{"id":4235,"date":"2026-02-17T20:24:10","date_gmt":"2026-02-17T20:24:10","guid":{"rendered":"https:\/\/veraqueconsulting.com\/mx\/?p=4235"},"modified":"2026-02-17T20:24:10","modified_gmt":"2026-02-17T20:24:10","slug":"combination-products-medicinal-products-and-medical-devices-in-mexico","status":"publish","type":"post","link":"https:\/\/veraqueconsulting.com\/mx\/combination-products-medicinal-products-and-medical-devices-in-mexico\/","title":{"rendered":"Combination Products: Medicinal Products and Medical Devices in Mexico"},"content":{"rendered":"<p><span data-contrast=\"auto\">Combination products,\u00a0those integrating a medicinal substance with a medical device,\u00a0are increasingly relevant in modern healthcare. These products enable targeted delivery, improve patient adherence, and\u00a0optimize\u00a0therapeutic outcomes. This article provides an overview of combination products, their classification, and regulatory considerations under Mexican standards.<\/span><span data-ccp-props=\"{}\">\u00a0<\/span><\/p>\n<p><span data-ccp-props=\"{}\">\u00a0<\/span><\/p>\n<p><span data-ccp-props=\"{}\">\u00a0<\/span><\/p>\n<h3><b><span data-contrast=\"auto\">What Are Combination Products?<\/span><\/b><span data-ccp-props=\"{}\">\u00a0<\/span><\/h3>\n<p><span data-ccp-props=\"{}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">Combination products are defined as healthcare products that incorporate both a pharmaceutical\u00a0component\u00a0(active ingredient or drug) and a medical device (delivery system or application mechanism).\u00a0<\/span><span data-ccp-props=\"{}\">\u00a0<\/span><\/p>\n<p><span data-ccp-props=\"{}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">Common\u00a0examples\u00a0include:<\/span><span data-ccp-props=\"{}\">\u00a0<\/span><\/p>\n<ul>\n<li data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"2\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559685&quot;:720,&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;multilevel&quot;}\" data-aria-posinset=\"1\" data-aria-level=\"1\"><span data-contrast=\"auto\">Pre-filled syringes and pens for injectable medications<\/span><span data-ccp-props=\"{}\">\u00a0<\/span><\/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;:720,&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;multilevel&quot;}\" data-aria-posinset=\"2\" data-aria-level=\"1\"><span data-contrast=\"auto\">Drug-eluting stents used in cardiovascular interventions<\/span><span data-ccp-props=\"{}\">\u00a0<\/span><\/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;:720,&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;multilevel&quot;}\" data-aria-posinset=\"3\" data-aria-level=\"1\"><span data-contrast=\"auto\">Inhalers combining bronchodilators or corticosteroids with a device for pulmonary administration<\/span><span data-ccp-props=\"{}\">\u00a0<\/span><\/li>\n<\/ul>\n<p><span data-ccp-props=\"{&quot;335559685&quot;:720}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">These products are designed to deliver medication through a controlled mechanism, ensuring\u00a0accurate\u00a0dosing and improved safety.<\/span><span data-ccp-props=\"{}\">\u00a0<\/span><\/p>\n<p><span data-ccp-props=\"{}\">\u00a0<\/span><\/p>\n<h3><b><span data-contrast=\"auto\">Regulatory Classification in Mexico<\/span><\/b><span data-ccp-props=\"{}\">\u00a0<\/span><\/h3>\n<p><span data-ccp-props=\"{}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">Under Mexican regulation, classification depends on the primary mode of action. However, when a medical device incorporates a drug as an integral part, the regulatory framework is clear:<\/span><span data-ccp-props=\"{}\"><\/p>\n<p><\/span><\/p>\n<p style=\"text-align: right\"><i><span data-contrast=\"auto\">Medical devices that incorporate a drug or medication are those that include, as an integral part, a drug or medication that exerts on the human\u00a0body\u00a0a secondary or\u00a0additional\u00a0action to that of the medical device.