[et_pb_section fb_built=”1″ next_background_color=”#ffffff” _builder_version=”4.24.0″ _module_preset=”default” background_color=”#fcfcfc” background_enable_image=”off” background_position=”top_center” background_blend=”overlay” background_enable_video_mp4=”off” width=”100%” module_alignment=”center” min_height=”1px” custom_margin=”0px||0px||false|false” custom_padding=”0px||0px||false|false” bottom_divider_style=”curve” bottom_divider_height=”0px” bottom_divider_repeat=”1x” bottom_divider_arrangement=”above_content” bottom_divider_style_tablet=”curve” bottom_divider_style_phone=”curve” bottom_divider_style_last_edited=”on|desktop” bottom_divider_color_tablet=”#FFFFFF” bottom_divider_color_phone=”#FFFFFF” bottom_divider_color_last_edited=”on|desktop” bottom_divider_height_tablet=”50px” bottom_divider_height_phone=”50px” bottom_divider_height_last_edited=”on|desktop” bottom_divider_arrangement_tablet=”above_content” bottom_divider_arrangement_phone=”above_content” bottom_divider_arrangement_last_edited=”on|tablet” global_colors_info=”{}”][et_pb_row use_custom_gutter=”on” gutter_width=”1″ make_equal=”on” custom_padding_last_edited=”on|phone” _builder_version=”4.24.0″ _module_preset=”default” background_color=”#919191″ background_image=”https:\/\/mos-mtk.cn\/en\/wp-content\/uploads\/sites\/2\/2024\/01\/regmed7.webp” background_size=”contain” background_position=”center_right” background_enable_video_mp4=”off” background_video_width=”50%” background_enable_mask_style=”on” background_mask_style=”chevrons” background_mask_color=”#f9f9f9″ background_mask_transform=”flip_vertical” width=”100%” max_width=”100%” height_tablet=”auto” height_phone=”auto” height_last_edited=”on|phone” custom_padding=”6%||6%||true|false” custom_padding_tablet=”70px||70px||true|false” custom_padding_phone=”70px||70px||true|false” background_color_tablet=”#394c4c” background_last_edited=”on|phone” background_enable_color_tablet=”on” background_enable_color_phone=”off” background_image_tablet=”https:\/\/mos-mtk.cn\/en\/wp-content\/uploads\/sites\/2\/2024\/01\/regmed7.webp” background_enable_image_tablet=”on” background_enable_image_phone=”off” parallax_tablet=”off” background_size_tablet=”cover” background_size_phone=”cover” background_image_width_phone=”100%” background_image_height_phone=”100%” background_blend_tablet=”overlay” background_enable_pattern_style_tablet=”off” background_enable_pattern_style_phone=”on” background_pattern_style_phone=”honeycomb” background_pattern_color_phone=”rgba(191,191,191,0.11)” background_enable_mask_style_tablet=”off” global_colors_info=”{}”][et_pb_column type=”4_4″ disabled_on=”off|off|off” _builder_version=”4.24.0″ _module_preset=”default” background_enable_color=”off” transform_translate_linked=”off” z_index=”500″ custom_padding=”|2%||7%|true|false” custom_css_main_element=”margin:auto;” global_colors_info=”{}”][et_pb_text _builder_version=”4.24.0″ _module_preset=”default” text_text_color=”#000000″ header_font=”|800|||||||” header_text_color=”#000000″ header_font_size=”40px” header_line_height=”1.3em” header_2_font=”|800|||||||” header_2_text_color=”#1b1b1b” header_2_font_size=”55px” header_2_line_height=”1.2em” background_enable_color=”off” transform_translate_linked=”off” z_index=”500″ width=”50%” width_tablet=”99%” width_phone=”98%” width_last_edited=”on|phone” custom_margin=”10px||10px||false|false” custom_margin_tablet=”-0.4%||||false|false” custom_margin_phone=”10%||30px||false|false” custom_margin_last_edited=”on|phone” custom_padding=”||||false|true” text_text_color_tablet=”#FFFFFF” text_text_color_phone=”#000000″ text_text_color_last_edited=”on|phone” header_text_color_tablet=”#FFFFFF” header_text_color_phone=”#000000″ header_text_color_last_edited=”on|tablet” header_font_size_tablet=”” header_font_size_phone=”25px” header_font_size_last_edited=”on|phone” header_2_font_size_tablet=”55px” header_2_font_size_phone=”35px” header_2_font_size_last_edited=”on|phone” global_colors_info=”{}”]<\/p>\n
