[et_pb_section fb_built=”1″ next_background_color=”#ffffff” _builder_version=”4.24.0″ _module_preset=”default” background_color=”rgba(46,58,71,0.64)” background_image=”https:\/\/ssmk-moscow.cn\/en\/wp-content\/uploads\/sites\/2\/2024\/02\/services-bg.webp” background_position=”top_center” background_blend=”overlay” background_enable_pattern_style=”on” background_pattern_style=”honeycomb” background_pattern_color=”rgba(0,0,0,0.04)” width=”100%” module_alignment=”center” custom_padding=”80px||80px||true|false” bottom_divider_style=”curve” bottom_divider_height=”50px” bottom_divider_height_tablet=”50px” bottom_divider_height_phone=”20px” bottom_divider_height_last_edited=”on|phone” global_colors_info=”{}”][et_pb_row _builder_version=”4.24.0″ _module_preset=”default” max_width=”100%” module_alignment=”center” global_colors_info=”{}”][et_pb_column type=”4_4″ _builder_version=”4.16″ _module_preset=”default” global_colors_info=”{}”][et_pb_divider divider_weight=”6px” _builder_version=”4.24.0″ _module_preset=”default” width=”132px” module_alignment=”center” locked=”off” global_colors_info=”{}”][\/et_pb_divider][et_pb_text _builder_version=”4.24.0″ _module_preset=”default” text_text_color=”#FFFFFF” text_font_size=”20px” text_line_height=”1.9em” header_font=”|700|||||||” header_text_align=”center” header_text_color=”#ffffff” header_line_height=”1.3em” text_orientation=”center” custom_margin=”-10px|||||” text_font_size_tablet=”” text_font_size_phone=”14px” text_font_size_last_edited=”on|phone” header_font_size_tablet=”” header_font_size_phone=”25px” header_font_size_last_edited=”on|phone” header_line_height_tablet=”” header_line_height_phone=”1.4em” header_line_height_last_edited=”on|phone” global_colors_info=”{}”]<\/p>\n
Obtaining a Medical Device Registration Certificate According to Russian Regulations<\/span><\/p>\n [\/et_pb_text][et_pb_divider divider_weight=”6px” _builder_version=”4.24.0″ _module_preset=”default” width=”132px” module_alignment=”center” locked=”off” global_colors_info=”{}”][\/et_pb_divider][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=”1″ _builder_version=”4.24.0″ _module_preset=”default” background_enable_color=”off” custom_padding=”80px||5px|||” global_colors_info=”{}”][et_pb_row column_structure=”1_4,3_4″ use_custom_gutter=”on” gutter_width=”2″ make_equal=”on” _builder_version=”4.24.0″ _module_preset=”default” max_width=”100%” custom_padding=”0px||0px|||” global_colors_info=”{}”][et_pb_column type=”1_4″ _builder_version=”4.24.0″ _module_preset=”default” background_color=”#d2a343″ link_option_url_new_window=”on” custom_css_main_element=”display: flex;||flex-direction: column;||justify-content: center;” border_radii=”off||||” border_color_all=”#e5e5e5″ box_shadow_style=”preset1″ box_shadow_vertical=”0px” box_shadow_blur=”0px” global_colors_info=”{}” box_shadow_vertical__hover_enabled=”on|hover” box_shadow_vertical__hover=”2px” box_shadow_blur__hover_enabled=”on|hover” box_shadow_blur__hover=”18px”][et_pb_text _builder_version=”4.24.0″ _module_preset=”default” text_text_color=”#FFFFFF” header_font=”|||on|||||” header_text_color=”#FFFFFF” header_font_size=”40px” header_2_text_color=”#FFFFFF” custom_padding=”|30px||30px|false|true” custom_padding_tablet=”40px|30px|40px|30px|true|true” custom_padding_phone=”44px||44px||true|true” custom_padding_last_edited=”on|phone” global_colors_info=”{}”]<\/p>\n [\/et_pb_text][\/et_pb_column][et_pb_column type=”3_4″ _builder_version=”4.24.0″ _module_preset=”default” link_option_url_new_window=”on” border_color_all=”#e5e5e5″ global_colors_info=”{}” box_shadow_vertical__hover=”2px” box_shadow_vertical__hover_enabled=”on|hover” box_shadow_blur__hover=”18px” box_shadow_blur__hover_enabled=”on|hover”][et_pb_text _builder_version=”4.24.0″ _module_preset=”default” global_colors_info=”{}”]<\/p>\n In accordance with paragraph 4 of Article 38 of the Federal Law “On the Basics of Health Protection of Citizens in the Russian Federation” dated November 21, 2011, N 323-FZ, the circulation of medical devices registered in the manner established by the Government of the Russian Federation and its authorized federal executive body is permitted in the Russian Federation.