{"id":493,"date":"2022-11-22T09:59:04","date_gmt":"2022-11-22T17:59:04","guid":{"rendered":"https:\/\/silosa.ca\/?page_id=493"},"modified":"2026-05-01T00:02:14","modified_gmt":"2026-05-01T07:02:14","slug":"regulatory","status":"publish","type":"page","link":"https:\/\/silosa.ca\/index.php\/regulatory\/","title":{"rendered":"Regulatory"},"content":{"rendered":"

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US FDA Agent Services for foreign companies<\/h1>\n
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US Agent services for foreign companies at lowest fee. US Agent plays important role for regulatory communication.<\/p>\n<\/div>\n<\/div>\n

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Regulatory Submissions for Medical Devices<\/h1>\n

Determining what regulatory will be required for your medical device is to properly classify your medical device. Medical Devices in both the United States and Canada are classified based on risk, with regulatory oversight increasing with each class.<\/p>\n

Canada & USA, EU (Europe Union)<\/h3>\n

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US Agent appointment is a mandatory requirement for foreign companies to register with the FDA, serving as the official point of contact for communication between the FDA and the company. Our comprehensive FDA regulatory services support businesses across food, cosmetics, medical devices, pharmaceuticals, and other regulated industries. We provide reliable US Agent representation along with end-to-end assistance in facility registration, product listing, labeling compliance, and regulatory submissions. Our team helps ensure adherence to FDA requirements, facilitates smooth communication with the agency, and supports ongoing compliance to enable successful entry and continued presence in the U.S. market.<\/p>\n

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The Medical Devices Bureau of the Therapeutic Products Directorate (TPD) is the regulatory body responsible for licensing medical devices in Canada. Our specialized regulatory and compliance services support medical device manufacturers in navigating Health Canada requirements efficiently and accurately. We assist with device classification, preparation and submission of Medical Device Licence (MDL) and Medical Device Establishment Licence (MDEL) applications, technical file compilation, and quality management system compliance in line with Canadian regulations. Our team ensures a smooth approval process, helping you achieve timely market entry while maintaining full compliance with national standards and regulatory expectations.<\/p>\n

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New MDR Registration and transition consulting from MDD to MDR. Our CE marking services for the medical industry provide end-to-end support to ensure your products meet the stringent requirements of the European regulatory framework. We assist with conformity assessments, technical documentation preparation, clinical evaluation reports, risk management, and quality management system alignment in accordance with MDR standards. Our team works closely with manufacturers to streamline the certification process, minimize delays, and ensure successful market access across the EU while maintaining full compliance with applicable regulations.<\/p>\n

[\/et_pb_toggle][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section bb_built=”1″ admin_label=”Mission” _builder_version=”3.27″ background_color=”#22272a” background_image=”http:\/\/silosa.ca\/wp-content\/uploads\/2021\/09\/venture_03.png” _i=”2″ _address=”2″ prev_background_color=”#f5f7fa” next_background_color=”#ffffff”][et_pb_row column_structure=”2_5,3_5″ _builder_version=”3.26.4″ custom_margin=”30px|auto|30px|auto|true|” _i=”1″ _address=”2.1″][et_pb_column type=”2_5″ _builder_version=”3.26.7″ _i=”0″ _address=”2.1.0″][et_pb_text _builder_version=”3.26.7″ text_font=”Merriweather||||||||” text_text_align=”right” text_text_color=”#ffcf56″ text_font_size=”24px” text_line_height=”1.3em” border_color_all=”rgba(255,207,86,0.5)” border_width_bottom=”1px” transform_scale_last_edited=”on|desktop” transform_translate=”-130%|0px” transform_translate_phone=”0%|0px” transform_translate_last_edited=”on|desktop” transform_translate_linked=”off” transform_rotate_last_edited=”on|desktop” transform_skew_last_edited=”on|desktop” transform_origin_last_edited=”on|desktop” transform_styles_last_edited=”on|desktop” width=”50px” max_width=”800px” custom_margin=”||-38px||false|false” custom_margin_phone=”||12px||false|false” custom_margin_last_edited=”on|phone” animation_style=”slide” text_text_align_phone=”left” text_text_align_last_edited=”on|phone” locked=”off” _i=”0″ _address=”2.1.0.0″ text_orientation=”right”]<\/p>\n

