{"id":33347,"date":"2024-12-04T10:27:59","date_gmt":"2024-12-04T09:27:59","guid":{"rendered":"https:\/\/www.thema-med.com\/?p=33347"},"modified":"2026-03-30T11:43:04","modified_gmt":"2026-03-30T09:43:04","slug":"practical-guide-to-the-classification-of-medical-devices-in-the-u-s","status":"publish","type":"post","link":"https:\/\/www.thema-med.com\/en\/2024\/12\/04\/practical-guide-to-the-classification-of-medical-devices-in-the-u-s\/","title":{"rendered":"Practical Guide to the Classification of Medical Devices in the U.S."},"content":{"rendered":"<div class=\"fusion-fullwidth fullwidth-box fusion-builder-row-1 fusion-flex-container has-pattern-background has-mask-background nonhundred-percent-fullwidth non-hundred-percent-height-scrolling\" style=\"--awb-border-radius-top-left:0px;--awb-border-radius-top-right:0px;--awb-border-radius-bottom-right:0px;--awb-border-radius-bottom-left:0px;--awb-flex-wrap:wrap;\" ><div class=\"fusion-builder-row fusion-row fusion-flex-align-items-flex-start fusion-flex-content-wrap\" style=\"max-width:1144px;margin-left: calc(-4% \/ 2 );margin-right: calc(-4% \/ 2 );\"><div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-0 fusion_builder_column_1_1 1_1 fusion-flex-column\" style=\"--awb-bg-size:cover;--awb-width-large:100%;--awb-margin-top-large:15px;--awb-spacing-right-large:1.92%;--awb-margin-bottom-large:15px;--awb-spacing-left-large:1.92%;--awb-width-medium:100%;--awb-order-medium:0;--awb-spacing-right-medium:1.92%;--awb-spacing-left-medium:1.92%;--awb-width-small:100%;--awb-order-small:0;--awb-spacing-right-small:1.92%;--awb-spacing-left-small:1.92%;\"><div class=\"fusion-column-wrapper fusion-column-has-shadow fusion-flex-justify-content-flex-start fusion-content-layout-column\"><div class=\"fusion-text fusion-text-1\"><h2>This White Paper is a concise and practical guide to the classification of Medical Devices in the United States, with a focus on marketing procedures. With the help of useful infographics and links, it will accompany you in determining the product risk class and the planning required to successfully enter the U.S. market.<\/h2>\n<\/div>\n<div class=\"wpcf7 no-js\" id=\"wpcf7-f33353-o1\" lang=\"en-US\" dir=\"ltr\" data-wpcf7-id=\"33353\">\n<div class=\"screen-reader-response\"><p role=\"status\" aria-live=\"polite\" aria-atomic=\"true\"><\/p> <ul><\/ul><\/div>\n<form action=\"\/en\/wp-json\/wp\/v2\/posts\/33347#wpcf7-f33353-o1\" method=\"post\" class=\"wpcf7-form init\" aria-label=\"Contact form\" novalidate=\"novalidate\" data-status=\"init\">\n<fieldset class=\"hidden-fields-container\"><input type=\"hidden\" name=\"_wpcf7\" value=\"33353\" \/><input type=\"hidden\" name=\"_wpcf7_version\" value=\"6.1.1\" \/><input type=\"hidden\" name=\"_wpcf7_locale\" value=\"en_US\" \/><input type=\"hidden\" name=\"_wpcf7_unit_tag\" value=\"wpcf7-f33353-o1\" \/><input type=\"hidden\" name=\"_wpcf7_container_post\" value=\"0\" \/><input 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PDF!