{"id":4422,"date":"2026-09-08T21:04:27","date_gmt":"2026-09-08T21:04:27","guid":{"rendered":"https:\/\/veraqueconsulting.com\/mx\/?p=4422"},"modified":"2026-09-08T21:04:27","modified_gmt":"2026-09-08T21:04:27","slug":"samd-vs-simd-in-mexico","status":"publish","type":"post","link":"https:\/\/veraqueconsulting.com\/mx\/samd-vs-simd-in-mexico\/","title":{"rendered":"SaMD vs SiMD in Mexico: Understanding the Difference Under COFEPRIS"},"content":{"rendered":"<p><span data-contrast=\"auto\">Software has become a fundamental\u00a0component\u00a0of modern healthcare. From artificial intelligence applications that support diagnosis to embedded software controlling pacemakers and infusion pumps, software now plays a direct role in patient care. As a result, manufacturers\u00a0frequently\u00a0face an important regulatory question: is the software considered a medical device by itself, or is it software that forms part of a medical device?\u00a0<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;201341983&quot;:0,&quot;335559738&quot;:210,&quot;335559739&quot;:210,&quot;335559740&quot;:300}\">\u00a0<\/span><\/p>\n<p><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;201341983&quot;:0,&quot;335559738&quot;:210,&quot;335559739&quot;:210,&quot;335559740&quot;:300}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">Understanding the distinction between\u00a0<\/span><b><span data-contrast=\"auto\">Software as a Medical Device (SaMD)<\/span><\/b><span data-contrast=\"auto\">\u00a0and\u00a0<\/span><b><span data-contrast=\"auto\">Software in a Medical Device (SiMD)<\/span><\/b><span data-contrast=\"auto\">\u00a0is essential for\u00a0establishing\u00a0the correct regulatory strategy, defining quality system requirements, and planning market access activities in Mexico and other\u00a0jurisdictions.\u00a0<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;201341983&quot;:0,&quot;335559738&quot;:210,&quot;335559739&quot;:210,&quot;335559740&quot;:300}\">\u00a0<\/span><\/p>\n<p><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;201341983&quot;:0,&quot;335559738&quot;:210,&quot;335559739&quot;:210,&quot;335559740&quot;:300}\">\u00a0<\/span><\/p>\n<h3><b><span data-contrast=\"auto\">What Is Software\u00a0as\u00a0a Medical Device (SaMD)?<\/span><\/b><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;201341983&quot;:0,&quot;335559738&quot;:261,&quot;335559739&quot;:261,&quot;335559740&quot;:300}\">\u00a0<\/span><\/h3>\n<p><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;201341983&quot;:0,&quot;335559738&quot;:261,&quot;335559739&quot;:261,&quot;335559740&quot;:300}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">The concept of Software as a Medical Device (SaMD) has been widely adopted by regulatory authorities around the world. According to the framework recognized by Mexico, SaMD refers to software intended for one or more medical purposes that does not need to be part of the hardware of a medical device to fulfill its intended medical purpose. Such software can\u00a0operate\u00a0on general-purpose computing platforms and may function independently or in combination with other products. Mobile applications may also fall within this category.<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;201341983&quot;:0,&quot;335559738&quot;:210,&quot;335559739&quot;:210,&quot;335559740&quot;:300}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">Examples may include:<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;201341983&quot;:0,&quot;335559738&quot;:210,&quot;335559739&quot;:210,&quot;335559740&quot;:300}\">\u00a0<\/span><\/p>\n<ul>\n<li data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"1\" 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;hybridMultilevel&quot;}\" data-aria-posinset=\"1\" data-aria-level=\"1\"><span data-contrast=\"auto\">Software that analyzes medical images to\u00a0identify\u00a0potential pathologies.\u00a0<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;201341983&quot;:0,&quot;335559738&quot;:0,&quot;335559739&quot;:0,&quot;335559740&quot;:300}\">\u00a0<\/span><\/li>\n<\/ul>\n<ul>\n<li data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"1\" 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;hybridMultilevel&quot;}\" data-aria-posinset=\"2\" data-aria-level=\"1\"><span data-contrast=\"auto\">Software that analyzes patient information and recommends drug dosing.\u00a0<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;201341983&quot;:0,&quot;335559738&quot;:0,&quot;335559739&quot;:0,&quot;335559740&quot;:300}\">\u00a0<\/span><\/li>\n<\/ul>\n<ul>\n<li data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"1\" 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;hybridMultilevel&quot;}\" data-aria-posinset=\"3\" data-aria-level=\"1\"><span data-contrast=\"auto\">Applications that provide real-time monitoring of physiological parameters.