{"id":3344,"date":"2026-04-21T13:08:05","date_gmt":"2026-04-21T13:08:05","guid":{"rendered":"https:\/\/veraqueconsulting.com\/cr\/?p=3344"},"modified":"2026-04-21T13:08:05","modified_gmt":"2026-04-21T13:08:05","slug":"myoelectric-prostheses-classification-and-grouping-in-costa-rica","status":"publish","type":"post","link":"https:\/\/veraqueconsulting.com\/cr\/myoelectric-prostheses-classification-and-grouping-in-costa-rica\/","title":{"rendered":"Myoelectric Prostheses: Classification and Grouping in Costa Rica"},"content":{"rendered":"<p><span data-contrast=\"auto\">Myoelectric prostheses are medical devices developed to\u00a0assist\u00a0individuals with limb loss by enabling functional movement restoration. These systems capture electromyographic (EMG) signals from residual muscles to\u00a0operate\u00a0motorized components, providing greater precision and flexibility compared to traditional mechanical prostheses.<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;201341983&quot;:0,&quot;335559738&quot;:0,&quot;335559739&quot;:160,&quot;335559740&quot;:276}\">\u00a0<\/span><\/p>\n<p><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">In Costa Rica, oversight of medical devices\u00a0(including prosthetic technologies)\u00a0is managed by the Ministry of Health.\u00a0Manufacturers, distributors, and clinical professionals must navigate the country\u2019s regulatory framework to achieve market authorization and ensure compliance. By examining how myoelectric prostheses are classified and grouped under Costa Rican regulations, this\u00a0article\u00a0provides\u00a0practical\u00a0insights\u00a0to\u00a0introduce these technologies into the national healthcare system.<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/p>\n<p><span data-ccp-props=\"{}\">\u00a0<\/span><\/p>\n<h3><b><span data-contrast=\"auto\">Distinction by Risk Level and Technological Characteristics<\/span><\/b><span data-ccp-props=\"{}\">\u00a0<\/span><\/h3>\n<p><span data-ccp-props=\"{}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">Not all prosthetic devices are classified equally under the Ministry of Health. Their classification depends on the presence or absence of active components and the associated risk level.<\/span><span data-ccp-props=\"{}\">\u00a0<\/span><\/p>\n<p><span data-ccp-props=\"{&quot;335559731&quot;:708}\">\u00a0<\/span><\/p>\n<h5><i><span data-contrast=\"auto\">Passive and Cosmetic Prostheses: Non-Technological Designs<\/span><\/i><span data-ccp-props=\"{}\">\u00a0<\/span><\/h5>\n<p>&nbsp;<\/p>\n<p><span data-contrast=\"auto\">Passive prostheses do not rely on electrical or electronic mechanisms. They exist primarily to provide functional support or cosmetic restoration and are external, non\u2011invasive devices. Examples include:<\/span><span data-ccp-props=\"{&quot;335551550&quot;:6,&quot;335551620&quot;:6}\">\u00a0<\/span><\/p>\n<p><span data-ccp-props=\"{&quot;335551550&quot;:6,&quot;335551620&quot;:6}\">\u00a0<\/span><\/p>\n<ul>\n<li data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"26\" 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\">External limb prostheses for upper and lower extremities<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:0,&quot;335559739&quot;:0}\">\u00a0<\/span><\/li>\n<\/ul>\n<ul>\n<li data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"26\" 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\">Mechanical finger prostheses<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:0,&quot;335559739&quot;:0}\">\u00a0<\/span><\/li>\n<\/ul>\n<ul>\n<li data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"26\" 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\">Cosmetic shells or limb covers<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:0,&quot;335559739&quot;:0}\">\u00a0<\/span><\/li>\n<\/ul>\n<p><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559685&quot;:720,&quot;335559738&quot;:0,&quot;335559739&quot;:0}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">According to\u00a0Decree No. 43902-S,\u00a0these devices\u00a0qualify as\u00a0<\/span><b><span data-contrast=\"auto\">Class\u00a0I\u00a0<\/span><\/b><span data-contrast=\"auto\">provided they\u00a0are\u00a0non\u2011invasive devices\u00a0and\u00a0do not contact injured skin or connect to an active device.<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/p>\n<p>&nbsp;<\/p>\n<h5><i><span data-contrast=\"auto\">Technologically Enhanced Prostheses: Powered and Signal-Responsive Systems<\/span><\/i><span data-ccp-props=\"{}\">\u00a0<\/span><\/h5>\n<p><span data-ccp-props=\"{}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">Medical systems that incorporate EMG sensors, batteries, microprocessors, or motors are\u00a0categorized as\u00a0active devices. Myoelectric prostheses fall\u00a0within this classification. These technologies convert biological signals into controlled mechanical motion and therefore administer energy to the body through powered components.\u00a0As\u00a0a result, they are subject to a higher regulatory classification compared to non\u2011powered prosthetic devices.