\n<\/h5>\n<p><label> E-mail<br \/>\n<span class=\"wpcf7-form-control-wrap\" data-name=\"your-email\"><input size=\"40\" maxlength=\"400\" class=\"wpcf7-form-control wpcf7-email wpcf7-validates-as-required wpcf7-text wpcf7-validates-as-email\" aria-required=\"true\" aria-invalid=\"false\" value=\"\" type=\"email\" name=\"your-email\" \/><\/span> <\/label>\n<\/p>\n<p><label> Name<br \/>\n<span class=\"wpcf7-form-control-wrap\" data-name=\"your-name\"><input size=\"40\" maxlength=\"400\" class=\"wpcf7-form-control wpcf7-text wpcf7-validates-as-required\" aria-required=\"true\" aria-invalid=\"false\" value=\"\" type=\"text\" name=\"your-name\" \/><\/span> <\/label>\n<\/p>\n<p><label> Surname<br \/>\n<span class=\"wpcf7-form-control-wrap\" data-name=\"your-surname\"><input size=\"40\" maxlength=\"400\" class=\"wpcf7-form-control wpcf7-text wpcf7-validates-as-required\" aria-required=\"true\" aria-invalid=\"false\" value=\"\" type=\"text\" name=\"your-surname\" \/><\/span> <\/label>\n<\/p>\n<p><label> Company<br \/>\n<span class=\"wpcf7-form-control-wrap\" data-name=\"your-company\"><input size=\"40\" maxlength=\"400\" class=\"wpcf7-form-control wpcf7-text wpcf7-validates-as-required\" aria-required=\"true\" aria-invalid=\"false\" value=\"\" type=\"text\" name=\"your-company\" \/><\/span> <\/label>\n<\/p>\n<p><label>Country of your company<br \/>\n<span class=\"wpcf7-form-control-wrap\" data-name=\"Country\"><select class=\"wpcf7-form-control wpcf7-select wpcf7-validates-as-required\" aria-required=\"true\" aria-invalid=\"false\" name=\"Country\"><option value=\"\">&#8212;Please choose an option&#8212;<\/option><option value=\"Albania\">Albania<\/option><option value=\"Algeria\">Algeria<\/option><option value=\"Andorra\">Andorra<\/option><option value=\"Angola\">Angola<\/option><option value=\"Netherlands Antilles\">Netherlands Antilles<\/option><option value=\"Saudi Arabia\">Saudi Arabia<\/option><option value=\"Argentina\">Argentina<\/option><option value=\"Armenia\">Armenia<\/option><option value=\"Aruba\">Aruba<\/option><option value=\"Australia\">Australia<\/option><option value=\"Austria\">Austria<\/option><option value=\"Azerbaijan\">Azerbaijan<\/option><option value=\"Bahamas\">Bahamas<\/option><option value=\"Bahrain\">Bahrain<\/option><option value=\"Bangladesh\">Bangladesh<\/option><option value=\"Barbados\">Barbados<\/option><option value=\"Belgium\">Belgium<\/option><option value=\"Belize\">Belize<\/option><option value=\"Benin\">Benin<\/option><option value=\"Bermuda\">Bermuda<\/option><option value=\"Belarus\">Belarus<\/option><option value=\"Bhutan\">Bhutan<\/option><option value=\"Bolivia\">Bolivia<\/option><option value=\"Bosnia and Herzegovina\">Bosnia and Herzegovina<\/option><option value=\"Botswana\">Botswana<\/option><option value=\"Brazil\">Brazil<\/option><option value=\"Brunei Darussalam\">Brunei Darussalam<\/option><option value=\"Bulgaria\">Bulgaria<\/option><option value=\"Burkina Faso\">Burkina Faso<\/option><option value=\"Burundi\">Burundi<\/option><option value=\"Cambodia\">Cambodia<\/option><option value=\"Cameroon\">Cameroon<\/option><option value=\"Canada\">Canada<\/option><option value=\"Cape Verde\">Cape Verde<\/option><option value=\"Chad\">Chad<\/option><option value=\"Chile\">Chile<\/option><option value=\"China\">China<\/option><option value=\"Cyprus\">Cyprus<\/option><option value=\"Vatican City\">Vatican City<\/option><option value=\"Colombia\">Colombia<\/option><option value=\"Comoros\">Comoros<\/option><option value=\"Korea (North Korea)\">Korea (North Korea)<\/option><option value=\"Costa Rica\">Costa Rica<\/option><option value=\"Costa Rica\">Costa Rica<\/option><option