{"id":15458,"date":"2026-06-22T15:13:35","date_gmt":"2026-06-22T09:43:35","guid":{"rendered":"https:\/\/operonstrategist.com\/?p=15458"},"modified":"2026-06-22T15:13:35","modified_gmt":"2026-06-22T09:43:35","slug":"certificate-to-foreign-government-fda","status":"publish","type":"post","link":"https:\/\/operonstrategist.com\/sa-en\/certificate-to-foreign-government-fda\/","title":{"rendered":"Certificate To Foreign Government FDA"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-post\" data-elementor-id=\"15458\" class=\"elementor elementor-15458\" data-elementor-post-type=\"post\">\n\t\t\t\t<div class=\"elementor-element elementor-element-108bb41d e-flex e-con-boxed e-con e-parent\" data-id=\"108bb41d\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-131ced86 elementor-widget elementor-widget-heading\" data-id=\"131ced86\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h1 class=\"elementor-heading-title elementor-size-default\">Certificate To Foreign Government FDA<\/h1>\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-762a9519 e-flex e-con-boxed e-con e-parent\" data-id=\"762a9519\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div class=\"elementor-element elementor-element-35da51ad e-con-full e-flex e-con e-child\" data-id=\"35da51ad\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-2b31a41f elementor-widget elementor-widget-text-editor\" data-id=\"2b31a41f\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<p>\u00a0<\/p><p><span style=\"font-weight: 400;\">Certificate to foreign government FDA is required by many medical device market regulators in Asia, the Middle East, and Latin America in order to legally sell your product in their territories. A CFG confirms that your device has been cleared or approved for sale in the US. You can present your CFG to regulators in these markets as part of your medical device registration process. For the registration process or for the approval process you need experience Medical device compliance and regulatory service provider who can work with you to solve the raised issue if any.\u00a0\u00a0<\/span><\/p><p><span style=\"font-weight: 400;\">Before certain medical devices can be lawfully exported from the United States, some countries require American companies to obtain a Certificate to foreign government FDA (CFG). The FDA recently issued a final guidance titled \u201cProcess to Request a Review of FDA\u2019s Decision Not to Issue Certain Export Certificates for Devices,\u201d which details how to seek review of the denial of a CFG request, as well as the reasons the FDA will deny such a request and how to rectify them.<\/span><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-4296f77d e-con-full e-flex e-con e-child\" data-id=\"4296f77d\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t<div class=\"elementor-element elementor-element-47100242 e-con-full e-flex e-con e-child\" data-id=\"47100242\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-7e462b1 elementor-widget elementor-widget-heading\" data-id=\"7e462b1\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h4 class=\"elementor-heading-title elementor-size-default\">Regulatory Excellence for Global Medical Device Markets\n<\/h4>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-1c74233d elementor-widget elementor-widget-wpforms\" data-id=\"1c74233d\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"wpforms.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<div class=\"wpforms-container wpforms-container-full wpforms-render-modern\" id=\"wpforms-6203\"><form id=\"wpforms-form-6203\" class=\"wpforms-validate wpforms-form wpforms-ajax-form\" data-formid=\"6203\" method=\"post\" enctype=\"multipart\/form-data\" action=\"\/sa-en\/wp-json\/wp\/v2\/posts\/15458\" data-token=\"bb0d01854beaa56b1f74d7cc9636528a\" data-token-time=\"1782139740\"><noscript class=\"wpforms-error-noscript\">Please enable JavaScript in your browser to complete this form.<\/noscript><div id=\"wpforms-error-noscript\" style=\"display: none;\">Please enable JavaScript in your browser to complete this form.