{"id":679,"date":"2020-02-24T14:38:29","date_gmt":"2020-02-24T14:38:29","guid":{"rendered":"https:\/\/veraqueconsulting.com\/mx\/?p=679"},"modified":"2026-02-09T19:11:10","modified_gmt":"2026-02-09T19:11:10","slug":"medical-device-regulatory-overview-in-mexico-veraque","status":"publish","type":"post","link":"https:\/\/veraqueconsulting.com\/mx\/medical-device-regulatory-overview-in-mexico-veraque\/","title":{"rendered":"Mexico&#8217;s Medical Device Regulatory Overview"},"content":{"rendered":"<p><span data-contrast=\"none\">Considering Mexico as the second largest medical device market in Latin America, you may find it as a good alternative to expand your business. Nevertheless, there are a few considerations to register your products in the country. In this overview, we will describe briefly what you need to register your medical device in Mexico and some key facts to consider making this process easier for you and your team.<\/span><span data-ccp-props=\"{&quot;335557856&quot;:16777215,&quot;335559739&quot;:216}\">\u00a0<\/span><\/p>\n<p>&nbsp;<\/p>\n<p><span data-contrast=\"none\">Medical Devices in Mexico are regulated by <\/span><a href=\"https:\/\/www.gob.mx\/cofepris\" target=\"_blank\" rel=\"noopener\"><b><span data-contrast=\"none\">COFEPRIS<\/span><\/b><\/a><span data-contrast=\"none\"> (<\/span><b><span data-contrast=\"none\">CO<\/span><\/b><span data-contrast=\"none\">misi\u00f3n <\/span><b><span data-contrast=\"none\">FE<\/span><\/b><span data-contrast=\"none\">deral para la <\/span><b><span data-contrast=\"none\">P<\/span><\/b><span data-contrast=\"none\">rotecci\u00f3n contra <\/span><b><span data-contrast=\"none\">R<\/span><\/b><span data-contrast=\"none\">iesgos <\/span><b><span data-contrast=\"none\">S<\/span><\/b><span data-contrast=\"none\">anitarios), a Federal Commission that belongs to the Ministry of Health.<\/span><span data-ccp-props=\"{&quot;335557856&quot;:16777215,&quot;335559739&quot;:216}\">\u00a0<\/span><\/p>\n<p>&nbsp;<\/p>\n<p><span data-contrast=\"none\">Most of the times, a medical device in other countries is also considered a medical device in Mexico. Nevertheless, it is necessary to confirm the <\/span><a href=\"https:\/\/veraqueconsulting.com\/mx\/classification-and-grouping-ultimate-guide\/\" target=\"_blank\" rel=\"noopener\"><span data-contrast=\"none\">classification and grouping<\/span><\/a><span data-contrast=\"none\"> \u00a0through local legal guidelines. This is the first step we recommend you to take.<\/span><span data-ccp-props=\"{&quot;335557856&quot;:16777215,&quot;335559739&quot;:216}\">\u00a0<\/span><\/p>\n<p><span data-ccp-props=\"{&quot;335557856&quot;:16777215,&quot;335559739&quot;:216}\">\u00a0<\/span><\/p>\n<h3><\/h3>\n<h3><b><span data-contrast=\"none\">Regulatory Pathways<\/span><\/b><span data-ccp-props=\"{&quot;335557856&quot;:16777215,&quot;335559739&quot;:216}\">\u00a0<\/span><\/h3>\n<p><span data-contrast=\"none\">As in other countries, there are different <\/span><a href=\"https:\/\/veraqueconsulting.com\/mx\/ultimate-guide-for-regulatory-affairs-in-mexico\/#routes\" target=\"_blank\" rel=\"noopener\"><span data-contrast=\"none\">regulatory pathways<\/span><\/a><span data-contrast=\"none\"> to register a medical device:<\/span><span data-ccp-props=\"{&quot;335557856&quot;:16777215,&quot;335559739&quot;:216}\">\u00a0<\/span><\/p>\n<ul>\n<li data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"5\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559685&quot;:1080,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;\uf0b7&quot;,&quot;469777815&quot;:&quot;hybridMultilevel&quot;}\" data-aria-posinset=\"1\" data-aria-level=\"1\"><strong>Standard Process.