{"id":3312,"date":"2026-02-20T18:11:06","date_gmt":"2026-02-20T18:11:06","guid":{"rendered":"https:\/\/veraqueconsulting.com\/cr\/?p=3312"},"modified":"2026-02-20T18:11:06","modified_gmt":"2026-02-20T18:11:06","slug":"software-as-a-medical-device-samd-in-costa-rica-regulatory-framework-and-definitions","status":"publish","type":"post","link":"https:\/\/veraqueconsulting.com\/cr\/software-as-a-medical-device-samd-in-costa-rica-regulatory-framework-and-definitions\/","title":{"rendered":"Software as a Medical Device (SaMD) in Costa Rica: Regulatory Framework and Definitions"},"content":{"rendered":"<p><span data-contrast=\"auto\">As digital health transforms the landscape of patient care in Latin America, Costa Rica has solidified its stance on digital therapeutics and diagnostic tools. Navigating the registration of health technology requires a precise understanding of how the\u00a0<\/span><a href=\"https:\/\/veraqueconsulting.com\/cr\/guides\/ultimate-guide-for-regulatory-affairs-in-costa-rica\/#ministry\" target=\"_blank\" rel=\"noopener\"><b><span data-contrast=\"none\">Ministry of Health<\/span><\/b><\/a><b><span data-contrast=\"auto\">\u00a0<\/span><\/b><span data-contrast=\"auto\">categorizes digital solutions.\u00a0<\/span><span data-ccp-props=\"{}\">\u00a0<\/span><\/p>\n<p><span data-ccp-props=\"{}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">In Costa Rica, software is not just a &#8220;tool&#8221;,\u00a0under specific conditions, it is a regulated medical entity. This guide breaks down the definition, characteristics, and exclusions of\u00a0<\/span><span data-contrast=\"auto\">Software as a Medical Device (SaMD)\u00a0<\/span><span data-contrast=\"auto\">under current Costa Rican law.<\/span><span data-ccp-props=\"{}\">\u00a0<\/span><\/p>\n<p><span data-ccp-props=\"{}\">\u00a0<\/span><\/p>\n<h3><b><span data-contrast=\"auto\">Definition of Software as a Medical\u00a0Device (SaMD)\u00a0in Costa Rica<\/span><\/b><span data-ccp-props=\"{}\">\u00a0<\/span><\/h3>\n<p><span data-ccp-props=\"{}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">In Costa Rica, the regulatory concept equivalent to a \u201cmedical device\u201d is known as Biomedical Equipment and Material (EMB \u2013 Equipo y Material\u00a0Biom\u00e9dico). Under the\u00a0national\u00a0regulatory framework, an EMB encompasses\u00a0all categories of\u00a0medical devices, including standalone software\u00a0intended for medical purposes. Throughout this document, the terms EMB and\u00a0<\/span><i><span data-contrast=\"auto\">medical device<\/span><\/i><span data-contrast=\"auto\">\u00a0will be used interchangeably to reflect this local classification.<\/span><span data-ccp-props=\"{}\">\u00a0<\/span><\/p>\n<p><span data-ccp-props=\"{}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">The definition of Software as a Medical Device (SaMD) in Costa Rica is aligned with international regulatory principles, including those\u00a0established\u00a0by the International Medical Device Regulators Forum (IMDRF).<\/span><span data-ccp-props=\"{}\">\u00a0<\/span><\/p>\n<p><span data-ccp-props=\"{}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">Costa Rica formalizes this concept through\u00a0<\/span><a href=\"https:\/\/pgrweb.go.cr\/scij\/Busqueda\/Normativa\/Normas\/nrm_texto_completo.aspx?nValor1=1&amp;nValor2=99003\" target=\"_blank\" rel=\"noopener\"><b><span data-contrast=\"none\">Decree No. 43902-S<\/span><\/b><\/a><span data-contrast=\"auto\">,\u00a0which defines Software as a Medical Device as follows:<\/span><span data-ccp-props=\"{}\">\u00a0<\/span><\/p>\n<p style=\"text-align: right\"><em>\u201cSoftware as Medical Equipment refers to software intended to be used for one or more medical purposes and that performs these purposes without being part of biomedical equipment or materials.\u201d\u00a0<\/em><\/p>\n<p><span data-ccp-props=\"{}\">\u00a0<\/span><\/p>\n<h3><b><span data-contrast=\"auto\">Regulatory Characteristics of SaMD in Costa Rica<\/span><\/b><span data-ccp-props=\"{}\">\u00a0<\/span><\/h3>\n<p><span data-ccp-props=\"{}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">According to the national regulation, this definition includes the following characteristics:<\/span><span data-ccp-props=\"{}\">\u00a0<\/span><\/p>\n<ul>\n<li data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"12\" 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;multilevel&quot;}\" data-aria-posinset=\"1\" data-aria-level=\"1\">Software as a Medical Device is considered a medical device (EMB), and includes software intended for\u00a0in vitro diagnostic (IVD)<span data-contrast=\"auto\"> purposes.