<\/div><div class=\"wpforms-field-container\">\t\t<div id=\"wpforms-6203-field_5-container\"\n\t\t\tclass=\"wpforms-field wpforms-field-text\"\n\t\t\tdata-field-type=\"text\"\n\t\t\tdata-field-id=\"5\"\n\t\t\t>\n\t\t\t<label class=\"wpforms-field-label\" for=\"wpforms-6203-field_5\" >Text Email Phone<\/label>\n\t\t\t<input type=\"text\" id=\"wpforms-6203-field_5\" class=\"wpforms-field-medium\" name=\"wpforms[fields][5]\" >\n\t\t<\/div>\n\t\t<div id=\"wpforms-6203-field_1-container\" class=\"wpforms-field wpforms-field-name\" data-field-id=\"1\"><label class=\"wpforms-field-label wpforms-label-hide\" for=\"wpforms-6203-field_1\" aria-hidden=\"false\">Name <span class=\"wpforms-required-label\" aria-hidden=\"true\">*<\/span><\/label><input type=\"text\" id=\"wpforms-6203-field_1\" class=\"wpforms-field-large wpforms-field-required\" name=\"wpforms[fields][1]\" placeholder=\"Name*\" aria-errormessage=\"wpforms-6203-field_1-error\" required><\/div><div id=\"wpforms-6203-field_2-container\" class=\"wpforms-field wpforms-field-email\" data-field-id=\"2\"><label class=\"wpforms-field-label wpforms-label-hide\" for=\"wpforms-6203-field_2\" aria-hidden=\"false\">Email <span class=\"wpforms-required-label\" aria-hidden=\"true\">*<\/span><\/label><input type=\"email\" id=\"wpforms-6203-field_2\" class=\"wpforms-field-large wpforms-field-required\" name=\"wpforms[fields][2]\" placeholder=\"Email*\" spellcheck=\"false\" aria-errormessage=\"wpforms-6203-field_2-error\" required><\/div><div id=\"wpforms-6203-field_3-container\" class=\"wpforms-field wpforms-field-phone\" data-field-id=\"3\"><label class=\"wpforms-field-label wpforms-label-hide\" for=\"wpforms-6203-field_3\" aria-hidden=\"false\">Phone <span class=\"wpforms-required-label\" aria-hidden=\"true\">*<\/span><\/label><input type=\"tel\" id=\"wpforms-6203-field_3\" class=\"wpforms-field-large wpforms-field-required wpforms-smart-phone-field\" data-rule-smart-phone-field=\"true\" name=\"wpforms[fields][3]\" placeholder=\"Phone*\" aria-label=\"Phone\" aria-errormessage=\"wpforms-6203-field_3-error\" required><\/div><div id=\"wpforms-6203-field_4-container\" class=\"wpforms-field wpforms-field-textarea\" data-field-id=\"4\"><label class=\"wpforms-field-label wpforms-label-hide\" for=\"wpforms-6203-field_4\" aria-hidden=\"false\">Paragraph Text <span class=\"wpforms-required-label\" aria-hidden=\"true\">*<\/span><\/label><textarea id=\"wpforms-6203-field_4\" class=\"wpforms-field-medium wpforms-field-required\" name=\"wpforms[fields][4]\" placeholder=\"Message\" aria-errormessage=\"wpforms-6203-field_4-error\" required><\/textarea><\/div><script>\n\t\t\t\t( function() {\n\t\t\t\t\tconst style = document.createElement( 'style' );\n\t\t\t\t\tstyle.appendChild( document.createTextNode( '#wpforms-6203-field_5-container { position: absolute !important; overflow: hidden !important; display: inline !important; height: 1px !important; width: 1px !important; z-index: -1000 !important; padding: 0 !important; } #wpforms-6203-field_5-container input { visibility: hidden; } #wpforms-conversational-form-page #wpforms-6203-field_5-container label { counter-increment: none; }' ) );\n\t\t\t\t\tdocument.head.appendChild( style );\n\t\t\t\t\tdocument.currentScript?.remove();\n\t\t\t\t} )();\n\t\t\t<\/script><\/div><!-- .wpforms-field-container --><div class=\"wpforms-recaptcha-container wpforms-is-recaptcha wpforms-is-recaptcha-type-v3\" ><input type=\"hidden\" name=\"wpforms[recaptcha]\" value=\"\"><\/div><div class=\"wpforms-submit-container\" ><input type=\"hidden\" name=\"wpforms[id]\" value=\"6203\"><input type=\"hidden\" name=\"page_title\" value=\"\"><input type=\"hidden\" name=\"page_url\" value=\"https:\/\/operonstrategist.com\/sa-en\/wp-json\/wp\/v2\/posts\/15458\"><input type=\"hidden\" name=\"url_referer\" value=\"\"><button type=\"submit\" name=\"wpforms[submit]\" id=\"wpforms-submit-6203\" class=\"wpforms-submit\" data-alt-text=\"Sending...\" data-submit-text=\"Submit\" aria-live=\"assertive\" value=\"wpforms-submit\">Submit<\/button><img decoding=\"async\" src=\"https:\/\/operonstrategist.com\/wp-content\/plugins\/wpforms\/assets\/images\/submit-spin.svg\" class=\"wpforms-submit-spinner\" style=\"display: none;\" width=\"26\" height=\"26\" alt=\"Loading\"><\/div><\/form><\/div>  <!-- .wpforms-container -->\t\t\t\t<\/div>\n\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<div class=\"elementor-element elementor-element-78366b86 e-flex e-con-boxed e-con e-parent\" data-id=\"78366b86\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-7d786b6e elementor-widget elementor-widget-text-editor\" data-id=\"7d786b6e\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<p><span style=\"font-weight: 400;\">Certificates to foreign government FDA are product specific and cost $175 for the original certificate. Each additional copy (official copies from the FDA are usually required) costs $15 per copy. Up to 50 pages (including the certificate, manufacturer page, and attachment pages) may be submitted for the same product. Each time an increment of 50 pages is exceeded, an additional fee of $175 will be charged.