{"id":4432,"date":"2026-09-08T22:08:46","date_gmt":"2026-09-08T22:08:46","guid":{"rendered":"https:\/\/veraqueconsulting.com\/mx\/?p=4432"},"modified":"2026-09-08T22:08:46","modified_gmt":"2026-09-08T22:08:46","slug":"label-design-in-mexico-what-it-is-and-what-it-is-not","status":"publish","type":"post","link":"https:\/\/veraqueconsulting.com\/mx\/label-design-in-mexico-what-it-is-and-what-it-is-not\/","title":{"rendered":"Label Design in Mexico: What It Is and What It Is Not"},"content":{"rendered":"<p><span data-contrast=\"auto\">When preparing a medical device sanitary registration dossier in Mexico, one of the mandatory documents requested by COFEPRIS is the label design.<\/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<p><span data-contrast=\"auto\">Although the term is widely used within the Mexican regulatory environment, it is often misunderstood. Many assume that a label design is simply a draft version of the final commercial label that will be printed and placed on the product.\u00a0In reality, its\u00a0regulatory purpose is\u00a0very different.<\/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<p><span data-contrast=\"auto\">Understanding the role of the label design is essential not only for obtaining a sanitary registration, but also for ensuring that the information provided to COFEPRIS accurately reflects the labeling that will\u00a0accompany\u00a0the device once commercialized in Mexico.<\/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><b><span data-contrast=\"auto\">What Is a Label Design?<\/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=\"auto\">A label design is a regulatory document\u00a0submitted\u00a0as part of a sanitary registration application\u00a0that compiles all labeling information\u00a0required\u00a0for a medical device in Mexico.<\/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=\"auto\">Under the Mexican regulatory framework, labeling compliance is assessed against the requirements\u00a0established\u00a0in\u00a0<\/span><a href=\"https:\/\/veraqueconsulting.com\/mx\/about-labeling-requirements-for-medical-devices-in-mexico\/\" target=\"_blank\" rel=\"noopener\"><span data-contrast=\"none\">NOM-137-SSA1-2025<\/span><\/a><span data-contrast=\"auto\">, which defines the information that must be made available to users and healthcare professionals throughout the labeling system.\u00a0<\/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=\"auto\">In practical terms, the label design is usually generated from two primary sources:<\/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=\"19\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559683&quot;:0,&quot;335559684&quot;:-2,&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;hybridMultilevel&quot;}\" data-aria-posinset=\"1\" data-aria-level=\"1\"><span data-contrast=\"auto\">The manufacturer&#8217;s original label.<\/span><span data-ccp-props=\"{&quot;335557856&quot;:16777215,&quot;335559739&quot;:216}\">\u00a0<\/span><\/li>\n<\/ul>\n<ul>\n<li data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"19\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559683&quot;:0,&quot;335559684&quot;:-2,&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;hybridMultilevel&quot;}\" data-aria-posinset=\"2\" data-aria-level=\"1\"><span data-contrast=\"auto\">The\u00a0additional\u00a0information required by NOM-137-SSA1.<\/span><span data-ccp-props=\"{&quot;335557856&quot;:16777215,&quot;335559739&quot;:216}\">\u00a0<\/span><\/li>\n<\/ul>\n<p><span data-ccp-props=\"{&quot;335557856&quot;:16777215,&quot;335559739&quot;:216}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">The resulting document becomes a comprehensive regulatory reference that\u00a0demonstrates\u00a0how the device labeling will\u00a0comply with\u00a0Mexican requirements.<\/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><b><span data-contrast=\"auto\">The Label Design as a Regulatory Guide<\/span><\/b><span data-ccp-props=\"{&quot;335557856&quot;:16777215,&quot;335559739&quot;:216}\">\u00a0<\/span><\/h3>\n<p><span data-ccp-props=\"{&quot;335557856&quot;:16777215,&quot;335559739&quot;:216}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">One of the most important concepts to understand is that the label design\u00a0represents\u00a0the complete labeling framework\u00a0expected for the Mexican market.