<br \/>\n<\/span><\/li>\n<li data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"12\" 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;multilevel&quot;}\" data-aria-posinset=\"1\" data-aria-level=\"1\">SaMD can\u00a0operate\u00a0on general<span data-contrast=\"auto\">\u2011<\/span><span data-contrast=\"auto\">purpose computing platforms, meaning systems not originally designed for medical use.<\/span><\/li>\n<li data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"12\" 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;multilevel&quot;}\" data-aria-posinset=\"1\" data-aria-level=\"1\"><span data-contrast=\"auto\">SaMD <\/span>may be used in combination with other products<span data-contrast=\"auto\">, such as modules or components that interface with medical devices.<\/span><span data-ccp-props=\"{}\">\u00a0<\/span><\/li>\n<li data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"12\" 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;multilevel&quot;}\" data-aria-posinset=\"1\" data-aria-level=\"1\"><span data-contrast=\"auto\">SaMD may interact with other medical devices, hardware, other medical<\/span><span data-contrast=\"auto\">\u2011<\/span><span data-contrast=\"auto\">device software, or general<\/span><span data-contrast=\"auto\">\u2011<\/span><span data-contrast=\"auto\">purpose software.<\/span><span data-ccp-props=\"{}\">\u00a0<\/span><\/li>\n<li data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"12\" 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;multilevel&quot;}\" data-aria-posinset=\"1\" data-aria-level=\"1\"><span data-contrast=\"auto\">Mobile applications (apps) that meet this definition are also treated as SaMD in Costa Rica.<\/span><span data-ccp-props=\"{}\">\u00a0<\/span><\/li>\n<\/ul>\n<p><span data-ccp-props=\"{&quot;335559685&quot;:720}\">\u00a0<\/span><\/p>\n<h3><b><span data-contrast=\"auto\">Examples: What Qualifies (and What Doesn&#8217;t)<\/span><\/b><span data-ccp-props=\"{}\">\u00a0<\/span><\/h3>\n<p><span data-ccp-props=\"{}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">Although software is increasingly present in the medical ecosystem,\u00a0<\/span><b><span data-contrast=\"auto\">not all software used in healthcare settings is considered SaMD in Costa Rica<\/span><\/b><span data-contrast=\"auto\">. As in other\u00a0jurisdictions, the key determinant is\u00a0<\/span>intended\u00a0use.<\/p>\n<p><span data-ccp-props=\"{}\">\u00a0<\/span><\/p>\n<h5><span data-contrast=\"auto\">Software Considered SaMD<\/span><span data-ccp-props=\"{}\">\u00a0<\/span><\/h5>\n<p>&nbsp;<\/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;multilevel&quot;}\" data-aria-posinset=\"1\" data-aria-level=\"1\"><b><span data-contrast=\"auto\">Computer\u00a0aided detection (CAD)<\/span><\/b><span data-contrast=\"auto\">\u00a0software that\u00a0post-processes\u00a0medical images to detect certain pathologies or clearly defined clinical problems.<\/span><span data-ccp-props=\"{}\">\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;multilevel&quot;}\" data-aria-posinset=\"2\" data-aria-level=\"1\"><b><span data-contrast=\"auto\">Clinical data analysis tools<\/span><\/b><span data-contrast=\"auto\">\u00a0used to support diagnostic or therapeutic decisions.<\/span><span data-ccp-props=\"{}\">\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;multilevel&quot;}\" data-aria-posinset=\"3\" data-aria-level=\"1\"><b><span data-contrast=\"auto\">Diagnostic image viewers<\/span><\/b><span data-contrast=\"auto\">\u00a0for mobile devices used for clinical interpretation.<\/span><span data-ccp-props=\"{}\">\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;multilevel&quot;}\" data-aria-posinset=\"4\" data-aria-level=\"1\"><b><span data-contrast=\"auto\">Dosage Calculators:<\/span><\/b><span data-contrast=\"auto\">\u00a0Software that recommends drug dosages based on specific patient data.