{"id":3977,"date":"2025-06-10T21:41:01","date_gmt":"2025-06-10T21:41:01","guid":{"rendered":"https:\/\/veraqueconsulting.com\/mx\/?p=3977"},"modified":"2025-06-10T21:41:01","modified_gmt":"2025-06-10T21:41:01","slug":"medical-device-grouping-as-a-system-in-mexico-criteria-and-practical-examples","status":"publish","type":"post","link":"https:\/\/veraqueconsulting.com\/mx\/medical-device-grouping-as-a-system-in-mexico-criteria-and-practical-examples\/","title":{"rendered":"Medical Device Grouping as a System in Mexico: Criteria and Practical Examples\u00a0 \u00a0"},"content":{"rendered":"

Obtaining a <\/span>sanitary registration<\/span><\/a> in Mexico is mandatory for marketing a medical device in the country. Typically, each device requires its own registration based on factors such as the manufacturer, intended use, technology, and materials. However, in some cases, multiple devices can be grouped under a single registration as a <\/span>system<\/span><\/i>, a regulatory strategy that improves efficiency and approval timelines.<\/span>\u00a0<\/span><\/p>\n

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With increasing numbers of medical devices meeting the definition of a system, understanding Mexico\u2019s grouping criteria is essential. In this article, we explore the regulatory definition, compare it with other regions, and provide practical examples to illustrate how manufacturers can apply this approach.<\/span>\u00a0<\/span><\/p>\n

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What Defines a Medical Device System?<\/span><\/b>\u00a0<\/span><\/h3>\n

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While Mexico\u2019s regulatory framework is influenced by international standards, the grouping criteria for medical device systems have specific nuances. Let\u2019s examine how different regions define a system:<\/span>\u00a0<\/span><\/p>\n

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  1. European Union (<\/span><\/b>MDR<\/span><\/b><\/a> Definition)<\/span><\/b><\/li>\n<\/ol>\n

    A <\/span>system<\/span><\/i> refers to a combination of products (packaged together or separately) intended to be interconnected or combined to achieve a specific medical purpose.<\/span>\u00a0<\/span><\/p>\n

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    1. Canada (<\/span><\/b>Medical Devices Regulations<\/span><\/b><\/a>)<\/span><\/b><\/li>\n<\/ol>\n

      A <\/span>system<\/span><\/i> is a medical device comprising multiple components designed to be used together to fulfill some or all of its intended functions, sold under a single name.<\/span>\u00a0<\/span><\/p>\n

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      1. Mexico\u2019s Definition (<\/span><\/b>Mexican Pharmacopeia Supplement<\/span><\/b><\/a>, Section 4.2)<\/span><\/b><\/li>\n<\/ol>\n

        “Supplies that are packaged together or not, intended to be interconnected or combined for the purpose of achieving a specific medical purpose, and that have the same indication for use, when used for the same medical procedure or otherwise justified in the system, may be registered as a <\/span>system<\/span><\/i>.”<\/span>\u00a0<\/span><\/p>\n

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        Practical Examples: How to Apply Mexico\u2019s System Criteria<\/span><\/b>\u00a0<\/span><\/h3>\n

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        To determine if your medical device qualifies as a system, ask these key questions:<\/span>\u00a0<\/span><\/p>\n