<\/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<p><span data-contrast=\"auto\">The original manufacturer label is only one\u00a0component\u00a0of that framework. In many cases, the original labeling does not\u00a0contain\u00a0all information required by Mexican regulations. As a result,\u00a0additional\u00a0information must be incorporated through a counter-label, over-label, back-label, or secondary label, as\u00a0permitted\u00a0by Mexican regulations. This concept has been previously discussed in\u00a0<\/span><a href=\"https:\/\/veraqueconsulting.com\/mx\/about-labeling-requirements-for-medical-devices-in-mexico\/\" target=\"_blank\" rel=\"noopener\"><span data-contrast=\"none\">our article about medical device labeling requirements in Mexico.<\/span><\/a><span data-contrast=\"auto\">\u00a0<\/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<p><span data-contrast=\"auto\">For this reason, the label design serves as a practical tool to:<\/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=\"20\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559683&quot;:0,&quot;335559684&quot;:-2,&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;hybridMultilevel&quot;}\" data-aria-posinset=\"1\" data-aria-level=\"1\"><span data-contrast=\"auto\">Identify\u00a0missing regulatory information.<\/span><span data-ccp-props=\"{&quot;335557856&quot;:16777215,&quot;335559739&quot;:216}\">\u00a0<\/span><\/li>\n<\/ul>\n<ul>\n<li data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"20\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559683&quot;:0,&quot;335559684&quot;:-2,&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;hybridMultilevel&quot;}\" data-aria-posinset=\"2\" data-aria-level=\"1\"><span data-contrast=\"auto\">Determine\u00a0whether a counter-label will be\u00a0required.<\/span><span data-ccp-props=\"{&quot;335557856&quot;:16777215,&quot;335559739&quot;:216}\">\u00a0<\/span><\/li>\n<\/ul>\n<ul>\n<li data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"20\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559683&quot;:0,&quot;335559684&quot;:-2,&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;hybridMultilevel&quot;}\" data-aria-posinset=\"3\" data-aria-level=\"1\"><span data-contrast=\"auto\">Verify consistency among labeling, technical documentation, and\u00a0the\u00a0sanitary\u00a0registration\u00a0application.<\/span><span data-ccp-props=\"{&quot;335557856&quot;:16777215,&quot;335559739&quot;:216}\">\u00a0<\/span><\/li>\n<\/ul>\n<ul>\n<li data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"20\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559683&quot;:0,&quot;335559684&quot;:-2,&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;hybridMultilevel&quot;}\" data-aria-posinset=\"4\" data-aria-level=\"1\"><span data-contrast=\"auto\">Establish the content that must\u00a0ultimately be\u00a0available to the user.<\/span><span data-ccp-props=\"{&quot;335557856&quot;:16777215,&quot;335559739&quot;:216}\">\u00a0<\/span><\/li>\n<\/ul>\n<p><span data-ccp-props=\"{&quot;335557856&quot;:16777215,&quot;335559739&quot;:216}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">In other words, the label design functions as a roadmap for achieving labeling compliance rather than as a commercial artwork.<\/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><b><span data-contrast=\"auto\">Why Is the Label Design Important for COFEPRIS?<\/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=\"auto\">Beyond being a submission requirement, the label design plays\u00a0an important role\u00a0during the regulatory review process.<\/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<p><span data-contrast=\"auto\">COFEPRIS evaluates not only the technical characteristics of a medical device but also whether users will receive the information necessary for its safe and effective use. According to NOM-137-SSA1-2025, labeling is part of the overall safety and performance strategy of a medical device and must include information such as intended use, warnings, precautions, traceability elements, and other safety-related content when applicable.\u00a0<\/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<p><span data-contrast=\"auto\">The label design therefore acts as a formal notification to COFEPRIS\u00a0regarding\u00a0the information that will\u00a0accompany\u00a0the product once it reaches the Mexican market. The authority relies on this information when assessing whether the device can be used safely under the proposed conditions of use.