{"id":10860,"date":"2023-05-05T14:21:57","date_gmt":"2023-05-05T17:21:57","guid":{"rendered":"https:\/\/passarini.com.br\/why-latin-america\/"},"modified":"2023-05-09T09:03:14","modified_gmt":"2023-05-09T12:03:14","slug":"market-and-regulation-of-medical-devices-in-mexico","status":"publish","type":"post","link":"https:\/\/passarini.com.br\/en\/market-and-regulation-of-medical-devices-in-mexico\/","title":{"rendered":"The market and regulation of medical devices in Mexico"},"content":{"rendered":"<p><div class=\"fusion-fullwidth fullwidth-box fusion-builder-row-1 hundred-percent-fullwidth non-hundred-percent-height-scrolling\" style=\"--awb-background-position:left center;--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-padding-top:0px;--awb-padding-right:0px;--awb-padding-bottom:0px;--awb-padding-left:0px;--awb-margin-top:0px;--awb-margin-bottom:0px;--awb-flex-wrap:wrap;\" ><div class=\"fusion-builder-row fusion-row\"><div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-0 fusion_builder_column_1_1 1_1 fusion-one-full fusion-column-first fusion-column-last\" style=\"--awb-padding-top:0px;--awb-padding-right:0px;--awb-padding-bottom:0px;--awb-padding-left:0px;--awb-bg-size:cover;--awb-margin-bottom:0px;\"><div class=\"fusion-column-wrapper fusion-flex-column-wrapper-legacy\"><div class=\"fusion-slider-sc fusion-flexslider-loading flexslider flexslider-hover-type-none\" data-slideshow_autoplay=\"1\" data-slideshow_smooth_height=\"0\" data-slideshow_speed=\"7000\" style=\"max-width:100%;height:100%;\"><ul class=\"slides\"><li class=\"image\"><span class=\"fusion-image-hover-element hover-type-none\"><img decoding=\"async\" src=\"https:\/\/passarini.com.br\/wp-content\/uploads\/2020\/10\/1920x500_informativos_noticias-1.webp\" alt=\"Banner Informativos Blog da Passarini\" width=\"1560\" height=\"406\" class=\"wp-image-8654\" \/><\/span><\/li><\/ul><\/div><div class=\"fusion-clearfix\"><\/div><\/div><\/div><\/div><\/div><div class=\"fusion-fullwidth fullwidth-box fusion-builder-row-2 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-padding-top:10px;--awb-flex-wrap:wrap;\" ><div class=\"fusion-builder-row fusion-row\"><div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-1 fusion_builder_column_3_4 3_4 fusion-three-fourth fusion-column-first\" style=\"--awb-bg-size:cover;width:75%;width:calc(75% - ( ( 4% ) * 0.75 ) );margin-right: 4%;\"><div class=\"fusion-column-wrapper fusion-flex-column-wrapper-legacy\"><div class=\"fusion-text fusion-text-1\"><h2 class=\"headingpostinterno\">The market and regulation of medical devices in Mexico<\/h2>\n<p>Mexico is a country located in North America, neighboring the United States and the countries of Central America. It has more than 126 million inhabitants who have a public health system covered by the IMSS (Mexican Institute of Social Security) and a private system covered by private insurance plans or cash payments. Along with Brazil, Mexico ranks among the top 10 countries with the largest number of hospitals.<\/p>\n<p>The medical device industry in Mexico is one of the most relevant globally, as the country is the 6th largest exporter and 10th largest importer worldwide. During 2020, Mexico exported $18.6 billion in medical products, of which Baja California (a Mexican state) contributed approximately 50%, maintaining its position as not only a national, but also a Latin American leader.