employees. For instance, an engineer works out the technical documentation, a certification specialist renews expired certificates, the testing facility conducts additional tests, etc. And finally, preparation of the Report of Corrective Actions and submission of the additional materials to Roszdravnadzor. The main thing is to apportion your time reasonably to meet the 30 day-deadline.

It's important to assess your capabilities for elimination of violations in the registration dossier first and then start the relevant actions.

If you've already prepared all amendments required for the Dossier of Corrective Actions and not sure of their correctness, we can reassure you and check all the executed documents. The analysis of completeness and authenticity of the documents contained in the dossier conducted by our experts will help find out the unaccounted details of violations. Our experts will work out a corrective actions scenario for you as well as whip the documents into shape which will help you continue the registration procedure successfully and obtain the long-expected MA.

The cost of the service amounts to ₽60,000, the period of work is 3 business days.

For analysis of the Dossier of Corrective Actions, you have to submit:
  • Notification with the described comments
  • Application for registration submitted to RZN
  • List of documents submitted to the relevant authority with remarks of acceptance
  • The set of registration documentation submitted to Roszdravnadzor

*The documents are submitted in full on an electronic data carrier.

If you have any questions about this procedure, we are ready to consult you by telephone: 8 (495)36-315-36 and give you some recommendations on meeting by inviting you to our office for a cup of coffee

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The most popular way to share experience in our practice is an offsite consultation which is not time-consuming and at reasonable price. Despite the low price, you'll get the most valuable and up-to-date information, which will help you solve the task.

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