<\/span><\/p><p><span style=\"font-weight: 400;\">If the original is three pages long and you request an original and ten copies (33 total pages), then your charge will be $175 for the original and $150 for the ten copies\u2013a combined total of $325. However, original and 20 copies (63 pages) would exceed the 50-page limit, and you would be charged $175 for the first original and $225 for the first 15 copies. You would then be charged $175 for a second original and another $60 for four more copies.<\/span><\/p><p><span style=\"font-weight: 400;\">Do not wait until the last minute to request a Certificate to foreign government FDA. I recommend ordering 5-10 copies when you first register a product in the FURLS database, instead of waiting until you need it. The same is true of other types of certificates, such as CE Marking certificates from your Notified Body.<\/span><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-eb1dd88 elementor-widget elementor-widget-heading\" data-id=\"eb1dd88\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">What is a Certificate to foreign government FDA?\n<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-348ac77 elementor-widget elementor-widget-text-editor\" data-id=\"348ac77\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<p><span style=\"font-weight: 400;\">If you have a medical device that is registered and listed with the <a href=\"https:\/\/operonstrategist.com\/us-en\/elevateplus\/us-fda-510k-qmsr-registration\/\">US FDA<\/a>, then you can obtain a Certificate to Foreign Government from the US FDA.<\/span><\/p><p><span style=\"font-weight: 400;\">A Certificate to Foreign Government is a certificate issued by the US FDA verifying that your company may legally export the device, and the device may be distributed in the United States. Regulatory bodies in some countries request a \u201cCertificate of Free Sale.\u201d Still, these are issued by the US FDA for foods, while the agency issues Certificates to Foreign Governments for medical devices.<\/span><\/p><p><span style=\"font-weight: 400;\">The name of the certificate is not the same for all countries, and regulators use the terminology most familiar to their country. A Certificate to foreign government FDA (CFG) is, for the export of medical devices that can be legally marketed in the United States (U.S.) that are in compliance with the requirements of the Federal Food, Drug, and Cosmetic Act (FD&amp;C Act). Any medical device that is legally marketed in the U.S. may be exported anywhere in the world without prior FDA notification or approval.<\/span><\/p><p><span style=\"font-weight: 400;\">U.S. establishments may request a Certificate to foreign government FDA for any medical device that may be legally marketed in the U.S. A device may be legally marketed in the U.S\u2026<\/span><\/p><ul><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">The establishment must be registered with the FDA;<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">The device must be listed with the FDA;<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">The device must have a cleared Premarket Notification [(510(k)] , an approved Premarket Approval (PMA) Application (unless exempted by regulation), is a device that was on the market prior to May 28, 1976 (before the Medical Device Amendments to the FD&amp;C Act), or was granted a De Novo classification;<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">The device must meet the labeling requirements of Title 21 Code of Federal Regulations (CFR) Part 801 (21 CFR 801) or 21 CFR 809, if applicable;<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">The device must be manufactured in accordance with the Quality System (QS) regulation of<\/span><span style=\"font-weight: 400;\"> 21 CFR 820<\/span><span style=\"font-weight: 400;\">, unless exempted by regulation.<\/span><\/li><\/ul><p><span style=\"font-weight: 400;\">A Certificate to Foreign Government is a certificate issued by the US FDA verifying that your company may legally export the device, and the device may be distributed in the United States.