\u00a0<\/strong><\/li>\n<\/ul>\n<ul>\n<li style=\"list-style-type: none\">\n<ul>\n<li data-leveltext=\"o\" data-font=\"Courier New\" data-listid=\"5\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559685&quot;:1800,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Courier New&quot;,&quot;469769242&quot;:[9675],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;o&quot;,&quot;469777815&quot;:&quot;hybridMultilevel&quot;}\" data-aria-posinset=\"1\" data-aria-level=\"2\"><span data-contrast=\"none\">Time: Even though there are official timeframes, you should consider at least <\/span><b><span data-contrast=\"none\">16 months<\/span><\/b><span data-contrast=\"none\"> to receive a response.<\/span><span data-ccp-props=\"{&quot;335557856&quot;:16777215,&quot;335559739&quot;:0}\">\u00a0<\/span><\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<ul>\n<li data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"4\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559685&quot;:1080,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;\uf0b7&quot;,&quot;469777815&quot;:&quot;hybridMultilevel&quot;}\" data-aria-posinset=\"1\" data-aria-level=\"1\"><strong>Equivalency agreement.\u00a0<\/strong><\/li>\n<\/ul>\n<ul>\n<li style=\"list-style-type: none\">\n<ul>\n<li data-leveltext=\"o\" data-font=\"Courier New\" data-listid=\"4\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559685&quot;:1800,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Courier New&quot;,&quot;469769242&quot;:[9675],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;o&quot;,&quot;469777815&quot;:&quot;hybridMultilevel&quot;}\" data-aria-posinset=\"1\" data-aria-level=\"2\">Applicable for products approved by any IMDRF Management Committee Regulatory Agency. ( previously limited to the US, Canada and Japan).<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<ul>\n<li style=\"list-style-type: none\">\n<ul>\n<li style=\"list-style-type: none\">\n<ul>\n<li data-leveltext=\"o\" data-font=\"Courier New\" data-listid=\"4\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559685&quot;:1800,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Courier New&quot;,&quot;469769242&quot;:[9675],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;o&quot;,&quot;469777815&quot;:&quot;hybridMultilevel&quot;}\" data-aria-posinset=\"2\" data-aria-level=\"2\"><span data-contrast=\"none\">For more information visit: <\/span><a href=\"https:\/\/veraqueconsulting.com\/mx\/mexicos-expanded-equivalency-agreement-for-medical-devices-key-implications\/\" target=\"_blank\" rel=\"noopener\"><span data-contrast=\"none\">Mexico\u2019s Expanded Equivalency Agreement: Key Implications<\/span><\/a><span data-ccp-props=\"{&quot;335557856&quot;:16777215,&quot;335559739&quot;:0}\">\u00a0<\/span><\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<p><span data-ccp-props=\"{&quot;335557856&quot;:16777215,&quot;335559685&quot;:1800,&quot;335559739&quot;:0}\">\u00a0<\/span><\/p>\n<h3><b><span data-contrast=\"none\">Holding<\/span><\/b><span data-ccp-props=\"{&quot;134245418&quot;:true,&quot;134245529&quot;:true,&quot;335557856&quot;:16777215,&quot;335559738&quot;:120,&quot;335559739&quot;:240}\">\u00a0<\/span><\/h3>\n<p><span data-contrast=\"none\">In Mexico it is necessary to have a <\/span><a href=\"https:\/\/veraqueconsulting.com\/mx\/holding-services\/?\" target=\"_blank\" rel=\"noopener\"><span data-contrast=\"none\">Registration Holder<\/span><\/a><span data-contrast=\"none\"> who owns the registration. The Mexican Registration Holder (MRH) also must be a Mexican legal entity.