{"id":3178,"date":"2023-07-28T01:13:18","date_gmt":"2023-07-28T01:13:18","guid":{"rendered":"https:\/\/veraqueconsulting.com\/mx\/?p=3178"},"modified":"2025-06-24T23:36:26","modified_gmt":"2025-06-24T23:36:26","slug":"classification-of-software-as-a-medical-device-in-mexico","status":"publish","type":"post","link":"https:\/\/veraqueconsulting.com\/mx\/classification-of-software-as-a-medical-device-in-mexico\/","title":{"rendered":"Classification of Software as a Medical Device in Mexico"},"content":{"rendered":"

As previously discussed in our article for Software as a Medical Device (SaMD)<\/a>, a significant development has occurred in the Mexican regulatory framework. The introduction of the first official approach to regulating SaMD marks a crucial step in the right direction, aiming to establish a faster and more comprehensive regulatory environment.<\/p>\n

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However, the rapid pace of advancements and innovation in the field of SaMD, creates a dynamic landscape. Consequently, there are often gaps in the understanding and comprehension of regulatory practices.<\/p>\n

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In this article, we will discuss in more detail what is considered SaMD in Mexico. Furthermore, we will provide some examples based on the new rules and practical classification scenarios.<\/p>\n

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Definition of Software as a Medical Device<\/h2>\n

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The definition of Software as a Medical Device in Mexico closely aligns with the definitions found in other regulatory frameworks. In fact, it closely follows the one established by the International Medical Device Regulators Forum (IMDRF)<\/a>, and reads as follows:<\/p>\n

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“Software as a Medical Device (SaMD) refers to software used with one or more medical purposes, characterized by the fact that it does not need to be part of the hardware of a medical device to fulfill its intended medical purpose. SaMD is capable of functioning on general computerized platforms and can be used independently or in combination with other products (e.g., as a module, with another medical device, etc.). Mobile apps that fit within this definition are also considered SaMD”<\/em><\/p>\n

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It is important to note that, if the software is needed for a medical device to function properly, it is automatically excluded from the prior definition.<\/p>\n

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What software could be classified as a Medical Device?<\/h2>\n

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By its own nature, trying to conceptualize software can sometimes be challenging, given that it is not a physical entity. Some SaMD examples are:<\/p>\n

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