{"id":9625,"date":"2024-05-30T10:35:01","date_gmt":"2024-05-30T02:35:01","guid":{"rendered":"https:\/\/greenoo.tw\/?page_id=9625"},"modified":"2024-06-14T21:00:47","modified_gmt":"2024-06-14T13:00:47","slug":"%e6%b5%b7%e5%a4%96%e5%b7%a5%e5%95%86","status":"publish","type":"page","link":"https:\/\/greenoo.tw\/en\/%e6%b5%b7%e5%a4%96%e5%b7%a5%e5%95%86\/","title":{"rendered":"Overseas Business"},"content":{"rendered":"<div data-elementor-type=\"wp-page\" data-elementor-id=\"9625\" class=\"elementor elementor-9625\" data-elementor-post-type=\"page\">\n\t\t\t\t<div class=\"elementor-element elementor-element-4800376 e-flex e-con-boxed e-con e-parent\" data-id=\"4800376\" data-element_type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-9c64b5d elementor-widget elementor-widget-image\" data-id=\"9c64b5d\" data-element_type=\"widget\" data-widget_type=\"image.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<style>\/*! elementor - v3.21.0 - 18-04-2024 *\/\n.elementor-widget-image{text-align:center}.elementor-widget-image a{display:inline-block}.elementor-widget-image a img[src$=\".svg\"]{width:48px}.elementor-widget-image img{vertical-align:middle;display:inline-block}<\/style>\t\t\t\t\t\t\t\t\t\t<img fetchpriority=\"high\" decoding=\"async\" width=\"2560\" height=\"939\" src=\"https:\/\/greenoo.tw\/wp-content\/uploads\/2024\/05\/FDA\u64d4\u4fdd-scaled.jpg\" class=\"attachment-large size-large wp-image-4262\" alt=\"\" srcset=\"https:\/\/greenoo.tw\/wp-content\/uploads\/2024\/05\/FDA\u64d4\u4fdd-scaled.jpg 2560w, https:\/\/greenoo.tw\/wp-content\/uploads\/2024\/05\/FDA\u64d4\u4fdd-768x282.jpg 768w, https:\/\/greenoo.tw\/wp-content\/uploads\/2024\/05\/FDA\u64d4\u4fdd-1536x563.jpg 1536w, https:\/\/greenoo.tw\/wp-content\/uploads\/2024\/05\/FDA\u64d4\u4fdd-2048x751.jpg 2048w\" sizes=\"(max-width: 2560px) 100vw, 2560px\" \/>\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-00ac7c6 e-flex e-con-boxed e-con e-parent\" data-id=\"00ac7c6\" data-element_type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-ddc9e0d elementor-widget elementor-widget-text-editor\" data-id=\"ddc9e0d\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<style>\/*! elementor - v3.21.0 - 18-04-2024 *\/\n.elementor-widget-text-editor.elementor-drop-cap-view-stacked .elementor-drop-cap{background-color:#69727d;color:#fff}.elementor-widget-text-editor.elementor-drop-cap-view-framed .elementor-drop-cap{color:#69727d;border:3px solid;background-color:transparent}.elementor-widget-text-editor:not(.elementor-drop-cap-view-default) .elementor-drop-cap{margin-top:8px}.elementor-widget-text-editor:not(.elementor-drop-cap-view-default) .elementor-drop-cap-letter{width:1em;height:1em}.elementor-widget-text-editor .elementor-drop-cap{float:left;text-align:center;line-height:1;font-size:50px}.elementor-widget-text-editor .elementor-drop-cap-letter{display:inline-block}<\/style>\t\t\t\t<p>The U.S. Food and Drug Administration (FDA) is a law enforcement agency of the U.S. federal government and is part of the U.S. Department of Health and Human Services (HHS), whose primary responsibility is to protect and promote public health by regulating and overseeing food and drug products. By regulating and supervising food, drugs, medical devices, cosmetics, animal drugs and tobacco products, FDA filing is not only a legal requirement, but also an important measure to protect product safety, enhance market competitiveness, strengthen brand reputation, facilitate cross-border trade and promote business improvement. Through FDA filing, enterprises can legally enter the U.S. market and gain the trust of consumers and the market, thus realizing sustainable development and long-term benefits.<\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-160aed8 e-grid e-con-boxed e-con e-parent\" data-id=\"160aed8\" data-element_type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-bf62aa2 elementor-widget elementor-widget-image\" data-id=\"bf62aa2\" data-element_type=\"widget\" data-widget_type=\"image.