<\/span><span data-ccp-props=\"{&quot;335557856&quot;:16777215,&quot;335559739&quot;:216}\">\u00a0<\/span><\/p>\n<ul>\n<li data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"3\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559685&quot;:1080,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;\uf0b7&quot;,&quot;469777815&quot;:&quot;hybridMultilevel&quot;}\" data-aria-posinset=\"1\" data-aria-level=\"1\"><span data-contrast=\"none\">Main responsibilities of the holder:<\/span><span data-ccp-props=\"{&quot;335557856&quot;:16777215,&quot;335559739&quot;:0}\">\u00a0<\/span><\/li>\n<\/ul>\n<ul>\n<li style=\"list-style-type: none\">\n<ul>\n<li data-leveltext=\"o\" data-font=\"Courier New\" data-listid=\"3\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559685&quot;:1800,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Courier New&quot;,&quot;469769242&quot;:[9675],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;o&quot;,&quot;469777815&quot;:&quot;hybridMultilevel&quot;}\" data-aria-posinset=\"1\" data-aria-level=\"2\"><span data-contrast=\"none\">To be the main point of contact in Mexico with COFEPRIS.<\/span><span data-ccp-props=\"{&quot;335557856&quot;:16777215,&quot;335559739&quot;:0}\">\u00a0<\/span><\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<ul>\n<li style=\"list-style-type: none\">\n<ul>\n<li data-leveltext=\"o\" data-font=\"Courier New\" data-listid=\"3\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559685&quot;:1800,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Courier New&quot;,&quot;469769242&quot;:[9675],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;o&quot;,&quot;469777815&quot;:&quot;hybridMultilevel&quot;}\" data-aria-posinset=\"2\" data-aria-level=\"2\"><span data-contrast=\"none\">Applying for any process with COFEPRIS, related to the registrations or any product.<\/span><span data-ccp-props=\"{&quot;335557856&quot;:16777215,&quot;335559739&quot;:0}\">\u00a0<\/span><\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<ul>\n<li style=\"list-style-type: none\">\n<ul>\n<li data-leveltext=\"o\" data-font=\"Courier New\" data-listid=\"3\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559685&quot;:1800,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Courier New&quot;,&quot;469769242&quot;:[9675],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;o&quot;,&quot;469777815&quot;:&quot;hybridMultilevel&quot;}\" data-aria-posinset=\"3\" data-aria-level=\"2\"><span data-contrast=\"none\">Reporting any incident, in terms of <\/span><a href=\"https:\/\/veraqueconsulting.com\/mx\/technovigilance-for-medical-devices-in-mexico\/\" target=\"_blank\" rel=\"noopener\"><span data-contrast=\"none\">Technovigilance<\/span><\/a><span data-contrast=\"none\">.<\/span><span data-ccp-props=\"{&quot;335557856&quot;:16777215,&quot;335559739&quot;:0}\">\u00a0<\/span><\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<ul>\n<li data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"2\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559685&quot;:1080,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;\uf0b7&quot;,&quot;469777815&quot;:&quot;hybridMultilevel&quot;}\" data-aria-posinset=\"1\" data-aria-level=\"1\"><a href=\"https:\/\/vimeo.com\/345391840\" target=\"_blank\" rel=\"noopener\"><span data-contrast=\"none\">Benefits<\/span><\/a><span data-contrast=\"none\"> of having a holder as a commercial partner:<\/span><span data-ccp-props=\"{&quot;335557856&quot;:16777215,&quot;335559739&quot;:0}\">\u00a0<\/span><\/li>\n<\/ul>\n<ul>\n<li style=\"list-style-type: none\">\n<ul>\n<li data-leveltext=\"o\" data-font=\"Courier New\" data-listid=\"2\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559685&quot;:1800,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Courier New&quot;,&quot;469769242&quot;:[9675],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;o&quot;,&quot;469777815&quot;:&quot;hybridMultilevel&quot;}\" data-aria-posinset=\"1\" data-aria-level=\"2\"><span data-contrast=\"none\">To assign or remove local distributors, avoiding dependence on them.