\u00a0<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;201341983&quot;:0,&quot;335559738&quot;:0,&quot;335559739&quot;:0,&quot;335559740&quot;:300}\">\u00a0<\/span><\/li>\n<\/ul>\n<ul>\n<li data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"1\" 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;hybridMultilevel&quot;}\" data-aria-posinset=\"4\" data-aria-level=\"1\"><span data-contrast=\"auto\">Software that displays MRI images on a smartphone or other mobile device for clinical purposes.\u00a0<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;201341983&quot;:0,&quot;335559738&quot;:0,&quot;335559739&quot;:0,&quot;335559740&quot;:300}\">\u00a0<\/span><\/li>\n<\/ul>\n<p><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;201341983&quot;:0,&quot;335559685&quot;:720,&quot;335559738&quot;:0,&quot;335559739&quot;:0,&quot;335559740&quot;:300}\">\u00a0<\/span><\/p>\n<h3><b><span data-contrast=\"auto\">What Is Software in a Medical Device (SiMD)?<\/span><\/b><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;201341983&quot;:0,&quot;335559738&quot;:261,&quot;335559739&quot;:261,&quot;335559740&quot;:300}\">\u00a0<\/span><\/h3>\n<p><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;201341983&quot;:0,&quot;335559738&quot;:261,&quot;335559739&quot;:261,&quot;335559740&quot;:300}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">Software in a Medical Device (SiMD), often referred to as embedded software or firmware, is software that enables a medical device to function according to its intended purpose. Unlike SaMD,\u00a0SiMD\u00a0does not independently perform a medical purpose. Instead, it supports, drives, controls, or\u00a0operates\u00a0a physical medical device.\u00a0<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;201341983&quot;:0,&quot;335559738&quot;:210,&quot;335559739&quot;:210,&quot;335559740&quot;:300}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">Common examples include:<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;201341983&quot;:0,&quot;335559738&quot;:210,&quot;335559739&quot;:210,&quot;335559740&quot;:300}\">\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;hybridMultilevel&quot;}\" data-aria-posinset=\"1\" data-aria-level=\"1\"><span data-contrast=\"auto\">Software that controls motors within an infusion pump.\u00a0<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;201341983&quot;:0,&quot;335559738&quot;:0,&quot;335559739&quot;:0,&quot;335559740&quot;:300}\">\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;hybridMultilevel&quot;}\" data-aria-posinset=\"2\" data-aria-level=\"1\"><span data-contrast=\"auto\">Software responsible for closed-loop control functions.\u00a0<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;201341983&quot;:0,&quot;335559738&quot;:0,&quot;335559739&quot;:0,&quot;335559740&quot;:300}\">\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;hybridMultilevel&quot;}\" data-aria-posinset=\"3\" data-aria-level=\"1\"><span data-contrast=\"auto\">Embedded software used to\u00a0operate\u00a0patient monitoring equipment.\u00a0<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;201341983&quot;:0,&quot;335559738&quot;:0,&quot;335559739&quot;:0,&quot;335559740&quot;:300}\">\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;hybridMultilevel&quot;}\" data-aria-posinset=\"4\" data-aria-level=\"1\"><span data-contrast=\"auto\">Firmware that enables a medical device to perform its intended function.\u00a0<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;201341983&quot;:0,&quot;335559738&quot;:0,&quot;335559739&quot;:0,&quot;335559740&quot;:300}\">\u00a0<\/span><\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<p><span data-contrast=\"auto\">In these situations,\u00a0if the software were removed, the device would no longer function as intended.<\/span><\/p>\n<p><span data-contrast=\"auto\">\u00a0<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;201341983&quot;:0,&quot;335559738&quot;:210,&quot;335559739&quot;:210,&quot;335559740&quot;:300}\">\u00a0<\/span><\/p>\n<h3><b><span data-contrast=\"auto\">The Key Distinction Between SaMD and\u00a0SiMD<\/span><\/b><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;201341983&quot;:0,&quot;335559738&quot;:261,&quot;335559739&quot;:261,&quot;335559740&quot;:300}\">\u00a0<\/span><\/h3>\n<p>&nbsp;<\/p>\n<p><span data-contrast=\"auto\">The difference between SaMD and\u00a0SiMD\u00a0can usually be reduced to a simple question:<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;201341983&quot;:0,&quot;335559738&quot;:210,&quot;335559739&quot;:210,&quot;335559740&quot;:300}\">\u00a0<\/span><\/p>\n<p style=\"text-align: center\"><b><span data-contrast=\"auto\">Does the software perform the medical purpose independently, or does it exist to enable a hardware medical device to perform that purpose?