<\/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<p><span data-contrast=\"auto\">For this reason, omissions or inconsistencies in the label design\u00a0frequently\u00a0generate questions during the review process and may affect approval timelines.<\/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><b><span data-contrast=\"auto\">What a Label Design Is Not<\/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=\"auto\">A common misconception is that the label design must look exactly like the final label that will be printed on the product packaging.<\/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=\"auto\">This is not its purpose.<\/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=\"auto\">A label design is not intended to be a production-ready artwork. In many cases, it\u00a0contains\u00a0information that would not be practical to display in a final packaging layout, such as\u00a0lists of multiple product codes included in\u00a0a registration, alternative presentations\u00a0etcetera.\u00a0<\/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=\"auto\">Similarly, the label design should not be interpreted as a requirement to completely redesign the manufacturer&#8217;s original label.<\/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=\"auto\">Mexican regulations recognize the value of the original labeling and allow manufacturers to supplement missing information through compliant secondary labeling when necessary.\u00a0<\/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<p><span data-contrast=\"auto\">Therefore, the\u00a0objective\u00a0is\u00a0generally not\u00a0to replace the original label but to\u00a0demonstrate\u00a0how the complete set of required information will be made available to the end user.<\/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><b><span data-contrast=\"auto\">Relationship Between the Original Label, the Counter-Label, and the Label Design<\/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=\"auto\">A useful way to visualize these concepts is as follows:<\/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=\"21\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559683&quot;:0,&quot;335559684&quot;:-2,&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;hybridMultilevel&quot;}\" data-aria-posinset=\"1\" data-aria-level=\"1\"><span data-contrast=\"auto\">Original label:\u00a0Information already provided by the manufacturer.<\/span><span data-ccp-props=\"{&quot;335557856&quot;:16777215,&quot;335559739&quot;:216}\">\u00a0<\/span><\/li>\n<\/ul>\n<ul>\n<li data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"21\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559683&quot;:0,&quot;335559684&quot;:-2,&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;hybridMultilevel&quot;}\" data-aria-posinset=\"2\" data-aria-level=\"1\"><span data-contrast=\"auto\">Counter-label:\u00a0Information added to satisfy Mexican regulatory requirements when the original label is incomplete.<\/span><span data-ccp-props=\"{&quot;335557856&quot;:16777215,&quot;335559739&quot;:216}\">\u00a0<\/span><\/li>\n<\/ul>\n<ul>\n<li data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"21\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559683&quot;:0,&quot;335559684&quot;:-2,&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;hybridMultilevel&quot;}\" data-aria-posinset=\"3\" data-aria-level=\"1\"><span data-contrast=\"auto\">Label design:\u00a0The complete regulatory picture showing all information that must be available for compliance.<\/span><span data-ccp-props=\"{&quot;335557856&quot;:16777215,&quot;335559739&quot;:216}\">\u00a0<\/span><\/li>\n<\/ul>\n<p><span data-ccp-props=\"{&quot;335557856&quot;:16777215,&quot;335559739&quot;:216}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">The label design\u00a0consolidates\u00a0both sources of information and allows regulators and registration holders to\u00a0identify\u00a0any potential gaps before commercialization.<\/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<p><span data-contrast=\"auto\">As a result, it becomes one of the most valuable tools for preventing labeling deficiencies and ensuring alignment between the sanitary registration, labeling documentation, and the final marketed device.