Federal Service for Health Supervision

• FSBI Center for Monitoring and Clinical and Economic Expertise of Roszdravnadzor
• Federal State Budgetary Institution Information and Methodological Center for Expertise, Accounting and Analysis of Circulation of Medical Devices
• Federal State Budgetary Institution "All-Russian Scientific Research and Testing Institute of Medical Technology" of Roszdravnadzor

In accordance with part 5.1.3.2 of Chapter 2 of the Decree of the Government of the Russian Federation of June 30, 2004 N 323 “On approval of the Regulation on the Federal Service for Supervision of Healthcare” Roszdravnadzor - oversees compliance with medical organizations (regardless of ownership) that carry out medical activities, procedures for the provision of medical care and standards of medical care. Carries out state control over medicinal and pharmaceutical preparations. ^[2]

• 5.1.2. state control over the circulation of medical devices through;
• 5.1.2.1. conducting inspections of compliance by subjects of circulation of medical devices with rules in the field of circulation of medical devices;
• 5.1.3. state control of the quality and safety of medical activity through inspections;
• 5.1.3.1. the observance by the state authorities of the Russian Federation, local self-government bodies , state extra-budgetary funds, as well as medical and pharmaceutical organizations and individual entrepreneurs of the rights of citizens in the field of protecting the health of citizens, including accessibility for disabled people of infrastructure facilities and the services provided in this field;
• 5.1.3.2. compliance by medical organizations and individual entrepreneurs engaged in medical activities with the procedures for providing medical care and standards of medical care;
• 5.1.3.3. compliance by medical organizations and individual entrepreneurs engaged in medical activities with the procedures for conducting medical examinations, medical examinations and medical examinations;
• 5.1.3.4. compliance by medical organizations and individual entrepreneurs engaged in medical activities with the requirements for the safe use and operation of medical devices and their disposal (destruction);
• 5.1.3.5. compliance by medical workers, heads of medical organizations, pharmaceutical workers and heads of pharmacy organizations with the restrictions that apply to them when carrying out professional activities in accordance with the legislation of the Russian Federation;
• 5.1.3.6. organization and implementation of departmental control and internal control of the quality and safety of medical activity, respectively, by federal executive bodies, executive bodies of the constituent entities of the Russian Federation and bodies, organizations of state, municipal and private health systems;
• 5.1.4. federal state supervision in the field of circulation of medicines (in relation to medicines for medical use) by;
• 5.1.4.1. organization and conduct of inspections of compliance by subjects of drug circulation with the requirements established by the Federal Law "On Circulation of Medicines" and other normative legal acts of the Russian Federation adopted in accordance with it to preclinical studies of drugs, clinical trials of drugs, storage, transportation, dispensing, sale of drugs means, the use of drugs, the destruction of drugs;
• 5.1.4.2. organization and conduct of conformity checks of medicines in civil circulation, the established mandatory requirements for their quality;
• 5.1.4.3. organization and conduct of pharmacovigilance ;
• 5.1.4.4. applying, in the manner established by the legislation of the Russian Federation, measures to suppress identified violations of mandatory requirements and (or) eliminate the consequences of such violations, including making decisions on finding drugs for medical use in circulation, issuing orders to eliminate identified violations of mandatory requirements and attracting to liability of persons who committed such violations;
• 5.1.4 (1). selective quality control of medicines for medical use by:
• 5.1.4 (1) .1. processing information, mandatory provided by subjects of circulation of medicines for medical use, on the series, batches of medicines entering civilian circulation in the Russian Federation;
• 5.1.4 (1) .2. sampling of medicines for medical use from subjects of circulation of medicines for medical use in order to conduct tests for their compliance with the requirements of regulatory documents or regulatory documents;
• 5.1.4 (1) .3. making decisions on the further civil circulation of the corresponding medicinal product for medical use based on the results of the tests;
• 5.1.4 (1) .4. making a decision on transferring the medicinal product for medical use to serial selective quality control of medicinal products for medical use in the event of repeated detection of the quality of the medicinal product for medical use not meeting the established requirements and (if necessary) on checking the subject of the medicinal product for medical use;
• 5.1.4 (2). organization and (or) inspection of drug circulation entities for medical use for compliance with the rules of good laboratory practice, the rules of good clinical practice, the rules of good storage and transport of drugs, the rules of good distribution practice, and the rules of good pharmacy practice;
• 5.1.6.3. the implementation of regional programs for the modernization of health care in the constituent entities of the Russian Federation and the modernization of state institutions providing medical care, state institutions implementing measures to introduce information systems in healthcare
• 5.1.6.4. the reliability of the primary statistics provided by medical organizations and individual entrepreneurs engaged in medical activities;
• 5.1.7. control and supervision of the completeness and quality of the fulfillment by the state authorities of the constituent entities of the Russian Federation of the authority of the Russian Federation delegated to them to make annual cash payments to persons awarded with the “ Honorary Donor of Russia ” badge, with the right to send orders to eliminate the identified violations, as well as to hold accountable officials acting in the exercise of the delegated authority;