02<\/p>\n

[\/et_pb_text][et_pb_text _builder_version=”4.10.7″ header_2_font=”Merriweather||||||||” header_2_font_size=”50px” header_2_line_height=”1.4em” background_layout=”dark” max_width=”800px” header_2_font_size_tablet=”36px” header_2_font_size_phone=”24px” header_2_font_size_last_edited=”on|desktop” locked=”off” _i=”1″ _address=”2.1.0.1″ text_text_shadow_horizontal_length=”text_text_shadow_style,%91object Object%93″ text_text_shadow_horizontal_length_tablet=”0px” text_text_shadow_vertical_length=”text_text_shadow_style,%91object Object%93″ text_text_shadow_vertical_length_tablet=”0px” text_text_shadow_blur_strength=”text_text_shadow_style,%91object Object%93″ text_text_shadow_blur_strength_tablet=”1px” link_text_shadow_horizontal_length=”link_text_shadow_style,%91object Object%93″ link_text_shadow_horizontal_length_tablet=”0px” link_text_shadow_vertical_length=”link_text_shadow_style,%91object Object%93″ link_text_shadow_vertical_length_tablet=”0px” link_text_shadow_blur_strength=”link_text_shadow_style,%91object Object%93″ link_text_shadow_blur_strength_tablet=”1px” ul_text_shadow_horizontal_length=”ul_text_shadow_style,%91object Object%93″ ul_text_shadow_horizontal_length_tablet=”0px” ul_text_shadow_vertical_length=”ul_text_shadow_style,%91object Object%93″ ul_text_shadow_vertical_length_tablet=”0px” ul_text_shadow_blur_strength=”ul_text_shadow_style,%91object Object%93″ ul_text_shadow_blur_strength_tablet=”1px” ol_text_shadow_horizontal_length=”ol_text_shadow_style,%91object Object%93″ ol_text_shadow_horizontal_length_tablet=”0px” ol_text_shadow_vertical_length=”ol_text_shadow_style,%91object Object%93″ ol_text_shadow_vertical_length_tablet=”0px” ol_text_shadow_blur_strength=”ol_text_shadow_style,%91object Object%93″ ol_text_shadow_blur_strength_tablet=”1px” quote_text_shadow_horizontal_length=”quote_text_shadow_style,%91object Object%93″ quote_text_shadow_horizontal_length_tablet=”0px” quote_text_shadow_vertical_length=”quote_text_shadow_style,%91object Object%93″ quote_text_shadow_vertical_length_tablet=”0px” quote_text_shadow_blur_strength=”quote_text_shadow_style,%91object Object%93″ quote_text_shadow_blur_strength_tablet=”1px” header_text_shadow_horizontal_length=”header_text_shadow_style,%91object Object%93″ header_text_shadow_horizontal_length_tablet=”0px” header_text_shadow_vertical_length=”header_text_shadow_style,%91object Object%93″ header_text_shadow_vertical_length_tablet=”0px” header_text_shadow_blur_strength=”header_text_shadow_style,%91object Object%93″ header_text_shadow_blur_strength_tablet=”1px” header_2_text_shadow_horizontal_length=”header_2_text_shadow_style,%91object Object%93″ header_2_text_shadow_horizontal_length_tablet=”0px” header_2_text_shadow_vertical_length=”header_2_text_shadow_style,%91object Object%93″ header_2_text_shadow_vertical_length_tablet=”0px” header_2_text_shadow_blur_strength=”header_2_text_shadow_style,%91object Object%93″ header_2_text_shadow_blur_strength_tablet=”1px” header_3_text_shadow_horizontal_length=”header_3_text_shadow_style,%91object Object%93″ header_3_text_shadow_horizontal_length_tablet=”0px” header_3_text_shadow_vertical_length=”header_3_text_shadow_style,%91object Object%93″ header_3_text_shadow_vertical_length_tablet=”0px” header_3_text_shadow_blur_strength=”header_3_text_shadow_style,%91object Object%93″ header_3_text_shadow_blur_strength_tablet=”1px” header_4_text_shadow_horizontal_length=”header_4_text_shadow_style,%91object Object%93″ header_4_text_shadow_horizontal_length_tablet=”0px” header_4_text_shadow_vertical_length=”header_4_text_shadow_style,%91object Object%93″ header_4_text_shadow_vertical_length_tablet=”0px” header_4_text_shadow_blur_strength=”header_4_text_shadow_style,%91object Object%93″ header_4_text_shadow_blur_strength_tablet=”1px” header_5_text_shadow_horizontal_length=”header_5_text_shadow_style,%91object Object%93″ header_5_text_shadow_horizontal_length_tablet=”0px” header_5_text_shadow_vertical_length=”header_5_text_shadow_style,%91object Object%93″ header_5_text_shadow_vertical_length_tablet=”0px” header_5_text_shadow_blur_strength=”header_5_text_shadow_style,%91object Object%93″ header_5_text_shadow_blur_strength_tablet=”1px” header_6_text_shadow_horizontal_length=”header_6_text_shadow_style,%91object Object%93″ header_6_text_shadow_horizontal_length_tablet=”0px” header_6_text_shadow_vertical_length=”header_6_text_shadow_style,%91object Object%93″ header_6_text_shadow_vertical_length_tablet=”0px” header_6_text_shadow_blur_strength=”header_6_text_shadow_style,%91object Object%93″ header_6_text_shadow_blur_strength_tablet=”1px” box_shadow_horizontal_tablet=”0px” box_shadow_vertical_tablet=”0px” box_shadow_blur_tablet=”40px” box_shadow_spread_tablet=”0px” vertical_offset_tablet=”0″ horizontal_offset_tablet=”0″ z_index_tablet=”0″]<\/p>\n

