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<article xmlns:mml="http://www.w3.org/1998/Math/MathML" xmlns:xlink="http://www.w3.org/1999/xlink" xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance" article-type="research-article" dtd-version="1.1d1" xml:lang="en"><front><journal-meta><journal-id journal-id-type="publisher">Problems of Social Hygiene, Public Health and History of Medicine</journal-id><journal-title-group><journal-title>Problems of Social Hygiene, Public Health and History of Medicine</journal-title></journal-title-group><issn publication-format="print">0869-866X</issn><issn publication-format="electronic">2412-2106</issn><publisher><publisher-name>Joint-Stock Company Chicot</publisher-name></publisher></journal-meta><article-meta><article-id pub-id-type="publisher-id">1411</article-id><article-id pub-id-type="doi">10.32687/0869-866X-2025-33-1-65-72</article-id><article-categories><subj-group subj-group-type="heading"><subject>Неопределен</subject></subj-group></article-categories><title-group><article-title>The characteristics of customs official registration of medical articles under importation into the Russian Federation</article-title></title-group><contrib-group><contrib contrib-type="author"><name name-style="western"><surname>Tonkonog</surname><given-names>V V</given-names></name><email>vikatonkonog79@mail.ru</email><xref ref-type="aff" rid="aff-1"/></contrib></contrib-group><aff id="aff-1">The Federal State Budget Educational Institution of Higher Education “The Admiral F. F. Ushakov State Maritime University”, 353924, Novorossiysk, Russia</aff><pub-date date-type="epub" iso-8601-date="2025-04-16" publication-format="electronic"><day>16</day><month>04</month><year>2025</year></pub-date><volume>33</volume><issue>1</issue><history><pub-date date-type="received" iso-8601-date="2025-04-16"><day>16</day><month>04</month><year>2025</year></pub-date><pub-date date-type="accepted" iso-8601-date="2025-04-16"><day>16</day><month>04</month><year>2025</year></pub-date></history><permissions><copyright-statement>Copyright © 2025,</copyright-statement><copyright-year>2025</copyright-year></permissions><abstract>&lt;p&gt;The article considers characteristics of customs official registration of medical articles under their import into the Russian Federation. The actuality of issue is conditioned by increasing need in modernization of health care and supply of population with high-quality medical articles. The main attention is paid to analysis of actual legislative and normative acts regulating this process and to discover characteristics occurring at stages of registration, control and certification of medical articles. The key stages of customs official registration are investigated including preparation of necessary documentation and interaction with state agencies. The attention is paid to changes made to legislation in the light of global challenges and needs of national market. In conclusion, causes are presented having critical importance for observance of customs formalities during transportation of medical articles.&lt;/p&gt;</abstract><kwd-group xml:lang="en"><kwd>medical articles</kwd><kwd>import procedure</kwd><kwd>state registration</kwd><kwd>customs official registration</kwd><kwd>state regulation</kwd></kwd-group><kwd-group xml:lang="ru"><kwd>медицинские изделия</kwd><kwd>порядок ввоза</kwd><kwd>государственная регистрация</kwd><kwd>таможенное оформление</kwd><kwd>государственное регулирование</kwd></kwd-group></article-meta></front><body></body><back><ref-list><ref id="B1"><label>1.</label><mixed-citation>Nikolaeva V. Import of medical devices in Russia. ATTEK Journal. Available at: https://www.centrattek.ru/info/import/ (accessed 05.21.2024) (in Russian).</mixed-citation></ref><ref id="B2"><label>2.</label><mixed-citation>Tonkonog V. V. Issues of formation and functioning of the common market of medical equipment and products within the framework of the Eurasian Economic Union: legal aspect. Problems of Social Hygiene, Health Care and the History of Medicine. 2024;32(4):778–4 (in Russian).</mixed-citation></ref><ref id="B3"><label>3.</label><mixed-citation>Tonkonog V. V. Topical issues of mandatory labeling of certain types of medical devices. Problems of Social Hygiene, Health Care and the History of Medicine. 2024;32(5):918–23 (in Russian).</mixed-citation></ref><ref id="B4"><label>4.</label><mixed-citation>Decree of the Government of the Russian Federation dated December 27, 2012 No. 1416 “On approval of the Rules for state registration of medical devices” (with amendments and additions). Garant. Available at: https://base.garant.ru/70291692/?ysclid=m20chxsbc8559492048 (accessed 09.23.2024) (in Russian).</mixed-citation></ref><ref id="B5"><label>5.</label><mixed-citation>Federal Law “On Technical Regulation” dated 12.27.2002 No. 184-FZ (latest edition). ConsultantPlus. Available at: https://www.consultant.ru/document/cons_doc_LAW_40241/?ysclid=m20cuaef57791039241 (accessed 09.23.2024) (in Russian).</mixed-citation></ref><ref id="B6"><label>6.