Conformity assessment, development and writing of a technical and operational documentation, verification and correction of documents prepared by the Manufacturer<\/p>\n
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[\/et_pb_text][\/et_pb_column][et_pb_column type=”3_5″ _builder_version=”4.24.0″ _module_preset=”default” custom_css_main_element=”margin:auto” global_colors_info=”{}”][et_pb_text ul_type=”square” _builder_version=”4.24.0″ _module_preset=”default” text_text_color=”#1b1b1b” text_line_height=”1.6em” header_2_font_size=”25px” header_2_line_height=”1.4em” header_3_font=”|800|||||||” header_3_font_size=”35px” header_3_line_height=”1.3em” header_4_font_size=”25px” header_4_line_height=”1.4em” text_orientation=”justified” custom_margin=”||0px|||” custom_margin_tablet=”” custom_margin_phone=”2px||||false|false” custom_margin_last_edited=”on|phone” header_3_font_size_tablet=”55px” header_3_font_size_phone=”35px” header_3_font_size_last_edited=”on|phone” header_3_line_height_tablet=”1.7em” header_3_line_height_phone=”1.2em” header_3_line_height_last_edited=”on|phone” global_colors_info=”{}”]<\/p>\n
As per Section 4 of the Rules for the State Registration of Medical Devices (Registration Rules) established by the Russian Federation Government Resolution No. 1416 of December 27, 2012:<\/p>\n
<\/p>\n
[\/et_pb_text][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=”1″ next_background_color=”#ecf0f1″ _builder_version=”4.24.0″ _module_preset=”default” background_color=”#f9f9f9″ custom_padding=”80px||80px|||” bottom_divider_style=”curve” bottom_divider_height=”40px” locked=”off” global_colors_info=”{}”][et_pb_row column_structure=”2_5,3_5″ use_custom_gutter=”on” make_equal=”on” _builder_version=”4.24.0″ _module_preset=”default” width=”90%” max_width=”100%” custom_padding=”||0px|||” global_colors_info=”{}”][et_pb_column type=”2_5″ _builder_version=”4.24.0″ _module_preset=”default” custom_css_main_element=”margin:auto” global_colors_info=”{}”][et_pb_text _builder_version=”4.24.0″ _module_preset=”default” text_text_color=”#1b1b1b” text_line_height=”1.6em” header_2_text_align=”left” header_2_text_color=”#FFFFFF” header_2_font_size=”35px” header_2_line_height=”1.4em” header_3_font=”|800|||||||” header_3_text_align=”left” header_3_text_color=”#FFFFFF” header_3_font_size=”35px” header_3_line_height=”1.3em” header_4_font_size=”25px” header_4_line_height=”1.4em” background_color=”#5da172″ background_enable_pattern_style=”on” background_pattern_style=”honeycomb” background_pattern_color=”rgba(0,0,0,0.07)” text_orientation=”justified” custom_margin=”||0px|||” custom_margin_tablet=”||35px||false|false” custom_margin_phone=”2px||||false|false” custom_margin_last_edited=”on|phone” custom_padding=”10%|35px|10%|35px|true|true” header_3_font_size_tablet=”35px” header_3_font_size_phone=”35px” header_3_font_size_last_edited=”on|phone” header_3_line_height_tablet=”1.3em” header_3_line_height_phone=”1.3em” header_3_line_height_last_edited=”on|phone” box_shadow_style=”preset2″ global_colors_info=”{}”]<\/p>\n
[\/et_pb_text][\/et_pb_column][et_pb_column type=”3_5″ _builder_version=”4.24.0″ _module_preset=”default” custom_css_main_element=”margin:auto” global_colors_info=”{}”][et_pb_text ul_type=”square” _builder_version=”4.24.1″ _module_preset=”default” text_text_color=”#1b1b1b” text_line_height=”1.6em” header_3_font=”|800|||||||” header_3_font_size=”25px” header_3_line_height=”1.3em” header_4_font_size=”25px” header_4_line_height=”1.4em” custom_margin=”||7px|||” custom_margin_tablet=”” custom_margin_phone=”2px||||false|false” custom_margin_last_edited=”on|phone” hover_enabled=”0″ header_3_font_size_tablet=”55px” header_3_font_size_phone=”35px” header_3_font_size_last_edited=”on|phone” header_3_line_height_tablet=”1.7em” header_3_line_height_phone=”1.2em” header_3_line_height_last_edited=”on|phone” global_colors_info=”{}” sticky_enabled=”0″]<\/p>\n