<\/span><span data-ccp-props=\"{}\">\u00a0<\/span><\/li>\n<\/ul>\n<ul>\n<li data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"6\" 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;multilevel&quot;}\" data-aria-posinset=\"1\" data-aria-level=\"1\"><b><span data-contrast=\"auto\">Telemedicine platforms<\/span><\/b><span data-contrast=\"auto\">\u00a0capable of receiving, analyzing, and displaying patients\u2019 physiological data with a clinical purpose.<\/span><span data-ccp-props=\"{}\">\u00a0<\/span><\/li>\n<\/ul>\n<p><span data-ccp-props=\"{}\">\u00a0<\/span><\/p>\n<p><span data-ccp-props=\"{}\">\u00a0<\/span><\/p>\n<h5><span data-contrast=\"auto\">Software NOT Considered SaMD<\/span><span data-ccp-props=\"{}\">\u00a0<\/span><\/h5>\n<p><span data-ccp-props=\"{}\">\u00a0<\/span><\/p>\n<ul>\n<li data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"13\" 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;multilevel&quot;}\" data-aria-posinset=\"1\" data-aria-level=\"1\"><b><span data-contrast=\"auto\">Maintenance Software:<\/span><\/b><span data-contrast=\"auto\">\u00a0applications displaying error codes or operational logs for a technician.<\/span><span data-ccp-props=\"{}\">\u00a0<\/span><\/li>\n<\/ul>\n<ul>\n<li data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"13\" 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;multilevel&quot;}\" data-aria-posinset=\"2\" data-aria-level=\"1\"><b><span data-contrast=\"auto\">Embedded Software (Firmware):<\/span><\/b><span data-contrast=\"auto\">\u00a0Software that\u00a0resides\u00a0within the hardware to make it function (e.g., the motor control of an infusion pump). This is regulated as part of the\u00a0medical device itself.<\/span><span data-ccp-props=\"{}\">\u00a0<\/span><\/li>\n<\/ul>\n<ul>\n<li data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"13\" 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;multilevel&quot;}\" data-aria-posinset=\"3\" data-aria-level=\"1\"><b><span data-contrast=\"auto\">Software required by a medical device to achieve its intended purpose.<\/span><\/b><br \/>\n<span data-contrast=\"auto\">Even when distributed separately, if the software is essential to the functioning of the physical EMB, it is not categorized as SaMD.<\/span><span data-ccp-props=\"{}\">\u00a0<\/span><\/li>\n<\/ul>\n<ul>\n<li data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"13\" 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;multilevel&quot;}\" data-aria-posinset=\"4\" data-aria-level=\"1\"><b><span data-contrast=\"auto\">Software that controls hardware components in medical devices.<\/span><\/b><br \/>\n<span data-contrast=\"auto\">For example, software that controls the motors of an infusion pump.<\/span><span data-ccp-props=\"{}\">\u00a0<\/span><\/li>\n<\/ul>\n<ul>\n<li data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"13\" 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;multilevel&quot;}\" data-aria-posinset=\"5\" data-aria-level=\"1\"><b><span data-contrast=\"auto\">Software that uses data from a medical device but does not have a medical purpose.<\/span><\/b><br \/>\n<span data-contrast=\"auto\">Datavisualization tools without diagnostic, monitoring, preventive, or therapeutic functions.<\/span><span data-ccp-props=\"{}\">\u00a0<\/span><\/li>\n<\/ul>\n<ul>\n<li data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"13\" 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;multilevel&quot;}\" data-aria-posinset=\"6\" data-aria-level=\"1\"><b><span data-contrast=\"auto\">Software designed for clinical communication and workflow.<\/span><\/b><br \/>\n<span data-contrast=\"auto\">Applications used for tasks such as patient registration, video calls, voice communication, scheduling, or administrative workflows.<\/span><span data-ccp-props=\"{}\">\u00a0<\/span><\/li>\n<\/ul>\n<ul>\n<li data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"13\" 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;multilevel&quot;}\" data-aria-posinset=\"7\" data-aria-level=\"1\"><b><span data-contrast=\"auto\">Educational Tools:<\/span><\/b><span data-contrast=\"auto\">\u00a0Platforms used solely for training healthcare providers.<\/span><span data-ccp-props=\"{}\">\u00a0<\/span><\/li>\n<\/ul>\n<p><span data-ccp-props=\"{}\"><br \/>\n<\/span><\/p>\n<h3><b><span data-contrast=\"auto\">Frequently\u00a0Asked\u00a0Questions\u00a0(FAQ)\u202f<\/span><\/b><span data-ccp-props=\"{}\">\u00a0<\/span><\/h3>\n<p><span data-ccp-props=\"{}\">\u00a0<\/span><\/p>\n<ol>\n<li><b><span data-contrast=\"auto\"> How do I know if my software qualifies as Software as a Medical Device (SaMD) in Costa Rica?