<\/span><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-adc6d6b elementor-widget elementor-widget-heading\" data-id=\"adc6d6b\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">What is FDA registration?\n<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-d450ee7 elementor-widget elementor-widget-text-editor\" data-id=\"d450ee7\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<p><span style=\"font-weight: 400;\">FDA Registration mandated by the United States Food and Drug Administration responsible for protecting public health from various consumer products such as Drugs, Medical devices, Food &amp; Cosmetics. Product registration plays a vital role in the path of a product that is on its way to the market. If FDA found your unregistered product, it will issue a cease and desist order removing the products from the market.<\/span><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-d7446ed elementor-widget elementor-widget-heading\" data-id=\"d7446ed\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">What is the difference between FDA approval and FDA registration?\n<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-10a21f2 elementor-widget elementor-widget-text-editor\" data-id=\"10a21f2\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<p><span style=\"font-weight: 400;\">REGISTRATION:<\/span><\/p><ul><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Registration means FDA is aware of the manufacturer and their devices<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">The manufacturer cannot claim the device is FDA CLEARED or APPROVED<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">They cannot use the FDA logo in labelling their device.<\/span><\/span><p>\u00a0<\/p><\/li><\/ul><p><span style=\"font-weight: 400;\">APPROVAL:<\/span><\/p><ul><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">FDA approval means high risk devices are well tested and approved.<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\"><a href=\"https:\/\/operonstrategist.com\/classifying-a-class-iii-medical-device\/\">Class III medical devices<\/a> fall under this category<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">It requires a statement or a proof that the high risk devices are safe to use and manufacture.<\/span><\/li><\/ul><p><span style=\"font-weight: 400;\">As a <\/span><a href=\"https:\/\/operonstrategist.com\/\"><span style=\"font-weight: 400;\">Medical device regulatory consultant<\/span><\/a><span style=\"font-weight: 400;\"> we provide regulatory services to manufacturer which helps them to achieve better.<\/span><\/p>\t\t\t\t\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","protected":false},"excerpt":{"rendered":"<p>Certificate to foreign government FDA is required by many medical device market regulators in Asia, the Middle East, and Latin America in order to legally sell your product in their territories. A CFG confirms that your device has been cleared or approved for sale in the US. You can present your CFG to regulators in [&hellip;]<\/p>\n","protected":false},"author":2,"featured_media":15528,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[22],"tags":[],"class_list":["post-15458","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-us-fda"],"_links":{"self":[{"href":"https:\/\/operonstrategist.com\/sa-en\/wp-json\/wp\/v2\/posts\/15458","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/operonstrategist.com\/sa-en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/operonstrategist.com\/sa-en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/operonstrategist.com\/sa-en\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/operonstrategist.com\/sa-en\/wp-json\/wp\/v2\/comments?post=15458"}],"version-history":[{"count":1,"href":"https:\/\/operonstrategist.com\/sa-en\/wp-json\/wp\/v2\/posts\/15458\/revisions"}],"predecessor-version":[{"id":15529,"href":"https:\/\/operonstrategist.com\/sa-en\/wp-json\/wp\/v2\/posts\/15458\/revisions\/15529"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/operonstrategist.com\/sa-en\/wp-json\/wp\/v2\/media\/15528"}],"wp:attachment":[{"href":"https:\/\/operonstrategist.com\/sa-en\/wp-json\/wp\/v2\/media?parent=15458"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/operonstrategist.com\/sa-en\/wp-json\/wp\/v2\/categories?post=15458"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/operonstrategist.com\/sa-en\/wp-json\/wp\/v2\/tags?post=15458"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}