Technical requirements in the documentation for registered medical devices typically include:<\/strong><\/p>\n Composition and structure requirements (chemical, fractional, impurity concentration, component content, etc.), physical, chemical, mechanical, and other properties (strength, hardness, heat resistance, wear resistance, etc.).<\/p>\n<\/li>\n <\/span><\/p>\n [\/et_pb_text][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=”1″ _builder_version=”4.24.0″ _module_preset=”default” background_color=”#ecf0f1″ custom_padding=”80px||80px|||” bottom_divider_height=”50px” global_colors_info=”{}”][et_pb_row column_structure=”2_5,3_5″ use_custom_gutter=”on” make_equal=”on” _builder_version=”4.24.0″ _module_preset=”default” width=”90%” max_width=”100%” custom_padding=”||0px|||” global_colors_info=”{}”][et_pb_column type=”2_5″ _builder_version=”4.24.0″ _module_preset=”default” custom_css_main_element=”margin:auto” global_colors_info=”{}”][et_pb_text _builder_version=”4.24.0″ _module_preset=”default” text_text_color=”#1b1b1b” text_line_height=”1.6em” header_2_text_align=”left” header_2_text_color=”#FFFFFF” header_2_font_size=”35px” header_2_line_height=”1.4em” header_3_font=”|800|||||||” header_3_text_align=”left” header_3_text_color=”#FFFFFF” header_3_font_size=”35px” header_3_line_height=”1.3em” header_4_font_size=”25px” header_4_line_height=”1.4em” background_color=”#577371″ background_enable_pattern_style=”on” background_pattern_style=”honeycomb” background_pattern_color=”rgba(0,0,0,0.07)” text_orientation=”justified” custom_margin=”||0px|||” custom_margin_tablet=”||35px||false|false” custom_margin_phone=”2px||||false|false” custom_margin_last_edited=”on|tablet” custom_padding=”10%|35px|10%|35px|true|true” header_3_font_size_tablet=”35px” header_3_font_size_phone=”35px” header_3_font_size_last_edited=”on|phone” header_3_line_height_tablet=”1.3em” header_3_line_height_phone=”1.3em” header_3_line_height_last_edited=”on|phone” box_shadow_style=”preset2″ global_colors_info=”{}”]<\/p>\n [\/et_pb_text][\/et_pb_column][et_pb_column type=”3_5″ _builder_version=”4.24.0″ _module_preset=”default” custom_css_main_element=”margin:auto” global_colors_info=”{}”][et_pb_text _builder_version=”4.24.0″ _module_preset=”default” text_text_color=”#1b1b1b” text_line_height=”1.6em” header_2_font_size=”25px” header_2_line_height=”1.4em” header_3_font=”|800|||||||” header_3_font_size=”25px” header_3_line_height=”1.3em” header_4_font_size=”25px” header_4_line_height=”1.4em” text_orientation=”justified” custom_margin=”||0px|||” custom_margin_tablet=”” custom_margin_phone=”2px||||false|false” custom_margin_last_edited=”on|phone” header_3_font_size_tablet=”55px” header_3_font_size_phone=”35px” header_3_font_size_last_edited=”on|phone” header_3_line_height_tablet=”1.7em” header_3_line_height_phone=”1.2em” header_3_line_height_last_edited=”on|phone” global_colors_info=”{}”]<\/p>\n Technical documentation is a mandatory part of the registration dossier (Section 10 of the Registration Rules) and, alongside operational documentation, is a key component of the registration documents set.<\/p>\n Documents must align with the Ministry of Health of the Russian Federation Order dated January 19, 2017, N 11n \u201cOn approval of the requirements for the content of technical and operational documentation of a medical device\u201d.<\/p>\n Developing technical documentation for a medical device is a pivotal step in the state registration procedure. It defines the characteristics that ensure the device’s quality, safety, and efficacy.<\/p>\n Accredited laboratories must confirm the device’s compliance with technical documentation during testing and assess the operational documentation’s adherence to technical requirements. Following dossier submission, Roszdravnadzor will verify the technical documentation’s compliance with applicable standards and regulatory documents.<\/p>\n Therefore, technical documentation is foundational to the registration process. Its development requires the involvement of highly skilled professionals with broad competencies and relevant experience, making it one of the most sought-after and current services.