<\/span><\/i><span data-contrast=\"auto\">\u00a0<\/span><span data-ccp-props=\"{&quot;335551550&quot;:3,&quot;335551620&quot;:3}\">\u00a0<\/span><\/p>\n<p><span data-ccp-props=\"{}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">According to the\u00a0<\/span><a href=\"https:\/\/veraqueconsulting.com\/mx\/medical-device-supplement-from-the-mexican-pharmacopoeia\/\"><span data-contrast=\"none\">Medical Device Supplement from the Mexican Pharmacopoeia<\/span><\/a><span data-contrast=\"auto\">, these products are classified as Class III medical devices, given their complexity and risk profile:<\/span><span data-ccp-props=\"{}\">\u00a0<\/span><\/p>\n<p><span data-ccp-props=\"{}\">\u00a0<\/span><\/p>\n<p style=\"text-align: right\"><i><span data-contrast=\"auto\">All medical devices that incorporate, as an integral part, a substance that when used separately is considered a medicine [\u2026] will belong to Class III.<\/span><\/i><span data-contrast=\"auto\">\u00a0<\/span><span data-ccp-props=\"{&quot;335551550&quot;:3,&quot;335551620&quot;:3}\">\u00a0<\/span><\/p>\n<p><span data-ccp-props=\"{}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">This classification entails rigorous safety, efficacy, and quality requirements, including the evaluation of both the device and the medicinal\u00a0component. It is also important to note that registering combination products in Mexico is inherently more complex, as regulatory submission must include complete technical and legal documentation from both the drug manufacturer and the medical device manufacturer.<\/span><span data-ccp-props=\"{}\">\u00a0<\/span><\/p>\n<p><span data-ccp-props=\"{}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">In addition, these products must account for characteristics that can directly affect the medicinal substance (such as packaging interactions with light, humidity, and other environmental factors) making their assessment and approval more demanding.<\/span><span data-ccp-props=\"{}\">\u00a0<\/span><\/p>\n<p><span data-ccp-props=\"{}\">\u00a0<\/span><\/p>\n<p><span data-ccp-props=\"{}\">\u00a0<\/span><\/p>\n<h3><b><span data-contrast=\"auto\">Registration Pathways and Grouping Criteria<\/span><\/b><span data-ccp-props=\"{}\">\u00a0<\/span><\/h3>\n<p><span data-ccp-props=\"{}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">For manufacturers seeking registration in Mexico, the following considerations apply:<\/span><span data-ccp-props=\"{}\"><\/p>\n<p><\/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;:720,&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;multilevel&quot;}\" data-aria-posinset=\"1\" data-aria-level=\"1\"><b><span data-contrast=\"auto\">Single Registration:<\/span><\/b><span data-contrast=\"auto\">\u00a0Combination products are\u00a0generally registered\u00a0under one sanitary registration, provided they are marketed as a unified system.<\/span><span data-ccp-props=\"{}\">\u00a0<\/span><\/li>\n<\/ul>\n<p><span data-ccp-props=\"{&quot;335559685&quot;:720}\">\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;:720,&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;multilevel&quot;}\" data-aria-posinset=\"2\" data-aria-level=\"1\"><b><span data-contrast=\"auto\">Grouping:<\/span><\/b><span data-contrast=\"auto\">\u00a0Multiple presentations (e.g., different dosages or device sizes) may be grouped if they share:<\/span><span data-ccp-props=\"{}\">\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;:1440,&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;multilevel&quot;}\" data-aria-posinset=\"1\" data-aria-level=\"2\"><span data-contrast=\"auto\">Same\u00a0manufacturer<\/span><span data-ccp-props=\"{}\">\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;:1440,&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;multilevel&quot;}\" data-aria-posinset=\"2\" data-aria-level=\"2\"><span data-contrast=\"auto\">Same\u00a0commercial\u00a0name<\/span><span data-ccp-props=\"{}\">\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;:1440,&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;multilevel&quot;}\" data-aria-posinset=\"3\" data-aria-level=\"2\"><span data-contrast=\"auto\">Same\u00a0intended\u00a0use<\/span><span data-ccp-props=\"{}\">\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;:1440,&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;multilevel&quot;}\" data-aria-posinset=\"4\" data-aria-level=\"2\"><span data-contrast=\"auto\">Same\u00a0technology\u00a0platform<\/span><span data-ccp-props=\"{}\">\n<p><\/span><\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<p><span data-contrast=\"auto\">Additional\u00a0documentation is\u00a0required\u00a0to\u00a0demonstrate\u00a0compatibility and safety of both components.