<\/span><span data-ccp-props=\"{&quot;335557856&quot;:16777215,&quot;335559739&quot;:0}\">\u00a0<\/span><\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<ul>\n<li style=\"list-style-type: none\">\n<ul>\n<li data-leveltext=\"o\" data-font=\"Courier New\" data-listid=\"2\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559685&quot;:1800,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Courier New&quot;,&quot;469769242&quot;:[9675],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;o&quot;,&quot;469777815&quot;:&quot;hybridMultilevel&quot;}\" data-aria-posinset=\"2\" data-aria-level=\"2\"><span data-contrast=\"none\">Having a local ally, with local presence to oversee your sanitary authorizations.<\/span><span data-ccp-props=\"{&quot;335557856&quot;:16777215,&quot;335559739&quot;:0}\">\u00a0<\/span><\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<p><span data-contrast=\"none\">\u00a0<\/span><span data-ccp-props=\"{&quot;335557856&quot;:16777215,&quot;335559739&quot;:216}\">\u00a0<\/span><\/p>\n<h3><\/h3>\n<h3><b><span data-contrast=\"none\">Post-authorization duties<\/span><\/b><span data-ccp-props=\"{&quot;134245418&quot;:true,&quot;134245529&quot;:true,&quot;335557856&quot;:16777215,&quot;335559738&quot;:120,&quot;335559739&quot;:240}\">\u00a0<\/span><\/h3>\n<p>&nbsp;<\/p>\n<p><span data-contrast=\"none\">When the registration is approved by COFEPRIS, you can sale your medical devices in Mexico. However, it is important to consider that any change in the sanitary registration conditions must be notified through a modification process.<\/span><span data-ccp-props=\"{&quot;335557856&quot;:16777215,&quot;335559739&quot;:216}\">\u00a0<\/span><\/p>\n<p>&nbsp;<\/p>\n<p><span data-contrast=\"none\">On the other hand, the registration is valid for <\/span><a href=\"https:\/\/veraqueconsulting.com\/mx\/changes-on-the-renewal-process-for-medical-device-sanitary-registrations-in-mexico\/\" target=\"_blank\" rel=\"noopener\"><span data-contrast=\"none\">5 years only<\/span><\/a><span data-contrast=\"none\"> and can be renewed for 5 more years.<\/span><span data-ccp-props=\"{&quot;335557856&quot;:16777215,&quot;335559739&quot;:216}\">\u00a0<\/span><\/p>\n<p>&nbsp;<\/p>\n<p><span data-contrast=\"none\">Finally, in case your medical device is related to an <\/span><a href=\"https:\/\/veraqueconsulting.com\/mx\/technovigilance-notifications\/\" target=\"_blank\" rel=\"noopener\"><span data-contrast=\"none\">adverse incident,<\/span><\/a><span data-contrast=\"none\"> your holder must report it to COFEPRIS. <\/span><b><span data-contrast=\"none\">The effective holder\u2019s role in such cases will be determinant for a successful surveillance process.<\/span><\/b><span data-ccp-props=\"{&quot;335557856&quot;:16777215,&quot;335559739&quot;:216}\">\u00a0<\/span><\/p>\n<p><span data-ccp-props=\"{&quot;335557856&quot;:16777215,&quot;335559739&quot;:216}\">\u00a0<\/span><\/p>\n<h3><b><span data-contrast=\"none\">Final Recommendations<\/span><\/b><span data-ccp-props=\"{&quot;335557856&quot;:16777215,&quot;335559739&quot;:216}\">\u00a0<\/span><\/h3>\n<p>&nbsp;<\/p>\n<p><span data-contrast=\"none\">In conclusion, to have a good experience registering a Medical Device in Mexico, we recommend establishing a strategy:<\/span><span data-ccp-props=\"{&quot;335557856&quot;:16777215,&quot;335559739&quot;:216}\">\u00a0<\/span><\/p>\n<ol>\n<li data-leveltext=\"%1.\" data-font=\"Montserrat\" data-listid=\"1\" data-list-defn-props=\"{&quot;335552541&quot;:0,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769242&quot;:[65533,0],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;%1.