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t<img decoding=\"async\" width=\"1996\" height=\"1192\" src=\"https:\/\/greenoo.tw\/wp-content\/uploads\/2024\/06\/\u7f8e\u570b\u96f6\u98df.jpeg\" class=\"attachment-large size-large wp-image-9727\" alt=\"\" srcset=\"https:\/\/greenoo.tw\/wp-content\/uploads\/2024\/06\/\u7f8e\u570b\u96f6\u98df.jpeg 1996w, https:\/\/greenoo.tw\/wp-content\/uploads\/2024\/06\/\u7f8e\u570b\u96f6\u98df-768x459.jpeg 768w, https:\/\/greenoo.tw\/wp-content\/uploads\/2024\/06\/\u7f8e\u570b\u96f6\u98df-1536x917.jpeg 1536w\" sizes=\"(max-width: 1996px) 100vw, 1996px\" \/>\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-152f5f7 elementor-widget elementor-widget-text-editor\" data-id=\"152f5f7\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<h2><strong>FDA Food Category<\/strong><\/h2><p>Under the Food Safety Modernization Act (FSMA), all companies exporting food to the United States must register with the FDA. This is an important legal measure to ensure the safety of imported food. Food products that are not registered with the FDA may be refused importation, and registration is one of the necessary requirements for products to enter the U.S. market.<\/p><p>Compliance: Any business or individual involved in the production, processing, packaging, importing, wholesaling, retailing, and food service of food products in the United States is required to comply with the FDA's food compliance requirements.<\/p><p>Documents required for filing: Application form, Dun &amp; Bradstreet number, U.S. authorized agent.<\/p><p>Common products are processed foods, beverages, baked goods, dairy products, processed meats (e.g. sausages, bacon), frozen meats, ready-to-eat meat products, etc., fish, shellfish, and processed seafood products (e.g. canned tuna, frozen shrimp). All types of fresh fruits and vegetables, including organic and non-organic products, dried fruits and nuts, all kinds of cooking seasonings, spices, sugar, salt, oil, etc., preservatives, colorants, flavor enhancers, stabilizers, etc., dietary supplements, all kinds of pet food and snacks, which also need to comply with FDA regulations.<\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-bb4a901 e-grid e-con-boxed e-con e-parent\" data-id=\"bb4a901\" data-element_type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-f8768af elementor-widget elementor-widget-image\" data-id=\"f8768af\" data-element_type=\"widget\" data-widget_type=\"image.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t<img decoding=\"async\" width=\"1800\" height=\"1200\" src=\"https:\/\/greenoo.tw\/wp-content\/uploads\/2024\/06\/FDA\u5316\u599d\u54c1.jpeg\" class=\"attachment-large size-large wp-image-9728\" alt=\"\" srcset=\"https:\/\/greenoo.tw\/wp-content\/uploads\/2024\/06\/FDA\u5316\u599d\u54c1.jpeg 1800w, https:\/\/greenoo.tw\/wp-content\/uploads\/2024\/06\/FDA\u5316\u599d\u54c1-768x512.jpeg 768w, https:\/\/greenoo.tw\/wp-content\/uploads\/2024\/06\/FDA\u5316\u599d\u54c1-1536x1024.jpeg 1536w\" sizes=\"(max-width: 1800px) 100vw, 1800px\" \/>\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-1b69e07 elementor-widget elementor-widget-text-editor\" data-id=\"1b69e07\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<h2><strong>FDA Cosmetics Category<\/strong><\/h2><p>Under the Federal Food, Drug, and Cosmetic Act, all cosmetics sold in the U.S. market must comply with FDA regulations, including requirements for ingredients, safety, labeling, and packaging. Cosmetics that are not FDA-compliant may be considered illegal and may be detained or refused by U.S. Customs, and companies may face fines and legal liability.