<\/span><\/b><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;201341983&quot;:0,&quot;335559738&quot;:210,&quot;335559739&quot;:210,&quot;335559740&quot;:300}\">\u00a0<\/span><\/p>\n<p>&nbsp;<\/p>\n<p><span data-contrast=\"auto\">If the software independently diagnoses, treats, monitors, predicts, or provides information for clinical decisions, it is more likely to be considered SaMD. Conversely, if the software exists solely to support the functioning of a hardware device, it is\u00a0generally considered\u00a0SiMD.\u00a0<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;201341983&quot;:0,&quot;335559738&quot;:210,&quot;335559739&quot;:210,&quot;335559740&quot;:300}\">\u00a0<\/span><\/p>\n<p><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;201341983&quot;:0,&quot;335559738&quot;:210,&quot;335559739&quot;:210,&quot;335559740&quot;:300}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">The distinction is\u00a0closely linked\u00a0to the software&#8217;s intended use. As discussed in our\u00a0previous\u00a0article on\u00a0<\/span><a href=\"https:\/\/veraqueconsulting.com\/mx\/samd-classification-strategy-how-medical-device-manufacturers-should-approach-software-risk\/\" target=\"_blank\" rel=\"noopener\"><span data-contrast=\"none\">SaMD classification strategy<\/span><\/a><span data-contrast=\"auto\">, intended use serves as the foundation for\u00a0determining\u00a0whether software is a medical device and influences\u00a0subsequent\u00a0classification and regulatory decisions.\u00a0<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;201341983&quot;:0,&quot;335559738&quot;:210,&quot;335559739&quot;:210,&quot;335559740&quot;:300}\">\u00a0<\/span><\/p>\n<p><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;201341983&quot;:0,&quot;335559738&quot;:210,&quot;335559739&quot;:210,&quot;335559740&quot;:300}\">\u00a0<\/span><\/p>\n<h3><b><span data-contrast=\"auto\">How COFEPRIS Approaches SaMD and\u00a0SiMD<\/span><\/b><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;201341983&quot;:0,&quot;335559738&quot;:261,&quot;335559739&quot;:261,&quot;335559740&quot;:300}\">\u00a0<\/span><\/h3>\n<p>&nbsp;<\/p>\n<p><span data-contrast=\"auto\">Mexico has taken important steps toward regulating software-based medical technologies. The <a href=\"https:\/\/veraqueconsulting.com\/mx\/medical-device-supplement-from-the-mexican-pharmacopoeia\/\" target=\"_blank\" rel=\"noopener\">Supplement for Medical Devices of the Mexican Pharmacopoeia<\/a> formally recognizes SaMD and provides a definition closely aligned with international approaches. According to this framework, software that fulfills a medical purpose independently may be considered SaMD. At the same time, software that\u00a0facilitates\u00a0the functioning of a medical device is specifically excluded from the SaMD definition.<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;201341983&quot;:0,&quot;335559738&quot;:210,&quot;335559739&quot;:210,&quot;335559740&quot;:300}\">\u00a0<\/span><\/p>\n<p><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;201341983&quot;:0,&quot;335559738&quot;:210,&quot;335559739&quot;:210,&quot;335559740&quot;:300}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">This means that, from a COFEPRIS perspective, manufacturers should not assume that all healthcare-related software automatically qualifies as SaMD. The regulatory assessment must evaluate both the intended medical purpose and the relationship between the software and any associated hardware device.<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;201341983&quot;:0,&quot;335559738&quot;:210,&quot;335559739&quot;:210,&quot;335559740&quot;:300}\">\u00a0<\/span><\/p>\n<p><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;201341983&quot;:0,&quot;335559738&quot;:210,&quot;335559739&quot;:210,&quot;335559740&quot;:300}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">Furthermore, <a href=\"https:\/\/veraqueconsulting.com\/mx\/nom241-for-medical-device-good-manufacturing-practices-in-mexico\/\" target=\"_blank\" rel=\"noopener\">NOM-241-SSA1-2025<\/a> incorporates the concept of SaMD into Mexico&#8217;s Good Manufacturing Practices framework and recognizes software that\u00a0operates\u00a0independently from hardware medical devices while excluding software intended to\u00a0operate\u00a0the device itself.