&quot;,&quot;469777815&quot;:&quot;hybridMultilevel&quot;}\" data-aria-posinset=\"1\" data-aria-level=\"1\"><span data-contrast=\"none\">Start with proper classification. <\/span><span data-ccp-props=\"{&quot;335557856&quot;:16777215,&quot;335559739&quot;:216}\">\u00a0<\/span><\/li>\n<li data-leveltext=\"%1.\" data-font=\"Montserrat\" data-listid=\"1\" data-list-defn-props=\"{&quot;335552541&quot;:0,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769242&quot;:[65533,0],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;%1.&quot;,&quot;469777815&quot;:&quot;hybridMultilevel&quot;}\" data-aria-posinset=\"1\" data-aria-level=\"1\"><span data-contrast=\"none\">Evaluate the most suitable regulatory pathway (standard or equivalency ) <\/span><span data-ccp-props=\"{&quot;335557856&quot;:16777215,&quot;335559739&quot;:216}\">\u00a0<\/span><\/li>\n<li data-leveltext=\"%1.\" data-font=\"Montserrat\" data-listid=\"1\" data-list-defn-props=\"{&quot;335552541&quot;:0,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769242&quot;:[65533,0],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;%1.&quot;,&quot;469777815&quot;:&quot;hybridMultilevel&quot;}\" data-aria-posinset=\"1\" data-aria-level=\"1\"><span data-contrast=\"none\">Consider your post authorization duties.\u00a0<\/span><span data-ccp-props=\"{&quot;335557856&quot;:16777215,&quot;335559739&quot;:216}\">\u00a0<\/span><\/li>\n<\/ol>\n<p><span data-ccp-props=\"{&quot;335557856&quot;:16777215,&quot;335559685&quot;:720,&quot;335559739&quot;:216}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"none\">Our last advice is to carefully choose your <\/span><a href=\"https:\/\/veraqueconsulting.com\/mx\/holding-services\/\" target=\"_blank\" rel=\"noopener\"><span data-contrast=\"none\">Sanitary Registration Holder.<\/span><\/a><span data-contrast=\"none\"> As discussed, this entity plays a major role as your representative in Mexico.<\/span><span data-ccp-props=\"{&quot;335557856&quot;:16777215,&quot;335559739&quot;:216}\">\u00a0<\/span><\/p>\n<p>&nbsp;<\/p>\n<p><strong>For more detailed guidance, refer to our: <\/strong><a href=\"https:\/\/veraqueconsulting.com\/mx\/ultimate-guide-for-regulatory-affairs-in-mexico\/\" target=\"_blank\" rel=\"noopener\"><span data-contrast=\"none\">Ultimate Guide for Regulatory Affairs in Mexico.<\/span><\/a><span data-ccp-props=\"{&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/p>\n<p><span data-ccp-props=\"{&quot;335557856&quot;:16777215,&quot;335559739&quot;:216}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"none\">In case you have any question or comment, please feel free to contact us at <\/span><a href=\"mailto:contact@veraqueconsulting.com\"><span data-contrast=\"none\">contact@veraqueconsulting.com<\/span><\/a><span data-ccp-props=\"{&quot;335557856&quot;:16777215,&quot;335559739&quot;:216}\">\u00a0<\/span><\/p>\n<p><span data-ccp-props=\"{&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/p>\n<p><b><span data-contrast=\"auto\">Updated: February 2026<\/span><\/b><\/p>\n<p><span data-contrast=\"auto\">This brief overview reflects the latest regulatory framework for medical devices in Mexico as of 2026. It will be reviewed as needed to incorporate future updates from COFEPRIS or other relevant authorities.