<\/p>\n<p>The Mexican domestic market, according to research conducted by the Massachusetts International Trade and Research Office, has a growing demand for products for the care of degenerative diseases, such as personal glucose and cholesterol monitors, glucose control products, massagers and weight control devices, as well as anesthesia and respiratory therapy equipment, cardiac simulators, defibrillators, diagnostic equipment, electrocardiographs, electro surgery devices, gamma X-ray equipment, incubators, laser surgical devices, MRI machines, suction pumps, ultrasound devices, and endoscopes.<\/p>\n<p>Mexico has a very robust regulation of medical devices, which is regulated by COFEPRIS (Federal Commission for the Protection against Sanitary Risks), and has legislation that has been adapting to international medical device standards, as well as aligning with international regulatory harmonization.<\/p>\n<p>Product registration in Mexico can be done through traditional entry or through an equivalence agreement that accepts FDA, Canada Health or Japan registration, called Fast Track, which results in faster and easier approval.<\/p>\n<\/div><div class=\"fusion-text fusion-text-2\"><p>Caso possua interesse em registrar em um mercado t\u00e3o promissor e abundante como o M\u00e9xico, entre em contato com a Passarini Group! Iremos lhe auxiliar na obten\u00e7\u00e3o de sua aprova\u00e7\u00e3o!<\/p>\n<p>Mas se ainda ficou com d\u00favida, fale com os nossos especialistas atrav\u00e9s do e-mail: <span style=\"color: #0000ff;\"><strong><a style=\"color: #0000ff;\" href=\"mailto:contato@passarini.com.br?subject=Enquadramento%20de%20porte%20ANVISA\">contato@passarini.com.br<\/a><\/strong>.<\/span><\/p>\n<h2><span style=\"color: #000000;\"><strong>Passarini Group<\/strong><\/span><\/h2>\n<p>Publicado em: 05\/05\/2023 &#8211; Fonte: <a href=\"https:\/\/amid.org.mx\/industria-de-dispositivos-medicos-es-exportador-estrella-ahora-quieres-vender-mas-en-mexico\/\">AMID.ORG<\/a><\/p>\n<\/div><div class=\"fusion-sharing-box fusion-sharing-box-1 boxed-icons has-taglines layout-floated layout-medium-floated layout-small-stacked\" style=\"background-color:#f6f6f6;--awb-separator-border-sizes:0px;--awb-layout:row;--awb-alignment-small:space-between;--awb-stacked-align-small:center;\" data-title=\"Passarini Group\" data-description=\"The market and regulation of medical devices in Mexico\r\nMexico is a country located in North America, neighboring the United States and the countries of Central America. It has more than 126 million inhabitants who have a public health system covered by the IMSS (Mexican Institute of Social Security) and a\" data-link=\"https:\/\/passarini.com.br\/en\/?p=10860\"><h4 class=\"tagline\" style=\"color:#333333;\">To share<\/h4><div class=\"fusion-social-networks sharingbox-shortcode-icon-wrapper sharingbox-shortcode-icon-wrapper-1 boxed-icons\"><span><a href=\"https:\/\/www.facebook.com\/sharer.php?u=https%3A%2F%2Fpassarini.com.br%2Fen%2F%3Fp%3D10860&amp;t=Passarini%20Group\" target=\"_blank\" rel=\"noreferrer\" title=\"Facebook\" aria-label=\"Facebook\" data-placement=\"top\" data-toggle=\"tooltip\" data-title=\"Facebook\"><i class=\"fusion-social-network-icon fusion-tooltip fusion-facebook awb-icon-facebook\" style=\"color:#ffffff;background-color:#3b5998;border-color:#3b5998;border-radius:4px;\" aria-hidden=\"true\"><\/i><\/a><\/span><span><a href=\"https:\/\/x.com\/intent\/post?text=Passarini%20Group&amp;url=https%3A%2F%2Fpassarini.com.br%2Fen%2F%3Fp%3D10860\" target=\"_blank\" rel=\"noopener noreferrer\" title=\"X\" aria-label=\"X\" data-placement=\"top\" data-toggle=\"tooltip\" data-title=\"X\"><i class=\"fusion-social-network-icon fusion-tooltip fusion-twitter awb-icon-twitter\" style=\"color:#ffffff;background-color:#000000;border-color:#000000;border-radius:4px;\" aria-hidden=\"true\"><\/i><\/a><\/span><span><a href=\"https:\/\/www.linkedin.com\/shareArticle?mini=true&amp;url=https%3A%2F%2Fpassarini.com.br%2Fen%2F%3Fp%3D10860&amp;title=Passarini%20Group&amp;summary=The%20market%20and%20regulation%20of%20medical%20devices%20in%20Mexico%0D%0AMexico%20is%20a%20country%20located%20in%20North%20America%2C%20neighboring%20the%20United%20States%20and%20the%20countries%20of%20Central%20America.