{"id":974,"date":"2020-11-17T18:42:32","date_gmt":"2020-11-17T18:42:32","guid":{"rendered":"https:\/\/veraqueconsulting.com\/mx\/?p=974"},"modified":"2026-05-28T16:22:53","modified_gmt":"2026-05-28T16:22:53","slug":"about-labeling-requirements-for-medical-devices-in-mexico","status":"publish","type":"post","link":"https:\/\/veraqueconsulting.com\/mx\/about-labeling-requirements-for-medical-devices-in-mexico\/","title":{"rendered":"About labeling requirements for medical devices in Mexico"},"content":{"rendered":"

Medical device labeling includes all labels, instructions for use (IFU), and any written, printed, graphical, or electronic information provided by the manufacturer that\u00a0accompanies\u00a0a device.<\/span>\u00a0<\/span><\/p>\n

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Manufacturers worldwide must\u00a0comply with\u00a0both\u00a0<\/span>international standards<\/span><\/a>\u00a0<\/span><\/i>and local regulatory requirements when marketing medical devices. In Mexico, labeling requirements are governed by\u00a0NOM<\/span>\u2011137<\/span>\u2011SSA1<\/span>\u20112025, which introduces a modern, risk-based approach aligned with global regulatory frameworks.<\/span>\u00a0<\/span><\/p>\n

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This article summarizes the current requirements for medical device labeling in Mexico and\u00a0provides\u00a0practical guidance to ensure compliance with COFEPRIS regulations.<\/span>\u00a0<\/span><\/p>\n

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NOM<\/span><\/b>\u2011137<\/span><\/b>\u2011SSA1<\/span><\/b>\u20112008 vs NOM<\/span><\/b>\u2011137<\/span><\/b>\u2011SSA1<\/span><\/b>\u20112025: What Has Changed?<\/span><\/b>\u00a0<\/span><\/h3>\n

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The Mexican regulatory framework for medical device labeling has evolved significantly with the publication of NOM-137-SSA1-2025<\/a><\/span>, which replaces the former NOM-137-SSA1-2008<\/a>.<\/span><\/p>\n

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The 2025 updated standard moves beyond basic compliance and introduces a more sophisticated, risk-oriented, and digitally enabled approach aligned with international standards such as ISO and IMDRF principles.<\/span>\u00a0<\/span><\/p>\n

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Key Changes in NOM-137-SSA1-2025<\/a>\u00a0<\/strong><\/h5>\n

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    Risk-Based, Safety-Oriented Labeling<\/strong><\/h5>\n<\/li>\n<\/ol>\n

    Labeling must\u00a0now\u00a0be developed under a risk management approach, integrating intended use, residual risks, contraindications, and key safety and performance information to ensure safe\u00a0and effective\u00a0use across the device lifecycle.<\/span>\u00a0<\/span><\/p>\n

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      Integration of Tecnovigilance Requirements\u00a0<\/strong><\/h5>\n

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      Labeling must include clear instructions on reporting incidents or adverse events, specifying the\u00a0appropriate responsible\u00a0party and competent authority, thereby strengthening\u00a0<\/span>post-market surveillance.<\/span><\/a>\u00a0<\/span><\/p>\n

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        Joint Responsibility of Manufacturer and Registration Holder<\/strong><\/h5>\n<\/li>\n<\/ol>\n

        The standard recognizes that the manufacturer and the registration holder might\u00a0be\u00a0different entities and confirms that both\u00a0are responsible for\u00a0the sanitary information included in labeling.<\/span>\u00a0<\/span><\/p>\n

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        In practice, original labeling is rarely sufficient to meet Mexican requirements. This makes close coordination essential, particularly when compliance requires supplementary back or counter-labeling.<\/span>\u00a0<\/span><\/p>\n

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          Expanded Scope and Electronic Labeling (Label and IFU)<\/strong><\/h5>\n<\/li>\n<\/ol>\n

          \u201cLabeling\u201d now explicitly includes the label, IFU, manuals, and other manufacturer-provided information. The 2025 version\u00a0establishes\u00a0clearer and more precise requirements for both the label and IFU.<\/span>\u00a0<\/span><\/p>\n

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          In addition, the new standard formally recognizes electronic formats\u00a0(such as QR codes, RFID, websites, and\u00a0eIFU)\u00a0as valid means of delivering labeling information.\u00a0<\/span>\u00a0<\/span><\/p>\n

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            New categories covered<\/strong><\/h5>\n<\/li>\n<\/ol>\n