value=\"Ivory Coast\">Ivory Coast<\/option><option value=\"Croatia\">Croatia<\/option><option value=\"Cuba\">Cuba<\/option><option value=\"Denmark\">Denmark<\/option><option value=\"Dominica\">Dominica<\/option><option value=\"Ecuador\">Ecuador<\/option><option value=\"Egypt\">Egypt<\/option><option value=\"Eire\">Eire<\/option><option value=\"El Salvador\">El Salvador<\/option><option value=\"United Arab Emirates\">United Arab Emirates<\/option><option value=\"Eritrea\">Eritrea<\/option><option value=\"Estonia\">Estonia<\/option><option value=\"Ethiopia\">Ethiopia<\/option><option value=\"Russian Federation\">Russian Federation<\/option><option value=\"Fiji\">Fiji<\/option><option value=\"Philippines\">Philippines<\/option><option value=\"Finland\">Finland<\/option><option value=\"France\">France<\/option><option value=\"Gabon\">Gabon<\/option><option value=\"Gambia\">Gambia<\/option><option value=\"Georgia\">Georgia<\/option><option value=\"Germany\">Germany<\/option><option value=\"Ghana\">Ghana<\/option><option value=\"Jamaica\">Jamaica<\/option><option value=\"Japan\">Japan<\/option><option value=\"Gibraltar\">Gibraltar<\/option><option value=\"Djibouti\">Djibouti<\/option><option value=\"Jordan\">Jordan<\/option><option value=\"Greece\">Greece<\/option><option value=\"Grenada\">Grenada<\/option><option value=\"Greenland\">Greenland<\/option><option value=\"Guadeloupe\">Guadeloupe<\/option><option value=\"Guam\">Guam<\/option><option value=\"Guatemala\">Guatemala<\/option><option value=\"Guinea\">Guinea<\/option><option value=\"Guinea-Bissau\">Guinea-Bissau<\/option><option value=\"Equatorial Guinea\">Equatorial Guinea<\/option><option value=\"Guyana\">Guyana<\/option><option value=\"French Guiana\">French Guiana<\/option><option value=\"Haiti\">Haiti<\/option><option value=\"Honduras\">Honduras<\/option><option value=\"Hong Kong\">Hong Kong<\/option><option value=\"India\">India<\/option><option value=\"Indonesia\">Indonesia<\/option><option value=\"Iran\">Iran<\/option><option value=\"Iraq\">Iraq<\/option><option value=\"Bouvet Island\">Bouvet Island<\/option><option value=\"Christmas Island\">Christmas Island<\/option><option value=\"Heard Island and McDonald Islands\">Heard Island and McDonald Islands<\/option><option value=\"Cayman Islands\">Cayman Islands<\/option><option value=\"Cocos Islands\">Cocos Islands<\/option><option value=\"Cook Islands\">Cook Islands<\/option><option value=\"Falkland Islands\">Falkland Islands<\/option><option value=\"Faroe Islands\">Faroe Islands<\/option><option value=\"Marshall Islands\">Marshall Islands<\/option><option value=\"Northern Mariana Islands\">Northern Mariana Islands<\/option><option value=\"United States Minor Outlying Islands\">United States Minor Outlying Islands<\/option><option value=\"Norfolk Island\">Norfolk Island<\/option><option value=\"Solomon Islands\">Solomon Islands<\/option><option value=\"Turks and Caicos Islands\">Turks and Caicos Islands<\/option><option value=\"Virgin Islands, U.S.\">Virgin Islands, U.S.