Our Vision<\/h2>\n

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Upgrading Implementation of\u00a0 (ISO) Management System Standards, Training programs empower young people with skills, knowledge and providing a great framework of standardization worldwide by implementing encouraging programs for recognizing National Industrial, agricultural products and services at Regional and International level.<\/p>\n

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\n03<\/p>\n

[\/et_pb_text][et_pb_text _builder_version=”3.26.4″ header_2_font=”Merriweather||||||||” header_2_font_size=”50px” header_2_line_height=”1.4em” background_layout=”dark” max_width=”800px” header_2_font_size_tablet=”36px” header_2_font_size_phone=”24px” header_2_font_size_last_edited=”on|desktop” locked=”off” _i=”1″ _address=”2.2.0.1″ text_orientation=”left”]<\/p>\n

Our Mission<\/h2>\n

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    \n
  • Publication high level international Training Books<\/li>\n
  • Implementing Train & Employment programs (TEP) worldwide<\/li>\n
  • Management Consultancy to the Government\u2019s projects<\/li>\n
  • Upgrading Quality and standardization<\/li>\n
  • Special Consideration to\u00a0Health<\/u><\/strong>,\u00a0Safety\u00a0<\/u><\/strong>and\u00a0Environment<\/u><\/strong><\/li>\n<\/ul>\n

    [\/et_pb_text][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section bb_built=”1″ admin_label=”Stats” custom_padding_last_edited=”on|desktop” _builder_version=”3.27″ custom_padding=”130px||130px||true|false” custom_padding_phone=”60px||60px||true|false” bottom_divider_style=”graph” bottom_divider_color=”rgba(0,0,0,0.04)” bottom_divider_height=”80%” _i=”5″ _address=”5″ prev_background_color=”#22272a” next_background_color=”#000000″][et_pb_row _builder_version=”3.26.4″ _i=”0″ _address=”5.0″][et_pb_column type=”4_4″ _builder_version=”3.26.4″ _i=”0″ _address=”5.0.0″][et_pb_text _builder_version=”4.10.7″ text_font=”Merriweather||||||||” text_text_align=”center” text_text_color=”#ffcf56″ text_font_size=”24px” text_line_height=”1.3em” border_color_all=”rgba(255,207,86,0.5)” border_width_bottom=”1px” background_layout=”dark” width=”100px” max_width=”800px” module_alignment=”center” locked=”off” _i=”0″ _address=”5.0.0.0″ text_orientation=”center”]<\/p>\n

    Stats<\/p>\n

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    SCG By the Numbers<\/h2>\n

    Silosa Consulting Group Inc. activities and experiences in more than 25 countries :<\/p>\n

