• ОФОРМЛЕНИЕ РЕГИСТРАЦИОННЫХ УДОСТОВЕРЕНИЙ ДЛЯ МЕДИЦИНСКИХ ИЗДЕЛИЙ БЕЗ ПОСРЕДНИКОВ
  • INFO@GOSZDRAVNADZOR.RU
115487, город Москва

ул. Нагатинская, д. 16

+7 (495) 199-72-57

с 10:00 до 20:00

Procedure for making changes to registration dossier of Roszdravnadzor

Регистрация медицинских изделий в Росздравнадзоре

Changes to registration documents (dossier)

The procedure for making changes to registration documents is carried out if it is necessary to make changes to the set of registration documents and if the changes made do not relate to the information specified on the registration certificate form.

The procedure for making changes to registration documents is carried out if it is necessary to make changes to the set of registration documents and if the changes made do not relate to the information specified on the registration certificate form.

The need to make changes can arise for a variety of reasons. It should be remembered that this procedure is official and all the features of its implementation are reflected in the Decree of the Government of the Russian Federation of December 27, 2012 No. 1416.


Expertise when making changes to registration documents:

If it is necessary to make changes to the technical and operational documentation, the changes are made based on the results of an examination carried out in a manner similar to the procedure for conducting an examination of the quality, effectiveness and safety of a medical device for its state registration in accordance with clause 21 of the Rules.

In accordance with Article 333.32.2 of the Tax Code of the Russian Federation for hosting the quality of the examination, the effectiveness and safety of a medical device (depending on the potential risk of a class of its application) when amending the documents contained in the registration dossier of medical products state fee shall be paid in the following amounts:

  • Hazard class 1 — 20,000 rubles;
  • Hazard class 2a — 30,000 rubles;
  • Hazard class 2b — 40,000 rubles;
  • Hazard class 3 — 55,000 rubles.

For making changes to the documents contained in the registration dossier of a medical device that do not require an examination of the quality, effectiveness and safety of a medical device, the state fee is 1,500 rubles.


Process for making changes to registration documents:

  • Preparing official statement (prepared in accordance administrative regulations) in Roszdravnadzor to amend the registration documents or registration dossier;
  • Payment of state fees in accordance with the tariff;
  • Necessary tests: technical, toxicological, clinical
  • Submission of the collected documentation package together with a receipt for payment of the state fee to Roszdravnadzor.
  • Sending clarifying requests to Roszdravnadzor
  • Maintenance of the procedure for making changes to registration documents (dossier)
  • Obtaining an order to amend registration documents (dossier)
  • Transfer of a new set of documentation to the customer (applicant).

Experts who are ready to solve your problem:

  • Project manager for work with clients and his assistant,
  • Specialist in the development of documentation and his assistant,
  • Translators,
  • Testing expert (technical, toxicological and clinical trials),
  • Courier.

Here you can see the full price list for our services.


Since 2011, Goszdravnadzor has been professionally engaged in the provision of services for the registration of permits. During our activity, we managed to study this direction down to the smallest nuances. Today we can confidently declare that we are one of the leaders in the development and execution of permits.


Benefits of cooperation with Goszdravnadzor:

Command with a common goal

The Goszdravnadzor company as an organism united by a common goal — to do the work so that the client is satisfied, turned to us again, and advised colleagues. An optimally selected staff of employees successfully resolves any issues during the performance of work, moreover, it does it without involving other performers. The client will not “lose” his project manager, as our staff turnover is minimal.

In words, in a contract and in work

The obvious superiority of Goszdravnadzor over competitors is transparent and honest interaction with the customer. After receipt of the offer, you can be sure that the price and terms of the provision of services in the final there. During the entire period of work, there has not yet been a case when the cost of the work agreed with the customer was overstated or changed. If mistakes are made on our part, we will compensate the costs of correcting them at our own expense. The client makes payment in stages — upon completion of the work.

Guaranteed successful completion of the project

Until the conclusion of the contract, specialists with specialized education conduct a thorough analysis of the available documentation for products or equipment. In the absence of the necessary information, we will certainly notify the customer about this. In this way, we reduce the risk of a negative result and also reduce the turnaround time.

Experience. Knowledge. Authority.

Since 2011, the Goszdravnadzor company has been carrying out projects of varying complexity and focus. We have worked with both simple (one-component) medical devices with a low hazard class and high-tech medical equipment. Extensive knowledge of experts and well-established relations with government agencies allow you to work faster, draw up documentation the first time, and carry out tests without a headache for the customer.