<\/p>\n The registration of medical devices (MD) is a state procedure designed to ensure that only high-quality, effective, and safe devices are available on the market. The registration certificate (RC) is a document that confirms the MD\u2019s compliance with established requirements and the fact of their registration in Russia. The RC is a necessary document for the circulation of MDs in the market. In other words, MD registration is a mandatory condition for their import, use, sale, and also production within the territory of the Russian Federation.<\/p>\n The Federal Service for Surveillance in Healthcare of the Russian Federation (Roszdravnadzor) carries out the registration of MDs in the Russian Federation. During the state registration service process, Roszdravnadzor sends the MD registration dossier for expert assessment of quality, safety, and effectiveness to one of its subordinate organizations.<\/p>\n LLC “SSMK” prepares the registration dossier (RD) in accordance with legislative requirements and registration rules.<\/p>\n Currently, a medical device can also be registered for circulation within the Russian Federation according to:<\/p>\n The process of preparing the registration dossier (a set of documents necessary for the registration of a medical device) for a medical device involves comprehensive documentation and adherence to current regulations and standards.<\/p>\n [\/et_pb_text][\/et_pb_column][\/et_pb_row][et_pb_row _builder_version=”4.24.0″ _module_preset=”default” custom_padding=”||0px|||” global_colors_info=”{}”][et_pb_column type=”4_4″ _builder_version=”4.24.0″ _module_preset=”default” global_colors_info=”{}”][et_pb_text _builder_version=”4.24.0″ _module_preset=”default” header_3_text_align=”center” header_3_font_size=”30px” header_3_line_height=”1.3em” global_colors_info=”{}” custom_margin=”||29px|||”]<\/p>\n [\/et_pb_text][et_pb_image src=”https:\/\/ssmk-moscow.cn\/en\/wp-content\/uploads\/sites\/2\/2024\/02\/stage1_1.jpg” title_text=”stage1_1″ show_in_lightbox=”on” use_overlay=”on” align=”center” _builder_version=”4.24.0″ _module_preset=”default” hover_enabled=”0″ global_colors_info=”{}” sticky_enabled=”0″][\/et_pb_image][et_pb_text _builder_version=”4.24.0″ _module_preset=”default” header_3_text_align=”center” header_3_font_size=”30px” header_3_line_height=”1.3em” global_colors_info=”{}”]<\/p>\n [\/et_pb_text][et_pb_image src=”https:\/\/ssmk-moscow.cn\/en\/wp-content\/uploads\/sites\/2\/2024\/02\/stage-2.jpg” title_text=”stage-2″ show_in_lightbox=”on” use_overlay=”on” align=”center” _builder_version=”4.24.0″ _module_preset=”default” global_colors_info=”{}”][\/et_pb_image][et_pb_text _builder_version=”4.24.0″ _module_preset=”default” text_text_color=”#000000″ header_3_text_align=”center” header_3_font_size=”30px” header_3_line_height=”1.3em” global_colors_info=”{}”]<\/p>\n <\/p>\n The duration for preparing a registration dossier depends on the risk class of the medical device (MD), the chosen registration scheme for the MD, the required volume of testing, and the extent of documentation that needs to be prepared. We register devices within very tight deadlines, as we conduct certain stages of the procedure in parallel where possible, saving your time. The expedited preparation of the registration dossier can take as little as 1.5 months with prompt provision of all required documentation, information, and samples. The average time for preparing the registration dossier is 3-4 months.<\/p>\n The review period for the registration dossier by the ROSZDRAVNADZOR:<\/strong><\/p>\n [\/et_pb_text][et_pb_image src=”https:\/\/ssmk-moscow.cn\/en\/wp-content\/uploads\/sites\/2\/2024\/02\/stage3.jpg” title_text=”stage3″ show_in_lightbox=”on” use_overlay=”on” align=”center” _builder_version=”4.24.0″ _module_preset=”default” global_colors_info=”{}”][\/et_pb_image][et_pb_image src=”https:\/\/ssmk-moscow.cn\/en\/wp-content\/uploads\/sites\/2\/2024\/02\/stage4.jpg” title_text=”stage4″ show_in_lightbox=”on” use_overlay=”on” align=”center” _builder_version=”4.24.0″ _module_preset=”default” global_colors_info=”{}”][\/et_pb_image][et_pb_text _builder_version=”4.24.0″ _module_preset=”default” text_text_color=”#000000″ header_3_text_align=”center” header_3_font_size=”30px” header_3_line_height=”1.3em” hover_enabled=”0″ global_colors_info=”{}” sticky_enabled=”0″]<\/p>\n To assemble a registration dossier (a set of documents required for the registration of a medical device), the following documents are needed:<\/em><\/p>\n For domestically produced devices:<\/strong><\/p>\n For foreign-manufactured devices:<\/strong><\/p>\n Depending on the complexity of the medical device, its risk class, and functional characteristics, the list of required documents may change.