<\/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><b><span data-contrast=\"auto\">Frequently Asked Questions (FAQ):\u00a0Label Design\u00a0in Mexico<\/span><\/b><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;201341983&quot;:0,&quot;335551550&quot;:1,&quot;335551620&quot;:1,&quot;335557856&quot;:16777215,&quot;335559685&quot;:0,&quot;335559737&quot;:0,&quot;335559738&quot;:0,&quot;335559739&quot;:216,&quot;335559740&quot;:300}\">\u00a0<\/span><\/h3>\n<p>&nbsp;<\/p>\n<ol>\n<li><b><span data-contrast=\"auto\"> Do I need to redesign my global label specifically for Mexico?<\/span><\/b><\/li>\n<\/ol>\n<p><span data-contrast=\"auto\">Not necessarily. Mexican regulations\u00a0generally consider\u00a0the manufacturer&#8217;s original label as part of the overall labeling system. If certain required information is missing, it can often be added through a compliant counter-label rather than completely redesigning the global artwork.<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559739&quot;:0,&quot;335559740&quot;:300}\">\u00a0<\/span><\/p>\n<p><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559739&quot;:0,&quot;335559740&quot;:300}\">\u00a0<\/span><\/p>\n<ol start=\"2\">\n<li><b><span data-contrast=\"none\"> Why does COFEPRIS require a label design during the registration process?<\/span><\/b><span data-ccp-props=\"{&quot;335557856&quot;:16777215,&quot;335559739&quot;:216}\">\u00a0<\/span><\/li>\n<\/ol>\n<p><span data-contrast=\"none\">The label design allows COFEPRIS to evaluate whether the information that will\u00a0accompany\u00a0the medical device is sufficient for its safe and effective use. It serves as a formal representation of the labeling content that will be available in the Mexican market and helps the authority assess compliance with applicable labeling requirements before granting the sanitary registration.<\/span><span data-ccp-props=\"{&quot;335557856&quot;:16777215,&quot;335559739&quot;:216}\">\u00a0<\/span><\/p>\n<p><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559739&quot;:0,&quot;335559740&quot;:300}\">\u00a0<\/span><\/p>\n<ol start=\"3\">\n<li><b><span data-contrast=\"auto\">Is a label design the same as the final label that will be printed on the product?<\/span><\/b><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559739&quot;:0,&quot;335559740&quot;:300}\">\u00a0<\/span><\/li>\n<\/ol>\n<p><span data-contrast=\"auto\">No. A label design is a regulatory document prepared for the sanitary registration process, not a production-ready artwork. Its purpose is to\u00a0demonstrate\u00a0compliance with Mexican labeling requirements and to show COFEPRIS all labeling information that will be available to the user.<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559739&quot;:0,&quot;335559740&quot;:300}\">\u00a0<\/span><\/p>\n<p><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559739&quot;:0,&quot;335559740&quot;:300}\">\u00a0<\/span><\/p>\n<h3><b><span data-contrast=\"auto\">Conclusions<\/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=\"auto\">The term label design should not be confused with a commercial packaging draft or final artwork.\u00a0In Mexico, the label design is a mandatory regulatory document used during sanitary registration applications to\u00a0demonstrate\u00a0compliance with labeling requirements\u00a0established\u00a0by NOM-137-SSA1. It is built from the manufacturer&#8217;s original labeling together with any\u00a0additional\u00a0information required by Mexican regulations.<\/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<p><span data-contrast=\"auto\">Most importantly, the label design serves as a regulatory guide for manufacturers, registration holders, and COFEPRIS reviewers. It helps\u00a0identify\u00a0missing information, supports the development of compliant counter-labels when necessary, and communicates to the authority the labeling information that will be provided to users once the device is commercialized in Mexico.