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    Leave a Message<\/h3>\n

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header_5_text_shadow_blur_strength=”header_5_text_shadow_style,%91object Object%93″ header_5_text_shadow_blur_strength_tablet=”1px” header_6_text_shadow_horizontal_length=”header_6_text_shadow_style,%91object Object%93″ header_6_text_shadow_horizontal_length_tablet=”0px” header_6_text_shadow_vertical_length=”header_6_text_shadow_style,%91object Object%93″ header_6_text_shadow_vertical_length_tablet=”0px” header_6_text_shadow_blur_strength=”header_6_text_shadow_style,%91object Object%93″ header_6_text_shadow_blur_strength_tablet=”1px” box_shadow_horizontal_tablet=”0px” box_shadow_vertical_tablet=”0px” box_shadow_blur_tablet=”40px” box_shadow_spread_tablet=”0px” vertical_offset_tablet=”0″ horizontal_offset_tablet=”0″ z_index_tablet=”0″]<\/p>\n

    Got an Idea?<\/h3>\n

    Silosa Consulting Group Inc. offers outsourcing services for various Management System\u00a0 functions such as:<\/p>\n

    Supplier onboarding assessment,\u00a0<\/p>\n

    Product Certification Audits<\/p>\n

    Management System development and Continuous performance monitoring<\/p>\n

    SCG can perform\u00a0 Pre-assessment, Assessments of Audit, Internal Audits<\/p>\n

    SCG can execute continual improvement activities to assist organizations<\/p>\n

    [\/et_pb_text][et_pb_button button_text=”Submit a Project” button_alignment=”center” _builder_version=”3.27.1″ custom_button=”on” button_text_size=”14px” button_text_color=”#ffffff” button_bg_color=”#22272a” button_border_width=”0px” button_border_radius=”0px” button_letter_spacing=”1px” button_font=”|700||on|||||” custom_padding=”16px|28px|16px|28px|true|true” locked=”off” box_shadow_color__hover=”#2585b2″ box_shadow_blur__hover_enabled=”on” box_shadow_blur__hover=”40px” box_shadow_vertical__hover_enabled=”on” box_shadow_vertical__hover=”20px” _i=”1″ _address=”1.0.1.1″ button_bg_enable_color=”on” \/][\/et_pb_column][\/et_pb_row][et_pb_row column_structure=”1_4,1_4,1_4,1_4″ _builder_version=”3.26.4″ _i=”0″ _address=”8.0″][et_pb_column type=”1_4″ _builder_version=”3.26.4″ _i=”0″ _address=”8.0.0″][et_pb_text _builder_version=”4.10.7″ text_line_height=”2em” link_font=”||||on||||” link_text_color=”#3f3fff” header_4_font=”Merriweather||||||||” header_4_font_size=”16px” 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header_5_text_shadow_blur_strength=”header_5_text_shadow_style,%91object Object%93″ header_5_text_shadow_blur_strength_tablet=”1px” header_6_text_shadow_horizontal_length=”header_6_text_shadow_style,%91object Object%93″ header_6_text_shadow_horizontal_length_tablet=”0px” header_6_text_shadow_vertical_length=”header_6_text_shadow_style,%91object Object%93″ header_6_text_shadow_vertical_length_tablet=”0px” header_6_text_shadow_blur_strength=”header_6_text_shadow_style,%91object Object%93″ header_6_text_shadow_blur_strength_tablet=”1px” box_shadow_horizontal_tablet=”0px” box_shadow_vertical_tablet=”0px” box_shadow_blur_tablet=”40px” box_shadow_spread_tablet=”0px” vertical_offset_tablet=”0″ horizontal_offset_tablet=”0″ z_index_tablet=”0″]<\/p>\n

    Our Office<\/h4>\n

    Parkway Blvd.,
    Coquitlam, BC V3E3K5, CANADA<\/p>\n

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    Contact Us<\/h4>\n

    +1- 778 -751-8127
    info@silosa.ca<\/a>\u00a0<\/p>\n

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    Office Hours<\/h4>\n

    Mon-Fri: 9am – 5pm
    Sat-Sun: Closed<\/p>\n

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    US FDA Agent Services for foreign companies US Agent services for foreign companies at lowest fee. US Agent plays important role for regulatory communication. Regulatory Submissions for Medical Devices Determining what regulatory will be required for your medical device is to properly classify your medical device. 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