<\/span><span data-ccp-props=\"{}\">\u00a0<\/span><\/p>\n<p><span data-ccp-props=\"{}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">Associated\u00a0risks\u00a0include:<\/span><span data-ccp-props=\"{}\">\u00a0<\/span><\/p>\n<ul>\n<li data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"11\" 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\">Battery\u00a0overheating,\u00a0leakage,\u00a0or\u00a0failure\u00a0<\/span><span data-ccp-props=\"{}\">\u00a0<\/span><\/li>\n<\/ul>\n<ul>\n<li data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"11\" 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\"><span data-contrast=\"auto\">Electrode\u00a0malfunction\u00a0or\u00a0skin\u00a0irritation\u00a0<\/span><span data-ccp-props=\"{}\">\u00a0<\/span><\/li>\n<\/ul>\n<ul>\n<li data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"11\" 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\"><span data-contrast=\"auto\">Signal\u00a0misinterpretation\u00a0affecting\u00a0movement\u00a0control\u00a0<\/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<h3><b><span data-contrast=\"auto\">Classification of Prosthetic Devices under\u00a0the Ministry of Health\u00a0<\/span><\/b><span data-ccp-props=\"{}\">\u00a0<\/span><\/h3>\n<p><span data-ccp-props=\"{}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">Costa Rica\u2019s classification system evaluates devices based on technological complexity, intended use, and interaction with the user. In this context:<\/span><span data-ccp-props=\"{}\">\u00a0<\/span><\/p>\n<ul>\n<li data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"27\" 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\"><b><span data-contrast=\"auto\">Class 1:\u00a0<\/span><\/b><span data-contrast=\"auto\">Passive, external prostheses that do not involve powered systems and do not fall under skin\u2011injury or special\u2011case categories.\u00a0<\/span><span data-ccp-props=\"{}\">\u00a0<\/span><\/li>\n<\/ul>\n<ul>\n<li data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"27\" 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\"><b><span data-contrast=\"auto\">Class 2:\u00a0<\/span><\/b><span data-contrast=\"auto\">\u00a0Active\u00a0therapeutic prostheses such as myoelectric systems. These devices administer energy to the user and require demonstration of operational safety, electromagnetic compatibility, and performance reliability.<\/span><span data-ccp-props=\"{}\">\u00a0<\/span><\/li>\n<\/ul>\n<p><span data-ccp-props=\"{}\">\u00a0<\/span><\/p>\n<h3><b><span data-contrast=\"auto\">Myoelectric Prostheses Grouping Strategies in Costa Rica<\/span><\/b><\/h3>\n<p>&nbsp;<\/p>\n<p><span data-contrast=\"auto\">Myoelectric prosthesis models may be grouped when they originate from the same manufacturer and meet the criteria\u00a0established\u00a0in\u00a0<\/span><b><span data-contrast=\"auto\">Decree N\u00b0 43902\u2011S<\/span><\/b><span data-contrast=\"auto\">. Grouping is\u00a0generally\u00a0permitted\u00a0when differences between models are non\u2011substantial. In practice, this can include variations such as:<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/p>\n<ul>\n<li data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"28\" 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\">Socket size adjustments\u00a0to accommodate different patient anatomies.<\/li>\n<\/ul>\n<ul>\n<li data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"28\" 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\">Cosmetic coverings or external housings\u00a0with alternative shapes or finishes.<\/li>\n<\/ul>\n<ul>\n<li data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"28\" 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\">Minor\u00a0differences\u00a0<span data-contrast=\"auto\">that\u00a0do not alter the underlying EMG\u2011controlled functionality.<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:0,&quot;335559739&quot;:0}\">\u00a0<\/span><\/li>\n<\/ul>\n<p><span data-contrast=\"auto\">These types of modifications allow devices to be classified within an\u00a0<\/span><a href=\"https:\/\/veraqueconsulting.com\/cr\/guides\/classification-and-grouping-ultimate-guide\/#grouping\">EMB family<\/a><span data-contrast=\"auto\">, since the core technology and performance remain consistent.<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/p>\n<p>&nbsp;<\/p>\n<h3><b><span data-contrast=\"auto\">Conclusion<\/span><\/b><span data-ccp-props=\"{}\">\u00a0<\/span><\/h3>\n<p>&nbsp;<\/p>\n<p>Costa Rica\u2019s regulatory framework for prosthetic technologies reflects a careful balance between patient safety and technological advancement. By distinguishing devices according to risk level and technological complexity, the Ministry of Health ensures that passive prostheses remain accessible while myoelectric systems undergo evaluation to guarantee reliability and performance.<\/p>\n<p><span data-contrast=\"auto\">For guidance on the registration of prosthetic devices or other medical technologies in the Colombian market, you can reach us at\u00a0<\/span><a href=\"mailto:contact@veraqueconsulting.com\"><b><span data-contrast=\"none\">contact@veraqueconsulting.com<\/span><\/b><\/a><span data-contrast=\"auto\">\u00a0or consult\u00a0our\u00a0<\/span><a href=\"https:\/\/veraqueconsulting.com\/cr\/guides\/\" target=\"_blank\" rel=\"noopener\"><span data-contrast=\"none\">guidelines<\/span><\/a><span data-contrast=\"auto\">.<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Myoelectric prostheses are medical devices developed to\u00a0assist\u00a0individuals with limb loss by enabling functional movement restoration. These systems capture electromyographic (EMG) signals from residual muscles to\u00a0operate\u00a0motorized components, providing greater precision and flexibility compared to traditional mechanical prostheses.\u00a0 \u00a0 In Costa Rica, oversight of medical devices\u00a0(including prosthetic technologies)\u00a0is managed by the Ministry of Health.\u00a0Manufacturers, distributors, and clinical [&hellip;]<\/p>\n","protected":false},"author":6,"featured_media":3345,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[367,386],"tags":[],"class_list":["post-3344","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>Myoelectric Prostheses: Classification and 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