\u00a0<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;201341983&quot;:0,&quot;335559738&quot;:210,&quot;335559739&quot;:210,&quot;335559740&quot;:300}\">\u00a0<\/span><\/p>\n<p><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;201341983&quot;:0,&quot;335559738&quot;:261,&quot;335559739&quot;:261,&quot;335559740&quot;:300}\">\u00a0<\/span><\/p>\n<h3><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;201341983&quot;:0,&quot;335559738&quot;:261,&quot;335559739&quot;:261,&quot;335559740&quot;:300}\">\u00a0<\/span><\/h3>\n<h3><b><span data-contrast=\"auto\">SaMD and\u00a0SiMD\u00a0Terminology in Mexican Regulations:\u00a0ScDM\u00a0and\u00a0SeDM<\/span><\/b><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;201341983&quot;:0,&quot;335559738&quot;:261,&quot;335559739&quot;:261,&quot;335559740&quot;:300}\">\u00a0<\/span><\/h3>\n<p>&nbsp;<\/p>\n<p><span data-contrast=\"auto\">Manufacturers reviewing Mexican regulations may notice that the terms commonly used in English,\u00a0<\/span><b><span data-contrast=\"auto\">Software as a Medical Device (SaMD)<\/span><\/b><span data-contrast=\"auto\">\u00a0and\u00a0<\/span><b><span data-contrast=\"auto\">Software in a Medical Device (SiMD)<\/span><\/b><span data-contrast=\"auto\">, may appear under their Spanish equivalents.<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;201341983&quot;:0,&quot;335559738&quot;:210,&quot;335559739&quot;:210,&quot;335559740&quot;:300}\">\u00a0<\/span><\/p>\n<p><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;201341983&quot;:0,&quot;335559738&quot;:210,&quot;335559739&quot;:210,&quot;335559740&quot;:300}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">In the Mexican regulatory framework, Software as a Medical Device is commonly referred to as\u00a0<\/span><b><span data-contrast=\"auto\">Software\u00a0como\u00a0Dispositivo\u00a0M\u00e9dico (ScDM)<\/span><\/b><span data-contrast=\"auto\">. This terminology appears in documents such as the Supplement for Medical Devices of the Mexican Pharmacopoeia and NOM-241-SSA1-2025, where the concept follows the same general principles adopted by the IMDRF.\u00a0<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;201341983&quot;:0,&quot;335559738&quot;:210,&quot;335559739&quot;:210,&quot;335559740&quot;:300}\">\u00a0<\/span><\/p>\n<p><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;201341983&quot;:0,&quot;335559738&quot;:210,&quot;335559739&quot;:210,&quot;335559740&quot;:300}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">Although Mexican regulations primarily focus on defining\u00a0ScDM\u00a0(SaMD), manufacturers and regulatory professionals often use the term\u00a0<\/span><b><span data-contrast=\"auto\">Software\u00a0en\u00a0un\u00a0Dispositivo\u00a0M\u00e9dico (SeDM)<\/span><\/b><span data-contrast=\"auto\">\u00a0as the Spanish equivalent of Software in a Medical Device (SiMD). This term\u00a0generally refers\u00a0to embedded software, firmware, or software required for a medical device to achieve its intended purpose. Software that\u00a0facilitates\u00a0the functioning of a medical device is specifically excluded from the Mexican definition of\u00a0ScDM.\u00a0<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;201341983&quot;:0,&quot;335559738&quot;:210,&quot;335559739&quot;:210,&quot;335559740&quot;:300}\">\u00a0<\/span><\/p>\n<p><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;201341983&quot;:0,&quot;335559738&quot;:210,&quot;335559739&quot;:210,&quot;335559740&quot;:300}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">For international companies preparing regulatory submissions in Mexico, it may therefore be useful to recognize the following terminology:<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;201341983&quot;:0,&quot;335559738&quot;:210,&quot;335559739&quot;:210,&quot;335559740&quot;:300}\">\u00a0<\/span><\/p>\n<table data-tablestyle=\"MsoNormalTable\" data-tablelook=\"1696\">\n<tbody>\n<tr>\n<td data-celllook=\"69905\"><b><span data-contrast=\"auto\">English Term<\/span><\/b><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;201341983&quot;:0,&quot;335551550&quot;:2,&quot;335551620&quot;:2,&quot;335559738&quot;:0,&quot;335559739&quot;:0,&quot;335559740&quot;:300}\">\u00a0<\/span><\/td>\n<td data-celllook=\"69905\"><b><span data-contrast=\"auto\">Spanish Term<\/span><\/b><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;201341983&quot;:0,&quot;335551550&quot;:2,&quot;335551620&quot;:2,&quot;335559738&quot;:0,&quot;335559739&quot;:0,&quot;335559740&quot;:300}\">\u00a0<\/span><\/td>\n<td data-celllook=\"69905\"><b><span data-contrast=\"auto\">Acronym<\/span><\/b><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;201341983&quot;:0,&quot;335551550&quot;:2,&quot;335551620&quot;:2,&quot;335559738&quot;:0,&quot;335559739&quot;:0,&quot;335559740&quot;:300}\">\u00a0<\/span><\/td>\n<\/tr>\n<tr>\n<td data-celllook=\"4369\"><span data-contrast=\"auto\">Software as a Medical Device<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;201341983&quot;:0,&quot;335559738&quot;:0,&quot;335559739&quot;:0,&quot;335559740&quot;:300}\">\u00a0<\/span><\/td>\n<td