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Regulatory framework for federal service for surveillance in healthcare

Federal Service for Surveillance in Healthcare (Roszdravnadzor) was established by the President of the Russian Federation in Decree on March 9, 2004 № 314 “On the System and Structure of the Federal Executive Bodies” and is a federal executive body responsible for control and supervision of the Healthcare system.

Roszdravnadzor is subordinate to the Ministry of Health of the Russian Federation and guided by the Russian Federation Constitution, federal constitutional laws, federal laws, acts of the President of the Russian Federation and State Government, international agreements, acts of the Ministry of Health of the Russian Federation and the Regulation stated in Decree dated June 30, 2004 № 323 “On the Federal Service for Surveillance in Healthcare”.

The Federal Service for Surveillance in Healthcare operates directly or through its regional offices in cooperation with other federal agencies, state executive bodies, local authorities, public associations and other institutions.

The structure of the Federal Service for Surveillance in Healthcare currently includes the central head office (9 departments), 80 regional offices in constituent entities of the Russian Federation, 1 interregional office and 3 federal state budget institutions. 

Roszdravnadzor exercises the following powers:

1. State control and supervision of:

- medical devices circulation;

- quality and safety of medical practice by carrying out inspections and audits;

- circulation of medicines

- pricing for medicines included into the list of vital and essential medicines;

- Execution of the Russian Federation regional healthcare modernization programs and measures to modernize public healthcare institutions and state institutions   implementing healthcare information systems deployment and upgrade in the Russian Federation constituent entities;

- Reliability of primary statistics presented by medical institutions and individual medical entrepreneurs.

2. Control and supervision of State government bodies of the Russian Federation constituent entity regarding annual payments to persons awarded the “Honorable Donor of Russia” title.  Roszdravnadzor is in charge of identifying violations and initiation of the prosecution of local officials responsible for failure to exercise the delegated authority.

3. The Federal Service for Surveillance in Healthcare performs the following:

- monitoring of the list of vital and essential medicines and their prices;

- monitoring of medical devices safety, registering side effects and adverse reactions, as well as facts and circumstances, related to the circulation of registered medical devices, that might be  posing threat to  life and health of people.

4. Licensing of certain types of practices within the competence of the Service. 

5. The Federal Service for Surveillance in Healthcare issues:

- permits for transit of superpotent substances which are not precursors of narcotic drugs and psychotropic substances through the territory of the Russian Federation;

- permits for import of medical devices into the Russian Federation for the purposes of state registration;

- certificate for import (export) of narcotic drugs, psychotropic substances and their precursors;

- certificates of a specialist to persons with foreign medical or pharmaceutical education.

6. The Federal Service for Surveillance in Healthcare performs state registration of medical devices.

7. The Federal Service for Surveillance in Healthcare maintains the state registry of medical devices and institutions manufacturing medical devices;

8. Service publishes the information about the decisions made based on results of medicines safety monitoring;

9. The Federal Service for Surveillance in Healthcare performs inspections of Healthcare institutions;

10. The Federal Service for Surveillance in Healthcare has reception hours, provides timely and complete processing of citizens appeals;

11. The Federal Service for Surveillance in Healthcare performs other functions subject to the Regulation on Roszdravnadzor, as well as functions stipulated by federal laws, regulatory acts of the President of the Russian Federation or the Government of the Russian Federation.

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