<\/span><span data-ccp-props=\"{}\">\u00a0<\/span><\/p>\n<p><span data-ccp-props=\"{}\">\u00a0<\/span><\/p>\n<h3><b><span data-contrast=\"auto\">Frequently Asked Questions (FAQ)<\/span><\/b><span data-ccp-props=\"{}\">\u00a0<\/span><\/h3>\n<p>&nbsp;<\/p>\n<ol>\n<li><span data-contrast=\"auto\"> What are combination products in healthcare?<\/span><\/li>\n<\/ol>\n<p><span data-contrast=\"auto\">Combination products are medical technologies that integrate a medicinal product and a medical device into a single system. Examples include drug-eluting stents, pre-filled syringes, and inhalers with medication delivery mechanisms. These products are designed to improve therapeutic outcomes by combining controlled drug administration with device functionality.<\/span><span data-ccp-props=\"{}\">\u00a0<\/span><\/p>\n<p><span data-ccp-props=\"{}\">\u00a0<\/span><\/p>\n<ol start=\"2\">\n<li><span data-contrast=\"auto\"> How are combination products classified under Mexican regulations?<\/span><\/li>\n<\/ol>\n<p><span data-contrast=\"auto\">According to COFEPRIS and the\u00a0<\/span><a href=\"https:\/\/veraqueconsulting.com\/mx\/medical-device-supplement-from-the-mexican-pharmacopoeia\/\"><span data-contrast=\"none\">FEUM\u00a0Supplement<\/span><\/a><span data-contrast=\"auto\">, combination products where a device incorporates a drug as an integral part are classified as Class III medical devices.\u00a0<\/span><span data-ccp-props=\"{}\">\u00a0<\/span><\/p>\n<p><span data-ccp-props=\"{}\">\u00a0<\/span><\/p>\n<ol start=\"3\">\n<li><span data-contrast=\"auto\"> Why is the regulatory submission for combination products more complex in Mexico?<\/span><\/li>\n<\/ol>\n<p><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;201341983&quot;:0,&quot;335551550&quot;:0,&quot;335551620&quot;:0,&quot;335559738&quot;:0,&quot;335559739&quot;:0,&quot;335559740&quot;:300}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">Regulatory submission for combination products in Mexico is more complex because authorities must evaluate both components of the product\u2014the medical device and the medicinal substance. This requires complete technical and legal documentation from both the device manufacturer and the drug manufacturer, ensuring that each part meets its respective regulatory standards.\u00a0<\/span><span data-contrast=\"auto\">As a result, the approval pathway is more rigorous than for standalone devices or medications.<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;201341983&quot;:0,&quot;335551550&quot;:0,&quot;335551620&quot;:0,&quot;335559738&quot;:0,&quot;335559739&quot;:0,&quot;335559740&quot;:300}\">\u00a0<\/span><\/p>\n<p><span data-ccp-props=\"{}\">\u00a0<\/span><\/p>\n<h3><span data-contrast=\"auto\">\u00a0<\/span><b><span data-contrast=\"auto\">Conclusion<\/span><\/b><span data-ccp-props=\"{}\">\u00a0<\/span><\/h3>\n<p><span data-contrast=\"auto\"><br \/>\nCombination products are among the most complex categories regulated in Mexico because they integrate a medical device and a medicinal substance, requiring full technical and legal documentation from both manufacturers. This dual\u2011compliance obligation makes their registration far more demanding than standard submissions.<\/span><span data-ccp-props=\"{}\">\u00a0<\/span><\/p>\n<p><span data-ccp-props=\"{}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">In this complex environment, expert guidance is highly valuable.