data-celllook=\"4369\"><span data-contrast=\"auto\">Software\u00a0como\u00a0Dispositivo\u00a0M\u00e9dico<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;201341983&quot;:0,&quot;335559738&quot;:0,&quot;335559739&quot;:0,&quot;335559740&quot;:300}\">\u00a0<\/span><\/td>\n<td data-celllook=\"4369\"><span data-contrast=\"auto\">ScDM<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;201341983&quot;:0,&quot;335559738&quot;:0,&quot;335559739&quot;:0,&quot;335559740&quot;:300}\">\u00a0<\/span><\/td>\n<\/tr>\n<tr>\n<td data-celllook=\"4369\"><span data-contrast=\"auto\">Software in a Medical Device<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;201341983&quot;:0,&quot;335559738&quot;:0,&quot;335559739&quot;:0,&quot;335559740&quot;:300}\">\u00a0<\/span><\/td>\n<td data-celllook=\"4369\"><span data-contrast=\"auto\">Software\u00a0en\u00a0un\u00a0Dispositivo\u00a0M\u00e9dico<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;201341983&quot;:0,&quot;335559738&quot;:0,&quot;335559739&quot;:0,&quot;335559740&quot;:300}\">\u00a0<\/span><\/td>\n<td data-celllook=\"4369\"><span data-contrast=\"auto\">SeDM<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;201341983&quot;:0,&quot;335559738&quot;:0,&quot;335559739&quot;:0,&quot;335559740&quot;:300}\">\u00a0<\/span><\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;201341983&quot;:0,&quot;335559738&quot;:210,&quot;335559739&quot;:210,&quot;335559740&quot;:300}\">\u00a0<\/span><\/p>\n<h3><\/h3>\n<h3><b><span data-contrast=\"auto\">Practical Examples Under the Mexican Framework<\/span><\/b><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;201341983&quot;:0,&quot;335559738&quot;:261,&quot;335559739&quot;:261,&quot;335559740&quot;:300}\">\u00a0<\/span><\/h3>\n<p><span data-contrast=\"auto\">The following examples illustrate how the distinction may be applied in practice:<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;201341983&quot;:0,&quot;335559738&quot;:210,&quot;335559739&quot;:210,&quot;335559740&quot;:300}\">\u00a0<\/span><\/p>\n<table data-tablestyle=\"MsoNormalTable\" data-tablelook=\"1696\">\n<tbody>\n<tr>\n<td data-celllook=\"69905\"><b><span data-contrast=\"auto\">Software Function<\/span><\/b><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;201341983&quot;:0,&quot;335551550&quot;:2,&quot;335551620&quot;:2,&quot;335559738&quot;:0,&quot;335559739&quot;:0,&quot;335559740&quot;:300}\">\u00a0<\/span><\/td>\n<td data-celllook=\"69905\"><b><span data-contrast=\"auto\">Likely Category<\/span><\/b><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;201341983&quot;:0,&quot;335551550&quot;:2,&quot;335551620&quot;:2,&quot;335559738&quot;:0,&quot;335559739&quot;:0,&quot;335559740&quot;:300}\">\u00a0<\/span><\/td>\n<td data-celllook=\"69905\"><b><span data-contrast=\"auto\">Rationale<\/span><\/b><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;201341983&quot;:0,&quot;335551550&quot;:2,&quot;335551620&quot;:2,&quot;335559738&quot;:0,&quot;335559739&quot;:0,&quot;335559740&quot;:300}\">\u00a0<\/span><\/td>\n<\/tr>\n<tr>\n<td data-celllook=\"4369\"><span data-contrast=\"auto\">AI software that analyzes CT or MRI images for diagnostic purposes<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;201341983&quot;:0,&quot;335559738&quot;:0,&quot;335559739&quot;:0,&quot;335559740&quot;:300}\">\u00a0<\/span><\/td>\n<td data-celllook=\"4369\"><span data-contrast=\"auto\">SaMD<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;201341983&quot;:0,&quot;335559738&quot;:0,&quot;335559739&quot;:0,&quot;335559740&quot;:300}\">\u00a0<\/span><\/td>\n<td data-celllook=\"4369\"><span data-contrast=\"auto\">Performs an independent medical purpose through data analysis.\u00a0<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;201341983&quot;:0,&quot;335559738&quot;:0,&quot;335559739&quot;:0,&quot;335559740&quot;:300}\">\u00a0<\/span><\/td>\n<\/tr>\n<tr>\n<td data-celllook=\"4369\"><span data-contrast=\"auto\">Mobile application that recommends insulin dosage based on patient data<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;201341983&quot;:0,&quot;335559738&quot;:0,&quot;335559739&quot;:0,&quot;335559740&quot;:300}\">\u00a0<\/span><\/td>\n<td data-celllook=\"4369\"><span data-contrast=\"auto\">SaMD<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;201341983&quot;:0,&quot;335559738&quot;:0,&quot;335559739&quot;:0,&quot;335559740&quot;:300}\">\u00a0<\/span><\/td>\n<td data-celllook=\"4369\"><span data-contrast=\"auto\">Generates information used for clinical decision-making.