<\/span><\/b><\/li>\n<\/ol>\n<p><span data-contrast=\"auto\">Your software is considered SaMD if it performs a\u00a0<\/span>medical purpose<span data-contrast=\"auto\">\u2014such as diagnosis, monitoring, prevention, treatment, or therapy\u2014<\/span>independently\u00a0of\u00a0medical\u00a0hardware<span data-contrast=\"auto\">. If its intended use contributes directly to a clinical decision or action, it\u00a0likely qualifies\u00a0as SaMD.<\/span><span data-ccp-props=\"{}\">\u00a0<\/span><\/p>\n<ol start=\"2\">\n<li><b><span data-contrast=\"auto\"> Does Costa Rica follow IMDRF principles for SaMD?<\/span><\/b><\/li>\n<\/ol>\n<p><span data-contrast=\"auto\">Yes. Decree No. 43902-S is designed to align Costa Rican standards with global IMDRF concepts to\u00a0facilitate\u00a0international trade and safety.<\/span><span data-ccp-props=\"{}\">\u00a0<\/span><\/p>\n<ol start=\"3\">\n<li><b><span data-contrast=\"auto\"> Are all health-related mobile appsconsidered SaMD in Costa Rica?<\/span><\/b><\/li>\n<\/ol>\n<p><span data-contrast=\"auto\">No. Only apps with a clinical purpose (monitoring, interpretation) are SaMD. Wellness trackers or &#8220;step counters&#8221;\u00a0generally do\u00a0not fall under this regulation.<\/span><span data-ccp-props=\"{}\">\u00a0<\/span><\/p>\n<ol start=\"4\">\n<li><b><span data-contrast=\"auto\"> Is embedded software (firmware) considered SaMD?<\/span><\/b><\/li>\n<\/ol>\n<p><span data-contrast=\"auto\">No. Software necessary for the functioning of physical\u00a0medical\u00a0device\u00a0hardware is regulated as part of the\u00a0device itself, not as SaMD.<\/span><span data-ccp-props=\"{}\">\u00a0<\/span><\/p>\n<p><span data-ccp-props=\"{}\">\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;335551550&quot;:0,&quot;335551620&quot;:0,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/h3>\n<p><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335551550&quot;:0,&quot;335551620&quot;:0,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">Determining\u00a0the distinction between SaMD and general medical software dictates your entire submission strategy. Accurate classification prevents timeline shifts and regulatory hurdles during the Ministry of Health review process.<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335551550&quot;:0,&quot;335551620&quot;:0,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">Partner with<\/span><b><span data-contrast=\"auto\">\u00a0<\/span><\/b><a href=\"mailto:contact@veraqueconsulting.com\"><b><span data-contrast=\"none\">Veraque<\/span><\/b><\/a><b><span data-contrast=\"auto\">\u00a0<\/span><\/b><span data-contrast=\"auto\">to streamline your SaMD registration in Costa Rica. We act as your on-the-ground regulatory department, helping you with any step of your strategy.\u00a0<\/span><span data-contrast=\"auto\">If\u00a0you are\u00a0just starting your research, you can explore\u00a0our\u00a0<\/span><a href=\"https:\/\/veraqueconsulting.com\/cr\/guides\/\" target=\"_blank\" rel=\"noopener\"><span data-contrast=\"none\">detailed regulatory guidelines here.<\/span><\/a><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335551550&quot;:0,&quot;335551620&quot;:0,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/p>\n","protected":false},"excerpt":{"rendered":"<p>As digital health transforms the landscape of patient care in Latin America, Costa Rica has solidified its stance on digital therapeutics and diagnostic tools. Navigating the registration of health technology requires a precise understanding of how the\u00a0Ministry of Health\u00a0categorizes digital solutions.\u00a0\u00a0 \u00a0 In Costa Rica, software is not just a &#8220;tool&#8221;,\u00a0under specific conditions, it is [&hellip;]<\/p>\n","protected":false},"author":6,"featured_media":3313,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[367,386],"tags":[],"class_list":["post-3312","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-classification","category-costa-rica"],"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>Software as a Medical Device (SaMD) in Costa Rica - Veraque Costa Rica<\/title>\n<meta name=\"description\" content=\"Navigate SaMD regulations in Costa Rica. 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