<\/p>\n [\/et_pb_text][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=”1″ _builder_version=”4.24.1″ _module_preset=”default” background_color=”#f9f9f9″ custom_padding=”80px||80px|||” bottom_divider_height=”40px” hover_enabled=”0″ locked=”off” global_colors_info=”{}” sticky_enabled=”0″][et_pb_row column_structure=”2_5,3_5″ use_custom_gutter=”on” make_equal=”on” _builder_version=”4.24.0″ _module_preset=”default” width=”90%” max_width=”100%” custom_padding=”||0px|||” global_colors_info=”{}”][et_pb_column type=”2_5″ _builder_version=”4.24.0″ _module_preset=”default” custom_css_main_element=”margin:auto” global_colors_info=”{}”][et_pb_text _builder_version=”4.24.1″ _module_preset=”default” text_text_color=”#1b1b1b” text_line_height=”1.6em” header_2_text_align=”left” 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[\/et_pb_text][\/et_pb_column][et_pb_column type=”3_5″ _builder_version=”4.24.0″ _module_preset=”default” custom_css_main_element=”margin:auto” global_colors_info=”{}”][et_pb_text ul_type=”square” _builder_version=”4.24.1″ _module_preset=”default” text_text_color=”#1b1b1b” text_line_height=”1.6em” header_3_font=”|800|||||||” header_3_font_size=”25px” header_3_line_height=”1.3em” header_4_font_size=”25px” header_4_line_height=”1.4em” custom_margin=”||7px|||” custom_margin_tablet=”” custom_margin_phone=”2px||||false|false” custom_margin_last_edited=”on|phone” hover_enabled=”0″ header_3_font_size_tablet=”55px” header_3_font_size_phone=”35px” header_3_font_size_last_edited=”on|phone” header_3_line_height_tablet=”1.7em” header_3_line_height_phone=”1.2em” header_3_line_height_last_edited=”on|phone” global_colors_info=”{}” sticky_enabled=”0″ ol_line_height=”1.8em” ol_font_size=”20px” ol_font=”|700|||||||”]<\/p>\n * Documents must be prepared in accordance with Order of the Ministry of Health of the Russian Federation dated January 19, 2017 N 11n \u201cOn approval of the requirements for the content of technical and operational documentation of the manufacturer of a medical device\u201d.<\/em><\/p>\n [\/et_pb_text][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=”1″ _builder_version=”4.24.0″ _module_preset=”default” background_color=”#ecf0f1″ custom_padding=”80px||80px|||” bottom_divider_height=”50px” global_colors_info=”{}” locked=”off”][et_pb_row column_structure=”2_5,3_5″ use_custom_gutter=”on” make_equal=”on” _builder_version=”4.24.0″ _module_preset=”default” width=”90%” max_width=”100%” custom_padding=”||0px|||” global_colors_info=”{}”][et_pb_column type=”2_5″ _builder_version=”4.24.0″ _module_preset=”default” custom_css_main_element=”margin:auto” global_colors_info=”{}”][et_pb_text _builder_version=”4.24.1″ _module_preset=”default” text_text_color=”#1b1b1b” text_line_height=”1.6em” header_2_text_align=”left” header_2_text_color=”#FFFFFF” 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documentation, verification and correction of documents prepared by the ManufacturerOverview of Manufacturer’s Technical and Operational Documentation Requirements As per Section 4 of the Rules for the State Registration of Medical Devices (Registration Rules) established by the Russian Federation Government Resolution 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The Importance of Properly Prepared Technical Documentation<\/h3>\n
Technical Documents From The Manufacturer<\/h3>\n
\n
To develop the above documents listed below, the following documents will be required:<\/h3>\n
Technical Documentation (for foreign manufacturer) or Technical Conditions (for Russian manufacturer)<\/h3>\n
\n
<\/h3>\n
<\/h3>\n
Operational documentation<\/h3>\n
\n
To develop the above documents listed below, the following documents will be required:<\/h3>\n
Medical device validation and verification reports or Qualification tests\u00a0Act<\/h3>\n
\n
Risk management report<\/h3>\n
\n
Usability engineering file<\/h3>\n
\n
Software validation and verification report<\/h3>\n
\n
<\/ul>\n
Operational Documentation Development\u00a0<\/h3>\n
Request a Consultation for Medical Device Certification and Registration<\/span><\/h4>\n