\u00a0<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;201341983&quot;:0,&quot;335559738&quot;:0,&quot;335559739&quot;:0,&quot;335559740&quot;:300}\">\u00a0<\/span><\/td>\n<\/tr>\n<tr>\n<td data-celllook=\"4369\"><span data-contrast=\"auto\">Software displaying MRI images on a mobile device<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;201341983&quot;:0,&quot;335559738&quot;:0,&quot;335559739&quot;:0,&quot;335559740&quot;:300}\">\u00a0<\/span><\/td>\n<td data-celllook=\"4369\"><span data-contrast=\"auto\">SaMD<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;201341983&quot;:0,&quot;335559738&quot;:0,&quot;335559739&quot;:0,&quot;335559740&quot;:300}\">\u00a0<\/span><\/td>\n<td data-celllook=\"4369\"><span data-contrast=\"auto\">Provides a medical function without operating hardware.\u00a0<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;201341983&quot;:0,&quot;335559738&quot;:0,&quot;335559739&quot;:0,&quot;335559740&quot;:300}\">\u00a0<\/span><\/td>\n<\/tr>\n<tr>\n<td data-celllook=\"4369\"><span data-contrast=\"auto\">Firmware controlling an infusion pump motor<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;201341983&quot;:0,&quot;335559738&quot;:0,&quot;335559739&quot;:0,&quot;335559740&quot;:300}\">\u00a0<\/span><\/td>\n<td data-celllook=\"4369\"><span data-contrast=\"auto\">SiMD<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;201341983&quot;:0,&quot;335559738&quot;:0,&quot;335559739&quot;:0,&quot;335559740&quot;:300}\">\u00a0<\/span><\/td>\n<td data-celllook=\"4369\"><span data-contrast=\"auto\">Exists\u00a0to\u00a0operate\u00a0the device.\u00a0<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;201341983&quot;:0,&quot;335559738&quot;:0,&quot;335559739&quot;:0,&quot;335559740&quot;:300}\">\u00a0<\/span><\/td>\n<\/tr>\n<tr>\n<td data-celllook=\"4369\"><span data-contrast=\"auto\">Closed-loop control software within a medical device<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;201341983&quot;:0,&quot;335559738&quot;:0,&quot;335559739&quot;:0,&quot;335559740&quot;:300}\">\u00a0<\/span><\/td>\n<td data-celllook=\"4369\"><span data-contrast=\"auto\">SiMD<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;201341983&quot;:0,&quot;335559738&quot;:0,&quot;335559739&quot;:0,&quot;335559740&quot;:300}\">\u00a0<\/span><\/td>\n<td data-celllook=\"4369\"><span data-contrast=\"auto\">Supports hardware functionality and intended use.<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;201341983&quot;:0,&quot;335559738&quot;:0,&quot;335559739&quot;:0,&quot;335559740&quot;:300}\">\u00a0<\/span><\/td>\n<\/tr>\n<tr>\n<td data-celllook=\"4369\"><span data-contrast=\"auto\">Software used to\u00a0monitor\u00a0equipment maintenance or error codes<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;201341983&quot;:0,&quot;335559738&quot;:0,&quot;335559739&quot;:0,&quot;335559740&quot;:300}\">\u00a0<\/span><\/td>\n<td data-celllook=\"4369\"><span data-contrast=\"auto\">Not typically SaMD<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;201341983&quot;:0,&quot;335559738&quot;:0,&quot;335559739&quot;:0,&quot;335559740&quot;:300}\">\u00a0<\/span><\/td>\n<td data-celllook=\"4369\"><span data-contrast=\"auto\">Does not perform a medical purpose.\u00a0<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;201341983&quot;:0,&quot;335559738&quot;:0,&quot;335559739&quot;:0,&quot;335559740&quot;:300}\">\u00a0<\/span><\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p><span data-contrast=\"auto\">These examples\u00a0demonstrate\u00a0that the determination is driven primarily by intended use and functional independence rather than by the technology platform itself.\u00a0<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;201341983&quot;:0,&quot;335559738&quot;:210,&quot;335559739&quot;:210,&quot;335559740&quot;:300}\">\u00a0<\/span><\/p>\n<p><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;201341983&quot;:0,&quot;335559738&quot;:261,&quot;335559739&quot;:261,&quot;335559740&quot;:300}\">\u00a0<\/span><\/p>\n<h3><b><span data-contrast=\"auto\">Why the Distinction Matters<\/span><\/b><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;201341983&quot;:0,&quot;335559738&quot;:261,&quot;335559739&quot;:261,&quot;335559740&quot;:300}\">\u00a0<\/span><\/h3>\n<p>&nbsp;<\/p>\n<p><span data-contrast=\"auto\">The distinction between SaMD and\u00a0SiMD\u00a0is more than a terminology exercise. It can affect multiple regulatory and development activities.<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;201341983&quot;:0,&quot;335559738&quot;:210,&quot;335559739&quot;:210,&quot;335559740&quot;:300}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">First, it helps\u00a0determine\u00a0whether software should be evaluated as an independent medical device or as part of a broader medical device system. Second, it may influence the classification rationale, technical documentation strategy, and evidence requirements. Finally, it supports the development of\u00a0appropriate risk\u00a0management, software lifecycle, cybersecurity, and quality management activities.