<\/p>\n Upon a positive outcome, the federal service issues a registration certificate and its annex.<\/p>\n We provide management and professional assistance at all stages of the project, including dossier preparation, addressing remarks, and preparing substantiated responses to expert services inquiries.<\/p>\n Please send us your inquiry. Our registration specialists will analyze your data, select an optimal registration algorithm, evaluate the volume of work required for dossier preparation, and send you a commercial offer for these services.<\/strong><\/p>\n<\/blockquote>\n [\/et_pb_text][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=”1″ module_id=”form” _builder_version=”4.24.0″ _module_preset=”default” background_enable_color=”off” custom_padding=”80px||80px||true|” global_module=”283″ saved_tabs=”all” locked=”off” global_colors_info=”{}”][et_pb_row use_custom_gutter=”on” make_equal=”on” _builder_version=”4.24.0″ _module_preset=”default” custom_padding=”0px||0px|||” global_colors_info=”{}”][et_pb_column type=”4_4″ _builder_version=”4.16″ _module_preset=”default” global_colors_info=”{}”][et_pb_divider divider_weight=”6px” _builder_version=”4.24.0″ _module_preset=”default” width=”132px” module_alignment=”center” global_colors_info=”{}”][\/et_pb_divider][et_pb_text _builder_version=”4.24.0″ 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button_two_letter_spacing__hover_enabled=”off” button_bg_color__hover_enabled=”off” button_one_bg_color__hover_enabled=”off” button_two_bg_color__hover_enabled=”off”][\/et_pb_contact_field][et_pb_contact_field field_id=”Field_8″ field_type=”checkbox” checkbox_options=”%91{%22value%22:%22I agree with privacy policy %22,%22checked%22:0,%22dragID%22:-1}%93″ field_title_tablet=”” field_title_phone=”” field_title_last_edited=”on|desktop” _builder_version=”4.24.0″ _module_preset=”default” form_field_text_color=”#000000″ form_field_focus_text_color=”#FFFFFF” global_colors_info=”{}”][\/et_pb_contact_field][\/et_pb_contact_form][\/et_pb_column][\/et_pb_row][\/et_pb_section]<\/p>\n","protected":false},"excerpt":{"rendered":" Medical Device Registration in Russia Obtaining a Medical Device Registration Certificate According to Russian RegulationsWhat is registration and why is it necessary to obtain a registration certificate for medical devices?In accordance with paragraph 4 of Article 38 of the Federal Law “On the Basics of Health Protection of Citizens in the Russian Federation” dated November […]<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_et_pb_use_builder":"on","_et_pb_old_content":"","_et_gb_content_width":"","footnotes":""},"_links":{"self":[{"href":"https:\/\/ssmk-moscow.cn\/en\/wp-json\/wp\/v2\/pages\/290"}],"collection":[{"href":"https:\/\/ssmk-moscow.cn\/en\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/ssmk-moscow.cn\/en\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/ssmk-moscow.cn\/en\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/ssmk-moscow.cn\/en\/wp-json\/wp\/v2\/comments?post=290"}],"version-history":[{"count":16,"href":"https:\/\/ssmk-moscow.cn\/en\/wp-json\/wp\/v2\/pages\/290\/revisions"}],"predecessor-version":[{"id":515,"href":"https:\/\/ssmk-moscow.cn\/en\/wp-json\/wp\/v2\/pages\/290\/revisions\/515"}],"wp:attachment":[{"href":"https:\/\/ssmk-moscow.cn\/en\/wp-json\/wp\/v2\/media?parent=290"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}What is registration and why is it necessary to obtain a registration certificate for medical devices?<\/span><\/h2>\n
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First Stage of Dossier Preparation<\/span><\/h3>\n
Second Stage of Dossier Preparation<\/span><\/h3>\n
The timeframe for obtaining registration certificates for medical devices<\/h3>\n
Documents for Medical Device Registration<\/h3>\n
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Consultation Request: <\/span><\/h4>\n