<\/option><option value=\"Virgin Islands (British)\">Virgin Islands (British)<\/option><option value=\"Israel\">Israel<\/option><option value=\"Iceland\">Iceland<\/option><option value=\"Italy\">Italy<\/option><option value=\"Kazakhstan\">Kazakhstan<\/option><option value=\"Kenya\">Kenya<\/option><option value=\"Kyrgyzstan\">Kyrgyzstan<\/option><option value=\"Kiribati\">Kiribati<\/option><option value=\"Kosovo\">Kosovo<\/option><option value=\"Kuwait\">Kuwait<\/option><option value=\"Laos\">Laos<\/option><option value=\"Latvia\">Latvia<\/option><option value=\"Lesotho\">Lesotho<\/option><option value=\"Lebanon\">Lebanon<\/option><option value=\"Liberia\">Liberia<\/option><option value=\"Libya\">Libya<\/option><option value=\"Liechtenstein\">Liechtenstein<\/option><option value=\"Lithuania\">Lithuania<\/option><option value=\"Luxembourg\">Luxembourg<\/option><option value=\"Macao\">Macao<\/option><option value=\"Macedonia\">Macedonia<\/option><option value=\"Montenegro\">Montenegro<\/option><option value=\"Malawi\">Malawi<\/option><option value=\"Maldives\">Maldives<\/option><option value=\"Malaysia\">Malaysia<\/option><option value=\"Mali\">Mali<\/option><option value=\"Malta\">Malta<\/option><option value=\"Morocco\">Morocco<\/option><option value=\"Martinique\">Martinique<\/option><option value=\"Mauritania\">Mauritania<\/option><option value=\"Mauritius\">Mauritius<\/option><option value=\"Mayotte\">Mayotte<\/option><option value=\"Mexico\">Mexico<\/option><option value=\"Moldova\">Moldova<\/option><option value=\"Monaco\">Monaco<\/option><option value=\"Mongolia\">Mongolia<\/option><option value=\"Montserrat\">Montserrat<\/option><option value=\"Mozambique\">Mozambique<\/option><option value=\"Myanmar\">Myanmar<\/option><option value=\"Namibia\">Namibia<\/option><option value=\"Nicaragua\">Nicaragua<\/option><option value=\"Niger\">Niger<\/option><option value=\"Nigeria\">Nigeria<\/option><option value=\"Norway\">Norway<\/option><option value=\"New Caledonia\">New Caledonia<\/option><option value=\"New Zealand\">New Zealand<\/option><option value=\"Oman\">Oman<\/option><option value=\"The Netherlands\">The Netherlands<\/option><option value=\"Pakistan\">Pakistan<\/option><option value=\"Panama\">Panama<\/option><option value=\"Papua New Guinea\">Papua New Guinea<\/option><option value=\"Paraguay\">Paraguay<\/option><option value=\"Peru\">Peru<\/option><option value=\"Poland\">Poland<\/option><option value=\"Portugal\">Portugal<\/option><option value=\"Puerto Rico\">Puerto Rico<\/option><option value=\"Qatar\">Qatar<\/option><option value=\"United Kingdom\">United Kingdom<\/option><option value=\"Czech Republic\">Czech Republic<\/option><option value=\"Central African Republic\">Central African Republic<\/option><option value=\"Republic of Congo\">Republic of Congo<\/option><option value=\"Democratic Republic of Congo\">Democratic Republic of Congo<\/option><option value=\"Romania\">Romania<\/option><option value=\"Rwanda\">Rwanda<\/option><option value=\"Western Sahara\">Western Sahara<\/option><option value=\"San Marino\">San Marino<\/option><option value=\"Senegal\">Senegal<\/option><option value=\"Serbia\">Serbia<\/option><option value=\"Seychelles\">Seychelles<\/option><option value=\"Sierra Leone\">Sierra Leone<\/option><option value=\"Singapore\">Singapore<\/option><option value=\"Syria\">Syria<\/option><option value=\"Slovakia\">Slovakia<\/option><option value=\"Slovenia\">Slovenia<\/option><option value=\"Somalia\">Somalia<\/option><option value=\"Spain\">Spain<\/option><option value=\"Sri Lanka\">Sri Lanka<\/option><option value=\"Federated States of