<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;201341983&quot;:0,&quot;335559738&quot;:210,&quot;335559739&quot;:210,&quot;335559740&quot;:300}\">\u00a0<\/span><\/p>\n<p><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;201341983&quot;:0,&quot;335559738&quot;:210,&quot;335559739&quot;:210,&quot;335559740&quot;:300}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">Manufacturers should also remember that regulatory classification and software safety classification are different concepts.\u00a0A software product may require significant software lifecycle controls even when its regulatory classification is\u00a0relatively low. Therefore,\u00a0determining\u00a0whether a product is SaMD or\u00a0SiMD\u00a0should be viewed as an early step within a broader regulatory strategy.\u00a0<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;201341983&quot;:0,&quot;335559738&quot;:210,&quot;335559739&quot;:210,&quot;335559740&quot;:300}\">\u00a0<\/span><\/p>\n<p><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;201341983&quot;:0,&quot;335559738&quot;:261,&quot;335559739&quot;:261,&quot;335559740&quot;:300}\">\u00a0<\/span><\/p>\n<h3><b><span data-contrast=\"auto\">Questions Manufacturers Should Ask<\/span><\/b><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;201341983&quot;:0,&quot;335559738&quot;:261,&quot;335559739&quot;:261,&quot;335559740&quot;:300}\">\u00a0<\/span><\/h3>\n<p>&nbsp;<\/p>\n<p><span data-contrast=\"auto\">When evaluating software under the Mexican regulatory framework, the following questions may be useful:<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;201341983&quot;:0,&quot;335559738&quot;:210,&quot;335559739&quot;:210,&quot;335559740&quot;:300}\">\u00a0<\/span><\/p>\n<ol>\n<li><span data-contrast=\"auto\">Does the software have a medical purpose?<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;201341983&quot;:0,&quot;335559738&quot;:0,&quot;335559739&quot;:0,&quot;335559740&quot;:300}\">\u00a0<\/span><\/li>\n<li><span data-contrast=\"auto\">Does the software independently diagnose, treat, monitor, predict, or provide information related to patient care?<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;201341983&quot;:0,&quot;335559738&quot;:0,&quot;335559739&quot;:0,&quot;335559740&quot;:300}\">\u00a0<\/span><\/li>\n<li><span data-contrast=\"auto\">Can the software fulfill its intended purpose without being part of a hardware medical device?<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;201341983&quot;:0,&quot;335559738&quot;:0,&quot;335559739&quot;:0,&quot;335559740&quot;:300}\">\u00a0<\/span><\/li>\n<li><span data-contrast=\"auto\">Is the software intended to drive, control, or\u00a0operate\u00a0a medical device?<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;201341983&quot;:0,&quot;335559738&quot;:0,&quot;335559739&quot;:0,&quot;335559740&quot;:300}\">\u00a0<\/span><\/li>\n<li><span data-contrast=\"auto\">Would the hardware medical device still achieve its intended purpose if the software were removed?<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;201341983&quot;:0,&quot;335559738&quot;:0,&quot;335559739&quot;:0,&quot;335559740&quot;:300}\">\u00a0<\/span><\/li>\n<\/ol>\n<p><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;201341983&quot;:0,&quot;335559738&quot;:210,&quot;335559739&quot;:210,&quot;335559740&quot;:300}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">The answers to these questions can help\u00a0establish\u00a0whether the software is more appropriately viewed as SaMD,\u00a0SiMD, or software that falls outside the scope of medical device regulation altogether.<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;201341983&quot;:0,&quot;335559738&quot;:210,&quot;335559739&quot;:210,&quot;335559740&quot;:300}\">\u00a0<\/span><\/p>\n<p><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;201341983&quot;:0,&quot;335559738&quot;:261,&quot;335559739&quot;:261,&quot;335559740&quot;:300}\">\u00a0<\/span><\/p>\n<h3><b><span data-contrast=\"auto\">Frequently Asked Questions (FAQ)<\/span><\/b><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;201341983&quot;:0,&quot;335559738&quot;:261,&quot;335559739&quot;:261,&quot;335559740&quot;:300}\"> &#8211; SaMD vs SiMD<\/span><\/h3>\n<p>&nbsp;<\/p>\n<ol>\n<li><span data-contrast=\"auto\"> What is the main difference between SaMD andSiMD?<\/span><\/li>\n<\/ol>\n<p><span data-contrast=\"auto\">The primary difference is the role of the software. SaMD independently performs a medical purpose, such as analyzing patient data or supporting diagnosis, while\u00a0SiMD\u00a0is software that enables a medical device to function according to its intended purpose.