<\/span><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Considering Mexico as the second largest medical device market in Latin America, you may find it as a good alternative to expand your business. Nevertheless, there are a few considerations to register your products in the country. In this overview, we will describe briefly what you need to register your medical device in Mexico and [&hellip;]<\/p>\n","protected":false},"author":2,"featured_media":4067,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[390,19],"tags":[20,21],"class_list":["post-679","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-mexico","category-regulatory-overview","tag-cofepris","tag-medical-devices"],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v28.0 (Yoast SEO v28.0) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>Mexico&#039;s Medical Device Regulatory Overview - Veraque Mexico<\/title>\n<meta name=\"description\" content=\"A brief overview to understand the regulatory process for medical devices in Mexico and some strategies to succeed in this market.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/veraqueconsulting.com\/mx\/medical-device-regulatory-overview-in-mexico-veraque\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Mexico&#039;s Medical Device Regulatory Overview\" \/>\n<meta property=\"og:description\" content=\"A brief overview to understand the regulatory process for medical devices in Mexico and some strategies to succeed in this market.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/veraqueconsulting.com\/mx\/medical-device-regulatory-overview-in-mexico-veraque\/\" \/>\n<meta property=\"og:site_name\" content=\"Veraque Mexico\" \/>\n<meta property=\"article:published_time\" content=\"2020-02-24T14:38:29+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2026-02-09T19:11:10+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/veraqueconsulting.com\/mx\/wp-content\/uploads\/sites\/3\/2020\/02\/mexico_md_regulatory_overview_2025.png\" \/>\n\t<meta property=\"og:image:width\" content=\"940\" \/>\n\t<meta property=\"og:image:height\" content=\"788\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/png\" \/>\n<meta name=\"author\" content=\"Miguel Torres\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"Miguel Torres\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"3 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\\\/\\\/veraqueconsulting.com\\\/mx\\\/medical-device-regulatory-overview-in-mexico-veraque\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/veraqueconsulting.com\\\/mx\\\/medical-device-regulatory-overview-in-mexico-veraque\\\/\"},\"author\":{\"name\":\"Miguel Torres\",\"@id\":\"https:\\\/\\\/veraqueconsulting.com\\\/mx\\\/#\\\/schema\\\/person\\\/3326d3f772dba08fa5303d4e08db5ad0\"},\"headline\":\"Mexico&#8217;s Medical Device Regulatory Overview\",\"datePublished\":\"2020-02-24T14:38:29+00:00\",\"dateModified\":\"2026-02-09T19:11:10+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/veraqueconsulting.com\\\/mx\\\/medical-device-regulatory-overview-in-mexico-veraque\\\/\"},\"wordCount\":536,\"commentCount\":0,\"publisher\":{\"@id\":\"https:\\\/\\\/veraqueconsulting.com\\\/mx\\\/#organization\"},\"image\":{\"@id\":\"https:\\\/\\\/veraqueconsulting.com\\\/mx\\\/medical-device-regulatory-overview-in-mexico-veraque\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/veraqueconsulting.com\\\/mx\\\/wp-content\\\/uploads\\\/sites\\\/3\\\/2020\\\/02\\\/mexico_md_regulatory_overview_2025.png\",\"keywords\":[\"cofepris\",\"medical devices\"],\"articleSection\":[\"Mexico\",\"Regulatory overview\"],\"inLanguage\":\"en-US\",\"potentialAction\":[{\"@type\":\"CommentAction\",\"name\":\"Comment\",\"target\":[\"https:\\\/\\\/veraqueconsulting.com\\\/mx\\\/medical-device-regulatory-overview-in-mexico-veraque\\\/#respond\"]}]},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/veraqueconsulting.com\\\/mx\\\/medical-device-regulatory-overview-in-mexico-veraque\\\/\",\"url\":\"https:\\\/\\\/veraqueconsulting.com\\\/mx\\\/medical-device-regulatory-overview-in-mexico-veraque\\\/\",\"name\":\"Mexico's Medical Device Regulatory Overview - 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