%20It%20has%20more%20than%20126%20million%20inhabitants%20who%20have%20a%20public%20health%20system%20covered%20by%20the%20IMSS%20%28Mexican%20Institute%20of%20Social%20Security%29%20and%20a\" target=\"_blank\" rel=\"noopener noreferrer\" title=\"LinkedIn\" aria-label=\"LinkedIn\" data-placement=\"top\" data-toggle=\"tooltip\" data-title=\"LinkedIn\"><i class=\"fusion-social-network-icon fusion-tooltip fusion-linkedin awb-icon-linkedin\" style=\"color:#ffffff;background-color:#0077b5;border-color:#0077b5;border-radius:4px;\" aria-hidden=\"true\"><\/i><\/a><\/span><span><a href=\"mailto:?subject=Passarini%20Group&amp;body=https%3A%2F%2Fpassarini.com.br%2Fen%2F%3Fp%3D10860\" target=\"_self\" title=\"Email\" aria-label=\"Email\" data-placement=\"top\" data-toggle=\"tooltip\" data-title=\"Email\"><i class=\"fusion-social-network-icon fusion-tooltip fusion-mail awb-icon-mail\" style=\"color:#ffffff;background-color:#000000;border-color:#000000;border-radius:4px;\" aria-hidden=\"true\"><\/i><\/a><\/span><\/div><\/div><div class=\"fusion-clearfix\"><\/div><\/div><\/div><div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-2 fusion_builder_column_1_4 1_4 fusion-one-fourth fusion-column-last\" style=\"--awb-bg-size:cover;width:25%;width:calc(25% - ( ( 4% ) * 0.25 ) );\"><div class=\"fusion-column-wrapper fusion-flex-column-wrapper-legacy\"><div class=\"fusion-text fusion-text-3\"><h3 data-fontsize=\"22\" data-lineheight=\"48\"><strong>More news:<\/strong><\/h3>\n<\/div><div class=\"fusion-recent-posts fusion-recent-posts-1 avada-container layout-default layout-columns-1\"><section class=\"fusion-columns columns fusion-columns-1 columns-1\"><article class=\"post fusion-column column col col-lg-12 col-md-12 col-sm-12\"><div class=\"recent-posts-content\"><span class=\"vcard\" style=\"display: none;\"><span class=\"fn\"><a href=\"https:\/\/passarini.com.br\/en\/author\/anderson\/\" title=\"Posts by Anderson Vieira\" rel=\"author\">Anderson Vieira<\/a><\/span><\/span><span class=\"updated\" style=\"display:none;\">2026-02-12T17:31:31-03:00<\/span><h4 class=\"entry-title\"><a href=\"https:\/\/passarini.com.br\/en\/siud-anvisa-udi-medical-devices-brazil-2026-deadlines\/\">SIUD Anvisa: The Complete Guide to the New UDI Database and 2026 Deadlines<\/a><\/h4><\/div><\/article><article class=\"post fusion-column column col col-lg-12 col-md-12 col-sm-12\"><div class=\"recent-posts-content\"><span class=\"vcard\" style=\"display: none;\"><span class=\"fn\"><a href=\"https:\/\/passarini.com.br\/en\/author\/anderson\/\" title=\"Posts by Anderson Vieira\" rel=\"author\">Anderson Vieira<\/a><\/span><\/span><span class=\"updated\" style=\"display:none;\">2026-02-02T16:07:37-03:00<\/span><h4 class=\"entry-title\"><a href=\"https:\/\/passarini.com.br\/en\/fda-qmsr-medical-device-regulation-update\/\">FDA Unleashes New QMSR: A Game Changer for Medical Device Quality Management<\/a><\/h4><\/div><\/article><article class=\"post fusion-column column col col-lg-12 col-md-12 col-sm-12\"><div class=\"recent-posts-content\"><span class=\"vcard\" style=\"display: none;\"><span class=\"fn\"><a href=\"https:\/\/passarini.com.br\/en\/author\/anderson\/\" title=\"Posts by Anderson Vieira\" rel=\"author\">Anderson Vieira<\/a><\/span><\/span><span class=\"updated\" style=\"display:none;\">2025-11-26T16:10:51-03:00<\/span><h4 class=\"entry-title\"><a href=\"https:\/\/passarini.com.br\/en\/simplified-process-trap-anvisa-denials-class-i-ii\/\">The Simplified Process Trap: Why Do Classes I and II Generate More Rejections at ANVISA?