\u00a0<\/span><a href=\"mailto:contact@veraqueconsulting.com\"><b><span data-contrast=\"none\">Partner with\u00a0Veraque<\/span><\/b><\/a><b><span data-contrast=\"auto\">\u00a0<\/span><\/b><span data-contrast=\"auto\">for clear, tailored guidance through Mexico\u2019s regulatory landscape.<\/span><span data-ccp-props=\"{}\">\u00a0<\/span><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Combination products,\u00a0those integrating a medicinal substance with a medical device,\u00a0are increasingly relevant in modern healthcare. These products enable targeted delivery, improve patient adherence, and\u00a0optimize\u00a0therapeutic outcomes. This article provides an overview of combination products, their classification, and regulatory considerations under Mexican standards.\u00a0 \u00a0 \u00a0 What Are Combination Products?\u00a0 \u00a0 Combination products are defined as healthcare products [&hellip;]<\/p>\n","protected":false},"author":6,"featured_media":4236,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[367,390],"tags":[],"class_list":["post-4235","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-classification","category-mexico"],"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>Combination Products: Regulation in Mexico - Veraque Mexico<\/title>\n<meta name=\"description\" content=\"Discover how combination products are regulated and classified in Mexico under COFEPRIS, including key guidelines for device\u2013drug systems.\" \/>\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\/combination-products-medicinal-products-and-medical-devices-in-mexico\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Combination Products: Medicinal Products and Medical Devices in Mexico\" \/>\n<meta property=\"og:description\" content=\"Discover how combination products are regulated and classified in Mexico under COFEPRIS, including key guidelines for device\u2013drug systems.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/veraqueconsulting.com\/mx\/combination-products-medicinal-products-and-medical-devices-in-mexico\/\" \/>\n<meta property=\"og:site_name\" content=\"Veraque Mexico\" \/>\n<meta property=\"article:published_time\" content=\"2026-02-17T20:24:10+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/veraqueconsulting.com\/mx\/wp-content\/uploads\/sites\/3\/2026\/02\/classification_combination_products_mexico.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=\"mkt1\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"mkt1\" \/>\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\\\/combination-products-medicinal-products-and-medical-devices-in-mexico\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/veraqueconsulting.com\\\/mx\\\/combination-products-medicinal-products-and-medical-devices-in-mexico\\\/\"},\"author\":{\"name\":\"mkt1\",\"@id\":\"https:\\\/\\\/veraqueconsulting.com\\\/mx\\\/#\\\/schema\\\/person\\\/3f760cd8f7128ca81c70930dcfcc1e44\"},\"headline\":\"Combination Products: Medicinal Products and Medical Devices in Mexico\",\"datePublished\":\"2026-02-17T20:24:10+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/veraqueconsulting.com\\\/mx\\\/combination-products-medicinal-products-and-medical-devices-in-mexico\\\/\"},\"wordCount\":642,\"publisher\":{\"@id\":\"https:\\\/\\\/veraqueconsulting.com\\\/mx\\\/#organization\"},\"image\":{\"@id\":\"https:\\\/\\\/veraqueconsulting.com\\\/mx\\\/combination-products-medicinal-products-and-medical-devices-in-mexico\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/veraqueconsulting.com\\\/mx\\\/wp-content\\\/uploads\\\/sites\\\/3\\\/2026\\\/02\\\/classification_combination_products_mexico.png\",\"articleSection\":[\"classification\",\"Mexico\"],\"inLanguage\":\"en-US\"},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/veraqueconsulting.com\\\/mx\\\/combination-products-medicinal-products-and-medical-devices-in-mexico\\\/\",\"url\":\"https:\\\/\\\/veraqueconsulting.com\\\/mx\\\/combination-products-medicinal-products-and-medical-devices-in-mexico\\\/\",\"name\":\"Combination Products: Regulation in Mexico - 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