\u00a0<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;201341983&quot;:0,&quot;335559738&quot;:261,&quot;335559739&quot;:261,&quot;335559740&quot;:300}\">\u00a0<\/span><\/p>\n<ol start=\"2\">\n<li><span data-contrast=\"auto\"> Does COFEPRIS regulate both SaMD andSiMD?<\/span><\/li>\n<\/ol>\n<p><span data-contrast=\"auto\">Yes. COFEPRIS regulates medical devices that incorporate software, including both SaMD and software that forms part of a medical device. However, software that qualifies as SaMD is evaluated as a standalone medical device software product,\u00a0whereas\u00a0embedded software is\u00a0generally assessed\u00a0as part of the overall medical device system. The intended use of the software\u00a0remains\u00a0a critical factor in\u00a0determining\u00a0the applicable regulatory approach.<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;201341983&quot;:0,&quot;335559738&quot;:261,&quot;335559739&quot;:261,&quot;335559740&quot;:300}\">\u00a0<\/span><\/p>\n<ol start=\"3\">\n<li><span data-contrast=\"auto\"> How can manufacturersdeterminewhether their software is SaMD or\u00a0SiMD?<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;201341983&quot;:0,&quot;335559738&quot;:261,&quot;335559739&quot;:261,&quot;335559740&quot;:300}\">\u00a0<\/span><\/li>\n<\/ol>\n<p><span data-contrast=\"auto\">Manufacturers should begin by assessing the intended use of the software and its relationship with any associated hardware. If the software independently performs a medical purpose, it may be considered SaMD. If it is\u00a0required\u00a0for a medical device to\u00a0operate\u00a0as intended, it is more likely to be considered\u00a0SiMD. Performing this assessment early can help support classification decisions and regulatory planning with COFEPRIS.<\/span><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;335559685&quot;:0,&quot;335559737&quot;:0,&quot;335559738&quot;:261,&quot;335559739&quot;:261,&quot;335559740&quot;:300}\">\u00a0<\/span><\/p>\n<p><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;201341983&quot;:0,&quot;335559738&quot;:261,&quot;335559739&quot;:261,&quot;335559740&quot;:300}\">\u00a0<\/span><\/p>\n<h3><b><span data-contrast=\"auto\">Conclusion<\/span><\/b><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;201341983&quot;:0,&quot;335559738&quot;:261,&quot;335559739&quot;:261,&quot;335559740&quot;:300}\">\u00a0<\/span><\/h3>\n<p><span data-contrast=\"auto\">Understanding the difference between SaMD and\u00a0SiMD\u00a0is an important first step when evaluating software under the Mexican regulatory framework. While SaMD refers to software that independently performs a medical purpose,\u00a0SiMD\u00a0refers to software that enables a medical device to function as intended.\u00a0Correctly\u00a0identifying\u00a0the category, together with the software&#8217;s intended use and relationship to hardware, can help manufacturers\u00a0establish\u00a0an effective regulatory strategy for interactions with COFEPRIS.<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;201341983&quot;:0,&quot;335559738&quot;:210,&quot;335559739&quot;:210,&quot;335559740&quot;:300}\">\u00a0<\/span><\/p>\n<p><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;201341983&quot;:0,&quot;335559738&quot;:210,&quot;335559739&quot;:210,&quot;335559740&quot;:300}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">If you are planning to bring SaMD,\u00a0SiMD, or other medical technologies to the Latin American market, trust\u00a0Veraque\u00a0as your regulatory partner. Contact us at\u00a0<\/span><a href=\"mailto:contact@veraqueconsulting.com\"><span data-contrast=\"none\">contact@veraqueconsulting.com<\/span><\/a><span data-contrast=\"auto\">\u00a0 to discuss your market access strategy and regulatory requirements.<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;201341983&quot;:0,&quot;335559738&quot;:210,&quot;335559739&quot;:210,&quot;335559740&quot;:300}\">\u00a0<\/span><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Software has become a fundamental\u00a0component\u00a0of modern healthcare. From artificial intelligence applications that support diagnosis to embedded software controlling pacemakers and infusion pumps, software now plays a direct role in patient care. As a result, manufacturers\u00a0frequently\u00a0face an important regulatory question: is the software considered a medical device by itself, or is it software that forms part [&hellip;]<\/p>\n","protected":false},"author":6,"featured_media":4423,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[390],"tags":[],"class_list":["post-4422","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","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>SaMD vs SiMD in Mexico - Veraque Mexico<\/title>\n<meta name=\"description\" content=\"Learn the differences between SaMD and SiMD under the Mexican regulatory framework. 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