<\/a><\/h4><\/div><\/article><article class=\"post fusion-column column col col-lg-12 col-md-12 col-sm-12\"><div class=\"recent-posts-content\"><span class=\"vcard\" style=\"display: none;\"><span class=\"fn\"><a href=\"https:\/\/passarini.com.br\/en\/author\/anderson\/\" title=\"Posts by Anderson Vieira\" rel=\"author\">Anderson Vieira<\/a><\/span><\/span><span class=\"updated\" style=\"display:none;\">2025-11-06T10:58:24-03:00<\/span><h4 class=\"entry-title\"><a href=\"https:\/\/passarini.com.br\/en\/anvisa-new-scheduling-system-compliance-rules\/\">New ANVISA System: 3 Essential Compliance Rules and the 5-Year Risk<\/a><\/h4><\/div><\/article><article class=\"post fusion-column column col col-lg-12 col-md-12 col-sm-12\"><div class=\"recent-posts-content\"><span class=\"vcard\" style=\"display: none;\"><span class=\"fn\"><a href=\"https:\/\/passarini.com.br\/en\/author\/anderson\/\" title=\"Posts by Anderson Vieira\" rel=\"author\">Anderson Vieira<\/a><\/span><\/span><span class=\"updated\" style=\"display:none;\">2025-10-28T17:48:37-03:00<\/span><h4 class=\"entry-title\"><a href=\"https:\/\/passarini.com.br\/en\/anvisa-automates-afe-ae-end-of-waiting\/\">ANVISA Revolution: AFE and AE Are Now Automatic!<\/a><\/h4><\/div><\/article><article class=\"post fusion-column column col col-lg-12 col-md-12 col-sm-12\"><div class=\"recent-posts-content\"><span class=\"vcard\" style=\"display: none;\"><span class=\"fn\"><a href=\"https:\/\/passarini.com.br\/en\/author\/anderson\/\" title=\"Posts by Anderson Vieira\" rel=\"author\">Anderson Vieira<\/a><\/span><\/span><span class=\"updated\" style=\"display:none;\">2025-11-26T16:11:15-03:00<\/span><h4 class=\"entry-title\"><a href=\"https:\/\/passarini.com.br\/en\/devices-medical-new-export-route\/\">Devices to America: How U.S. Tariffs Are Changing Medical Device Exports<\/a><\/h4><\/div><\/article><\/section><\/div><div class=\"fusion-clearfix\"><\/div><\/div><\/div><\/div><\/div><\/p>\n","protected":false},"excerpt":{"rendered":"","protected":false},"author":16,"featured_media":10873,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[244,260],"tags":[261,263,258,262,232,153],"class_list":["post-10860","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-cofepris-en","category-mexico-en-2","tag-cofepris-en","tag-imss-en","tag-latam-en","tag-mexico-en","tag-regularization-of-medical-devices","tag-regulatorio-en"],"_links":{"self":[{"href":"https:\/\/passarini.com.br\/en\/wp-json\/wp\/v2\/posts\/10860","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/passarini.com.br\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/passarini.com.br\/en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/passarini.com.br\/en\/wp-json\/wp\/v2\/users\/16"}],"replies":[{"embeddable":true,"href":"https:\/\/passarini.com.br\/en\/wp-json\/wp\/v2\/comments?post=10860"}],"version-history":[{"count":8,"href":"https:\/\/passarini.com.br\/en\/wp-json\/wp\/v2\/posts\/10860\/revisions"}],"predecessor-version":[{"id":10881,"href":"https:\/\/passarini.com.br\/en\/wp-json\/wp\/v2\/posts\/10860\/revisions\/10881"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/passarini.com.br\/en\/wp-json\/wp\/v2\/media\/10873"}],"wp:attachment":[{"href":"https:\/\/passarini.com.br\/en\/wp-json\/wp\/v2\/media?parent=10860"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/passarini.com.br\/en\/wp-json\/wp\/v2\/categories?post=10860"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/passarini.com.br\/en\/wp-json\/wp\/v2\/tags?post=10860"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}