<span style=\"text-align: var(--text-align); background-color: var(--ast-global-color-4); color: var(--ast-global-color-3); font-size: 1rem;\">All businesses and individuals involved in the manufacture, packaging, importation, distribution, retailing, research and development, advertising and marketing of cosmetics are required to comply with the FDA's cosmetic compliance requirements. These requirements include safety of ingredients, accuracy of product labeling, safety of packaging materials, and sanitation standards for manufacturing facilities. Compliance with these regulations is not only a legal obligation, but also a necessary measure to protect consumer safety, enhance product competitiveness in the marketplace, and enhance corporate reputation.<\/span><\/p><p><span style=\"text-align: var(--text-align); background-color: var(--ast-global-color-4); color: var(--ast-global-color-3); font-size: 1rem;\">\b<\/span><span style=\"font-style: inherit; font-weight: inherit; text-align: var(--text-align); background-color: var(--ast-global-color-4); color: var(--ast-global-color-3);\">Documents required for filing: application form, Dun &amp; Bradstreet number, U.S. Authorized Agent, physical drawing of the product, and product package drawing.<\/span><span style=\"font-style: inherit; font-weight: inherit; text-align: var(--text-align); background-color: var(--ast-global-color-4); color: var(--ast-global-color-3);\">Docket Time: 7-14 days<\/span><\/p><p>Common products are face care products, body care products, sun care products, beauty and make-up products, nail care products, hair care products, styling products, hair coloring products, oral care products, perfume and aromatherapy products, men's care products, men's skincare products, baby and child care products, baby and child skincare products, baby and child cleansing products, other personal care products, and foot care products.<\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-10716ee e-grid e-con-boxed e-con e-parent\" data-id=\"10716ee\" data-element_type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-e2117f5 elementor-widget elementor-widget-image\" data-id=\"e2117f5\" data-element_type=\"widget\" data-widget_type=\"image.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t<img loading=\"lazy\" decoding=\"async\" width=\"640\" height=\"640\" src=\"https:\/\/greenoo.tw\/wp-content\/uploads\/2024\/06\/FDA-OTC.jpeg\" class=\"attachment-large size-large wp-image-9730\" alt=\"\" \/>\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-6b45e2c elementor-widget elementor-widget-text-editor\" data-id=\"6b45e2c\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<h2><strong>FDA Over-the-Counter Labeling Category\u00a0<\/strong><\/h2><p>Under the Federal Food, Drug, and Cosmetic Act, all OTC products sold in the U.S. market must comply with FDA regulations, including requirements for ingredients, safety, labeling, and packaging. OTC products that are not FDA-compliant are considered illegal and may be detained or refused by U.S. Customs, and companies may face fines and legal liability. All companies and individuals involved in the manufacture, packaging, importation, distribution, retailing, research and development, advertising and marketing of OTC drugs are required to comply with the FDA's OTC drug compliance requirements. Compliance with these regulations is not only a legal obligation, but also a necessary measure to protect consumer safety, enhance product competitiveness in the marketplace, and enhance corporate reputation.<\/p><p>Documents required for filing: Application form, Dun &amp; Bradstreet number, U.S. Authorized Agent<\/p><p>Docket Time: 14-20 days<\/p><p>Common products are cold and cough remedies, pain relievers, anti-allergy medications, digestive medications, skin care medications, eye care medications, oral care medications, gynecological care medications, other common over-the-counter medications, vitamin and mineral supplements, various vitamin tablets, mineral supplements, smoking cessation products, sleep aids, and more.