<\/span><\/p>\n<p><span data-contrast=\"auto\"><br \/>\n<a class=\"Hyperlink SCXW54475103 BCX0\" href=\"mailto:contact@veraqueconsulting.com\" target=\"_blank\" rel=\"noreferrer noopener\"><span class=\"TextRun Underlined SCXW54475103 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"none\"><span class=\"NormalTextRun SCXW54475103 BCX0\" data-ccp-charstyle=\"Hyperlink\">Rely on<\/span><span class=\"NormalTextRun SCXW54475103 BCX0\" data-ccp-charstyle=\"Hyperlink\">\u00a0<\/span><span class=\"NormalTextRun SCXW54475103 BCX0\" data-ccp-charstyle=\"Hyperlink\">Veraque<\/span><span class=\"NormalTextRun SCXW54475103 BCX0\" data-ccp-charstyle=\"Hyperlink\">\u00a0as your p<\/span><span class=\"NormalTextRun SCXW54475103 BCX0\" data-ccp-charstyle=\"Hyperlink\">a<\/span><span class=\"NormalTextRun SCXW54475103 BCX0\" data-ccp-charstyle=\"Hyperlink\">rtner<\/span><\/span><\/a><span class=\"TextRun SCXW54475103 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW54475103 BCX0\">\u00a0for navigating medical device labeling and sanitary registration in Mexico.<\/span><\/span><span class=\"TextRun SCXW54475103 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW54475103 BCX0\">\u00a0With more than 15 years of experience supporting international manufacturers, we deliver expert guidance to ensure compliance and efficiency.\u00a0<\/span><\/span><span class=\"EOP Selected SCXW54475103 BCX0\" data-ccp-props=\"{&quot;335557856&quot;:16777215,&quot;335559739&quot;:216}\">\u00a0<\/span><br \/>\n<\/span><\/p>\n","protected":false},"excerpt":{"rendered":"<p>When preparing a medical device sanitary registration dossier in Mexico, one of the mandatory documents requested by COFEPRIS is the label design.\u00a0 \u00a0 Although the term is widely used within the Mexican regulatory environment, it is often misunderstood. Many assume that a label design is simply a draft version of the final commercial label that [&hellip;]<\/p>\n","protected":false},"author":6,"featured_media":4433,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[381,390],"tags":[],"class_list":["post-4432","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-cofepris","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>Label Design in Mexico: What It Is and What It Is Not - Veraque Mexico<\/title>\n<meta name=\"description\" content=\"Understand the purpose of a label design in Mexico, its role in COFEPRIS registrations, and common misconceptions about labeling compliance.\" \/>\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\/label-design-in-mexico-what-it-is-and-what-it-is-not\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Label Design in Mexico: What It Is and What It Is Not\" \/>\n<meta property=\"og:description\" content=\"Understand the purpose of a label design in Mexico, its role in COFEPRIS registrations, and common misconceptions about labeling compliance.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/veraqueconsulting.com\/mx\/label-design-in-mexico-what-it-is-and-what-it-is-not\/\" \/>\n<meta property=\"og:site_name\" content=\"Veraque Mexico\" \/>\n<meta property=\"article:published_time\" content=\"2026-09-08T22:08:46+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/veraqueconsulting.com\/mx\/wp-content\/uploads\/sites\/3\/2026\/09\/labeling_medical_device.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=\"6 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\\\/\\\/veraqueconsulting.com\\\/mx\\\/label-design-in-mexico-what-it-is-and-what-it-is-not\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/veraqueconsulting.com\\\/mx\\\/label-design-in-mexico-what-it-is-and-what-it-is-not\\\/\"},\"author\":{\"name\":\"mkt1\",\"@id\":\"https:\\\/\\\/veraqueconsulting.com\\\/mx\\\/#\\\/schema\\\/person\\\/3f760cd8f7128ca81c70930dcfcc1e44\"},\"headline\":\"Label Design in Mexico: What It Is and What It Is Not\",\"datePublished\":\"2026-09-08T22:08:46+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/veraqueconsulting.com\\\/mx\\\/label-design-in-mexico-what-it-is-and-what-it-is-not\\\/\"},\"wordCount\":1146,\"publisher\":{\"@id\":\"https:\\\/\\\/veraqueconsulting.com\\\/mx\\\/#organization\"},\"image\":{\"@id\":\"https:\\\/\\\/veraqueconsulting.com\\\/mx\\\/label-design-in-mexico-what-it-is-and-what-it-is-not\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/veraqueconsulting.com\\\/mx\\\/wp-content\\\/uploads\\\/sites\\\/3\\\/2026\\\/09\\\/labeling_medical_device.png\",\"articleSection\":[\"COFEPRIS\",\"Mexico\"],\"inLanguage\":\"en-US\"},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/veraqueconsulting.com\\\/mx\\\/label-design-in-mexico-what-it-is-and-what-it-is-not\\\/\",\"url\":\"https:\\\/\\\/veraqueconsulting.com\\\/mx\\\/label-design-in-mexico-what-it-is-and-what-it-is-not\\\/\",\"name\":\"Label Design in Mexico: What It Is and What It Is Not - 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