</label><mixed-citation>Resolution of the Government of the Russian Federation No. 2425 dated December 23, 2021 “On approval of the Unified List of products subject to mandatory Certification and the Unified List of products subject to Declaration of Conformity, Amendments to Resolution of the Government of the Russian Federation No. 2467 dated December 31, 2020 and Invalidation of Certain Acts of the Government of the Russian Federation” (with amendments and additions). Garant. Available at: https://www.consultant.ru/document/cons_doc_LAW_40241/?ysclid=m20cuaef57791039241 (accessed 09.23.2024) (in Russian).</mixed-citation></ref><ref id="B7"><label>7.</label><mixed-citation>Decree of the Government of the Russian Federation dated 12.01.2009 No. 982 (as amended on 07.04.2020) “On approval of a single list of products subject to mandatory certification and a single list of products whose conformity is confirmed in the form of a declaration of conformity” (expired). ConsultantPlus. Available at: https://www.consultant.ru/document/cons_doc_LAW_94853/?ysclid=m20d501m2y202631500 (accessed 09.23.2024) (in Russian).</mixed-citation></ref><ref id="B8"><label>8.</label><mixed-citation>Decision of the Customs Union Commission No. 620 dated April 7, 2011 “On a single list of products subject to mandatory conformity assessment with the issuance of certificates of conformity and declarations of conformity in a single form””. Garant. Available at: https://base.garant.ru/12185812/?ysclid=m20d8q659z998966044#friends (accessed 09.23.2024) (in Russian).</mixed-citation></ref><ref id="B9"><label>9.</label><mixed-citation>Decision of the EEC Council dated 08/19/2022 No. 119 “On Amendments to the Unified List of Products subject to mandatory conformity assessment with the issuance of certificates of conformity and declarations of conformity in a single form”. Alta Soft. Available at: https://www.alta.ru/tamdoc/22sr0119/?ysclid=m20dc57ik1520155906 (accessed 09.23.2024) (in Russian).</mixed-citation></ref><ref id="B10"><label>10.</label><mixed-citation>Register of registered medical devices. Nevasert Certification Center. Available at: https://nevacert.ru/reestry/med-reestr?ysclid=m20ge729fo588099472 (accessed 09.23.2024) (in Russian).</mixed-citation></ref><ref id="B11"><label>11.</label><mixed-citation>Federal Law No. 323-FZ dated 11.21.2011 “On the Basics of public Health protection in the Russian Federation”. ConsultantPlus. Available at: https://www.consultant.ru/document/cons_doc_LAW_121895/ddcfddbdbb49e64f085b65473218611b4bb6cd65/?ysclid=m20b8h8za0507454477 (accessed 09.23.2024) (in Russian).</mixed-citation></ref><ref id="B12"><label>12.</label><mixed-citation>Order of the Ministry of Health of the Russian Federation No. 661n dated June 30, 2020 “On Approval of the Procedure for the Import of medical devices into the Territory of the Russian Federation for the purpose of state registration”. Garant. Available at: https://www.garant.ru/products/ipo/prime/doc/74592262/?ysclid=m20htv65ke226040354 (accessed 09.23.2024) (in Russian).</mixed-citation></ref><ref id="B13"><label>13.</label><mixed-citation>Decree of the Government of the Russian Federation dated 03.18.2020 No. 299 “On Amendments to the Rules of State registration of medical devices”. Alta Soft. Available at: https://www.alta.ru/tamdoc/20ps0299/?ysclid=m20hyyml1e103596424 (accessed 09.23.2024) (in Russian).</mixed-citation></ref><ref id="B14"><label>14.</label><mixed-citation>Decree of the Government of the Russian Federation dated 07.04.2020 No. 982 “On invalidation of Certain Acts and Certain Provisions of Certain Acts of the Government of the Russian Federation and on the repeal of Certain Acts of federal executive authorities containing mandatory requirements, compliance with which is assessed during control measures in the implementation of state control over the circulation of medical devices”. Alta Soft. Available at: https://www.alta.ru/tamdoc/20ps0982/?ysclid=m20mozewi9877043435 (accessed 10.03.2024) (in Russian).</mixed-citation></ref><ref id="B15"><label>15.</label><mixed-citation>Decision of the EEC Board dated 04.21.2015 No. 30 “On non-tariff regulation measures”. Alta Soft. Available at: https://www.alta.ru/tamdoc/15kr0030/?ysclid=m20mrqipeu808550749 (accessed 10.03.2024) (in Russian).</mixed-citation></ref><ref id="B16"><label>16.</label><mixed-citation>Decree of the Government of the Russian Federation dated 05.02.2015 No. 102 “On restrictions and conditions for the admission of certain types of medical devices originating from foreign countries for the purposes of procurement for state and municipal needs”. [Alta Soft. Available at: https://www.alta.ru/tamdoc/15ps0102/?ysclid=m20mw08s15946824664 (accessed 10.03.2024) (in Russian).</mixed-citation></ref><ref id="B17"><label>17.</label><mixed-citation>Pogarskaya A. S. On the issue of parallel import of medical devices and their components to the Russian Federation in the context of sanctions policy. Problems of Social Hygiene, Health Care and the History of Medicine. 2024;32(12):43–51 (in Russian).</mixed-citation></ref><ref id="B18"><label>18.</label><mixed-citation>Pogarskaya A. S. Problematic aspects of customs regulation of imported medical device accessories. Problems of Social Hygiene, Health Care and the History of Medicine. 2023;31(S1):813–9 (in Russian).</mixed-citation></ref></ref-list></back></article>