Micronesia\">Federated States of Micronesia<\/option><option value=\"United States of America\">United States of America<\/option><option value=\"South Africa\">South Africa<\/option><option value=\"Sudan\">Sudan<\/option><option value=\"Suriname\">Suriname<\/option><option value=\"Sweden\">Sweden<\/option><option value=\"Switzerland\">Switzerland<\/option><option value=\"Swaziland\">Swaziland<\/option><option value=\"Tajikistan\">Tajikistan<\/option><option value=\"Thailand\">Thailand<\/option><option value=\"Taiwan\">Taiwan<\/option><option value=\"Tanzania\">Tanzania<\/option><option value=\"Timor-Leste\">Timor-Leste<\/option><option value=\"Togo\">Togo<\/option><option value=\"Tonga\">Tonga<\/option><option value=\"Trinidad and Tobago\">Trinidad and Tobago<\/option><option value=\"Tunisia\">Tunisia<\/option><option value=\"Turkey\">Turkey<\/option><option value=\"Turkmenistan\">Turkmenistan<\/option><option value=\"Ukraine\">Ukraine<\/option><option value=\"Uganda\">Uganda<\/option><option value=\"Hungary\">Hungary<\/option><option value=\"Uruguay\">Uruguay<\/option><option value=\"Uzbekistan\">Uzbekistan<\/option><option value=\"Venezuela\">Venezuela<\/option><option value=\"Vietnam\">Vietnam<\/option><option value=\"Yemen\">Yemen<\/option><option value=\"Zambia\">Zambia<\/option><option value=\"Zimbabwe\">Zimbabwe<\/option><option value=\"-Other\">-Other<\/option><\/select><\/span><\/label>\n<\/p>\n<p><label> Role<br \/>\n<span class=\"wpcf7-form-control-wrap\" data-name=\"role\"><select class=\"wpcf7-form-control wpcf7-select wpcf7-validates-as-required\" aria-required=\"true\" aria-invalid=\"false\" name=\"role\"><option value=\"\">&#8212;Please choose an option&#8212;<\/option><option value=\"Purchase\">Purchase<\/option><option value=\"Sales\">Sales<\/option><option value=\"Marketing\">Marketing<\/option><option value=\"Admin\">Admin<\/option><option value=\"QA\/RA\">QA\/RA<\/option><option value=\"Management\">Management<\/option><option value=\"R &amp; D\">R &amp; D<\/option><option value=\"Other\">Other<\/option><\/select><\/span><\/label>\n<\/p>\n<p><span class=\"wpcf7-form-control-wrap\" data-name=\"privacy\"><span class=\"wpcf7-form-control wpcf7-acceptance\"><span class=\"wpcf7-list-item\"><label><input type=\"checkbox\" name=\"privacy\" value=\"1\" aria-invalid=\"false\" \/><span class=\"wpcf7-list-item-label\">Accept Privacy<\/span><\/label><\/span><\/span><\/span><br \/>\n<span 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class=\"fusion-alert-content\"><\/span><\/div><\/div>\n<\/form>\n<\/div>\n<\/div><\/div><\/div><\/div>\n","protected":false},"excerpt":{"rendered":"","protected":false},"author":115,"featured_media":33348,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"_monsterinsights_skip_tracking":false,"_monsterinsights_sitenote_active":false,"_monsterinsights_sitenote_note":"","_monsterinsights_sitenote_category":0,"footnotes":""},"categories":[1055],"tags":[],"class_list":["post-33347","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-library"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v26.0 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Practical Guide to the Classification of Medical Devices in the U.S. - Thema Med<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, 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