<\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-186c80f e-flex e-con-boxed e-con e-parent\" data-id=\"186c80f\" data-element_type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div class=\"elementor-element elementor-element-d0539c2 e-con-full e-flex e-con e-child\" data-id=\"d0539c2\" data-element_type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-efc1eab elementor-widget elementor-widget-image\" data-id=\"efc1eab\" data-element_type=\"widget\" data-widget_type=\"image.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t<img loading=\"lazy\" decoding=\"async\" width=\"2560\" height=\"1440\" src=\"https:\/\/greenoo.tw\/wp-content\/uploads\/2024\/06\/FDA\u91ab\u7642\u5668\u68b0-scaled.jpeg\" class=\"attachment-large size-large wp-image-9729\" alt=\"\" srcset=\"https:\/\/greenoo.tw\/wp-content\/uploads\/2024\/06\/FDA\u91ab\u7642\u5668\u68b0-scaled.jpeg 2560w, https:\/\/greenoo.tw\/wp-content\/uploads\/2024\/06\/FDA\u91ab\u7642\u5668\u68b0-768x432.jpeg 768w, https:\/\/greenoo.tw\/wp-content\/uploads\/2024\/06\/FDA\u91ab\u7642\u5668\u68b0-1536x864.jpeg 1536w, https:\/\/greenoo.tw\/wp-content\/uploads\/2024\/06\/FDA\u91ab\u7642\u5668\u68b0-2048x1152.jpeg 2048w\" sizes=\"(max-width: 2560px) 100vw, 2560px\" \/>\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-c733fe1 e-con-full e-flex e-con e-child\" data-id=\"c733fe1\" data-element_type=\"container\">\n\t\t<div class=\"elementor-element elementor-element-daab079 e-flex e-con-boxed e-con e-child\" data-id=\"daab079\" data-element_type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-de39d18 elementor-widget elementor-widget-text-editor\" data-id=\"de39d18\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<h2><strong>FDA Class I Medical Devices<\/strong><\/h2><p>Under the Federal Food, Drug, and Cosmetic Act, all medical devices sold in the U.S. market must comply with FDA regulations, including design, manufacturing, packaging, labeling, and marketing requirements. Medical devices that are not FDA-compliant are considered illegal and may be detained by U.S. Customs or refused importation, and companies may face fines and legal liability.<\/p><p>All companies and individuals involved in the design, manufacture, assembly, packaging, importation, distribution, retailing, research and development, advertising and marketing of medical devices are required to comply with FDA's medical device compliance requirements. Compliance with these regulations is not only a legal obligation, but also a necessary measure to protect consumer and patient safety and to enhance the competitiveness of products in the marketplace and the reputation of the organization.<\/p><p>Documents required for filing: Application form, Dun &amp; Bradstreet number, U.S. Authorized Agent<\/p><p>Docket Time: 7-14 days<\/p><p>Common products are medical thermometers, medical blood pressure monitors, stethoscopes, etc., disinfection and sterilization equipment, medical gloves, disinfectants, sterilization packaging materials, etc., non-invasive diagnostic equipment, examination gloves, examination lamps, mouth mirrors, etc., test tube holders, measuring cylinders, pipettes, etc., crutches, walkers, wheelchairs, etc., physiotherapy equipment, such as exercise balls, rehabilitation belts, etc., electric toothbrushes, blood pressure monitors for home use, blood glucose meters for home use, etc, First aid kits, bandages, sterilized cotton balls, etc., dental surgical instruments, dental models, dental impression materials, etc., bandages, adhesive tapes, wound dressings, etc., orthotics, knee pads, wrist pads, etc., artificial tears, eye care kits, etc.<\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>","protected":false},"excerpt":{"rendered":"<p>The U.S. Food and Drug Administration (FDA, Food and Drug Administration) is a U.S. federal 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