• 5.1.8. control over the activities of medical organizations providing psychiatric care , inpatient social services for people with mental disorders (in the provision of psychiatric care);
• 5.1.9. control over the use of narcotic drugs and psychotropic substances stored in first-aid kits on international ships and aircraft and on international trains;
• 5.1.10. state control over activities in the field of circulation of biomedical cellular products through $
• 5.1.10.1. organization and conduct of inspections of compliance by subjects of circulation of biomedical cellular products established by the Federal Law "On Biomedical Cellular Products" and other normative legal acts of the Russian Federation adopted in accordance with it the requirements for preclinical research, clinical research, production, sale, storage, transportation, import into Russian Federation, export from the Russian Federation, use, destruction of biomedical cell products;
• 5.1.10.2. the organization and conduct of checks of compliance of biomedical cellular products in circulation with quality indicators established by the regulatory documentation for a biomedical cellular product;
• 5.1.10.3. the application in the manner prescribed by the legislation of the Russian Federation of measures to prevent detected violations of the requirements of the Federal Law "On Biomedical Cellular Products" and (or) to eliminate the consequences of such violations, including deciding to suspend the circulation of biomedical cellular products and issuing instructions to eliminate the identified violations, as well as holding liable the persons who committed such violations;
• 5.1.11. selective quality control of biomedical cell products through the processing of information and sampling of biomedical cell products;
• 5.1.12.2. the withdrawal from circulation of falsified biomedical cell products or substandard biomedical cell products;
• 5.1.12.3. the destruction of falsified biomedical cell products or substandard biomedical cell products;
• 5.2.1. monitoring the assortment and prices of vital and essential medicines;
• 5.2.2. monitoring the safety of medical devices, recording side effects, adverse reactions when using medical devices, facts and circumstances that pose a threat to life and health when handling registered medical devices;
• 5.4 (1) .1. issues a permit for obtaining a license to import into the Russian Federation and export from the Russian Federation potent substances that are not precursors of narcotic drugs and psychotropic substances;
• 5.4 (1) .3. issues a certificate for the right to import (export) of narcotic drugs, psychotropic substances and their precursors;
• 5.4 (1) .4. issues a specialist certificate to persons who have received medical or pharmaceutical education in foreign countries;
• 5.4 (1) .5. issues a conclusion (permit) for the import into the Russian Federation and export from the Russian Federation of samples of human biological materials (with the exception of human biological material obtained during a clinical trial of a medicinal product for medical use, and human biological material obtained during a clinical trial of biomedical cell product, for its study for the purposes of this clinical study), hematopoietic stem cells, braids brain, donor lymphocytes for unrelated transplantation, germ cells and embryos;
• 5.4 (1) .6. conclusion (permitting document) for obtaining a license for the right to import into the Russian Federation and export from the Russian Federation organs and tissues of a person, blood and its components (with the exception of samples of human biological materials, hematopoietic stem cells, bone marrow, donor lymphocytes for the purpose of unrelated transplantation , germ cells and embryos);
• 5.5 (1). maintains the state register of medical devices and organizations (individual entrepreneurs) engaged in the production and manufacture of medical devices, and places it on the official website of the Service on the Internet;
• 5.5 (4). determines the list of organizations entitled to test (research) medical devices in order to register them within the framework of the Eurasian Economic Union, considers applications from organizations for inclusion in the specified list and informs them of the decision;
• 5.5 (5). issues permits for conducting clinical trials (studies) of medical devices;
• 5.5 (6). organizes inspections of the production of medical devices and conducts inspections of inspecting organizations;
• 5.8. carries out, in the prescribed manner, the audit of the activities of medical and pharmacy organizations, wholesale drug companies, other organizations and individual entrepreneurs operating in the field of health;
• 5.8 (2). reveals violations of the legislation of the Russian Federation on the circulation of medicines and in the field of health protection issues mandatory instructions and holds accountable for these violations, draws up protocols on administrative offenses and reviews cases in accordance with the legislation of the Russian Federation on administrative offenses;
• 5.8 (4). forms a commission to resolve conflicts of interest in the implementation of medical and pharmaceutical activities.

Employees of the state civil service have class ranks in groups of 1, 2 and 3 classes, which correspond to the military rank. Class ranks are established by Article 11 of the Federal Law of July 27, 2004 No. 79-FZ “On the State Civil Service of the Russian Federation”. ^[3] Employees' uniforms are not approved.

• March 25, 2004 - March 5, 2007 - R. U. Khabriev .
• March 9, 2007 - February 6, 2010 - N.V. Yurgel ^[4] .
• From February 9, 2010 - March 7, 2013 - E. A. Telnova .
• Since March 7, 2013 - M. A. Murashko ^[5] .

• Official site of Roszdravnadzor
• Official site of Federal State Institution Scientific Center ESMP