Roszdravnadzor – how to use authority website?

The Federal Service for Surveillance in Healthcare (Roszdravnadzor) belongs to the executive authorities and performs control and supervisory functions in the field of organizing and ensuring the protection of public health. When registering medical devices (MD), Roszdravnadzor relies on the Decree of the Government of the Russian Federation No 1416 “On Approval of the Rulesr State Registration of Medical Devices” dated December 27, 2012.

At the entrance to the Roszdravnadzor website https://roszdravnadzor.gov.ru/, we are greeted by areas of activity for which information can be obtained. During the registration process, we need a section “Medical devices (Медицинские изделия)”

In this section you can find out:

  1. All relevant information on the issued and applied regulatory documents;
  2. News in the field of registration and circulation of medical devices;
  3. Contacts for communication with representatives of Roszdravnadzor.

By going to the “Applicant (Заявитель)” subsection, you can find answers to all questions, as well as a detailed algorithm of actions for passing the MD registration procedure.

The main page of the site has a section “Services (Сервисы)”.

What information can be found in the “Services” section? Let’s consider the services used in the product registration process.

  1. Nomenclature classification of medical devices by types

This service will help in formulating the name of the product and its purpose.

  1. Information on the course of consideration of applications from legal entities/ individuals

In this service, you can track the incoming number from Roszdravnadzor by your outgoing number. This number is required for tracking import permits, registration dossiers, newsletters, etc.

  1. Information on the issued permits for the import of medical devices into the territory of the Russian Federation

In this service, you can view the received permits for the import of medical devices by their name or by the name of the applicant organization.

  1. Automated system “Import of unregistered medical devices”

This service is intended to optimize the procedure for providing information on the import of unregistered medical devices (MD) provided for by the Features circulation of medical items, including the state registration of a series (batch) of a medical device, approved by the Decision of the Government of the Russian Federation No. 430 of April 3, 2020.

  1. Medical device newsletters

In this service you can view information letters issued by Roszdravnadzor on the following topics: non-compliance with established requirements; about unregistered medical device; medical device safety; quality of medical devices, etc.

  1. Register of issued permits for clinical evaluation of MD and a list of medical organizations conducting clinical evaluation of MD.

In these services, you can get information about the issued permits for clinical testing, as well as a list of testing laboratories (TL) that can conduct them. Before contacting testing laboratory, it is recommended to check its scope of accreditation through the official Internet resource of the Federal Accreditation Service.

  1. Information about testing laboratories and organizations entitled to conduct tests of medical devices in order to register them within the Eurasian Economic Union.

In these sections, you can get information about TL that have the right to test products for the purpose of registration within the Eurasian Economic Union No. 46 “On the Rules for the Registration and Examination of the Safety, Quality, and Efficiency of Medical Products” dated February 12, 2016.

  1. Information on the status of consideration of documents submitted for registration of medical devices.

This section will help you track all information about the registration of medical devices by the incoming number from Roszdravnadzor. Information that can be tracked during the registration process:

  1. Date of acceptance of the application;
  2. Responsible executor and his contacts;
  3. Registration start date;
  4. Date of sending the assignment for expertise (1st step);
  5. Dates of the beginning and the end of clinical testing;
  6. Date of sending the assignment for expertise (2nd step);
  7. Requests for materials and information at all stages of registration and its numbers;
  8. Refusal to register the medical device and its number;
  9. Registration Certificate of medical device and its number.

9.State register of medical devices and organizations (sole proprietor) engaged in the production and manufacture of medical devices

This register contains information on the issued registration certificates (number and date of registration, validity period, names and addresses of the manufacturer and applicant, etc.) Also, you can see the changes made to registration certificates.

References

  1. Federal Service for Surveillance in Healthcare, available at: https://roszdravnadzor.gov.ru/, свободный (accessed: 11.2020);
  2. National accreditation system, available at: https://fsa.gov.ru/, свободный (accessed: 11.2020);