{"id":1422,"date":"2021-02-23T17:23:52","date_gmt":"2021-02-23T17:23:52","guid":{"rendered":"https:\/\/veraqueconsulting.com\/cr\/?page_id=1422"},"modified":"2025-04-07T17:19:47","modified_gmt":"2025-04-07T17:19:47","slug":"classification-and-grouping-ultimate-guide","status":"publish","type":"page","link":"https:\/\/veraqueconsulting.com\/cr\/guides\/classification-and-grouping-ultimate-guide\/","title":{"rendered":"Classification and Grouping Ultimate Guide"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-page\" data-elementor-id=\"1422\" class=\"elementor elementor-1422\" data-elementor-post-type=\"page\">\n\t\t\t\t\t\t<header class=\"elementor-section elementor-top-section elementor-element elementor-element-710f6ad elementor-section-full_width elementor-section-height-default elementor-section-height-default\" data-id=\"710f6ad\" data-element_type=\"section\" data-e-type=\"section\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;,&quot;sticky&quot;:&quot;top&quot;,&quot;sticky_on&quot;:[&quot;desktop&quot;,&quot;tablet&quot;,&quot;mobile&quot;],&quot;sticky_offset&quot;:0,&quot;sticky_effects_offset&quot;:0,&quot;sticky_anchor_link_offset&quot;:0}\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-50 elementor-top-column elementor-element elementor-element-bf34b9b\" data-id=\"bf34b9b\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-ca7ef60 elementor-widget elementor-widget-image\" data-id=\"ca7ef60\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"image.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<a href=\"https:\/\/veraqueconsulting.com\/cr\" target=\"_blank\">\n\t\t\t\t\t\t\t<img decoding=\"async\" width=\"300\" height=\"70\" src=\"https:\/\/veraqueconsulting.com\/cr\/wp-content\/uploads\/sites\/5\/2019\/11\/logo-300x70.png\" class=\"attachment-medium size-medium wp-image-22\" alt=\"\" srcset=\"https:\/\/veraqueconsulting.com\/cr\/wp-content\/uploads\/sites\/5\/2019\/11\/logo-300x70.png 300w, https:\/\/veraqueconsulting.com\/cr\/wp-content\/uploads\/sites\/5\/2019\/11\/logo.png 450w\" sizes=\"(max-width: 300px) 100vw, 300px\" \/>\t\t\t\t\t\t\t\t<\/a>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t<div class=\"elementor-column elementor-col-50 elementor-top-column elementor-element elementor-element-d047ed4\" data-id=\"d047ed4\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap\">\n\t\t\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/header>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-17d98cc elementor-section-full_width elementor-section-height-default elementor-section-height-default\" data-id=\"17d98cc\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-50 elementor-top-column elementor-element elementor-element-34a3b10\" data-id=\"34a3b10\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-e50a7b8 elementor-widget elementor-widget-heading\" data-id=\"e50a7b8\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h1 class=\"elementor-heading-title elementor-size-default\">DEVICE CLASSIFICATION AND DEVICE GROUPING<\/h1>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-fa852e5 elementor-widget elementor-widget-text-editor\" data-id=\"fa852e5\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>In Costa Rica, the Ministry of Health (MoH) is the entity in charge of developing the laws and regulations for medical devices or EMB (Equipment and Biomedical Material) \u2013both terms are considered synonymous in this document and used interchangeably. The classification of such devices or EMBs is designated based on the level of risk and results in 4 classifications (class I, II, III and IV) based on Chapter II of the Official Decree 43902-S. In this guideline, we will summarize the referred regulation to correctly classify and group a medical device in Costa Rica.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t<div class=\"elementor-column elementor-col-50 elementor-top-column elementor-element elementor-element-7cd42cc\" data-id=\"7cd42cc\" data-element_type=\"column\" data-e-type=\"column\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-1f91973 elementor-widget elementor-widget-spacer\" data-id=\"1f91973\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"spacer.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-spacer\">\n\t\t\t<div class=\"elementor-spacer-inner\"><\/div>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-1890e98 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"1890e98\" data-element_type=\"section\" data-e-type=\"section\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-f4d72b3\" data-id=\"f4d72b3\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-135aee9 elementor-widget elementor-widget-menu-anchor\" data-id=\"135aee9\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"menu-anchor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-menu-anchor\" id=\"medical\"><\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-1c249de elementor-widget elementor-widget-image\" data-id=\"1c249de\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"image.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<img fetchpriority=\"high\" decoding=\"async\" width=\"800\" height=\"800\" src=\"https:\/\/veraqueconsulting.com\/cr\/wp-content\/uploads\/sites\/5\/2020\/01\/medical-equipment.svg\" class=\"attachment-large size-large wp-image-322\" alt=\"\" srcset=\"https:\/\/veraqueconsulting.com\/cr\/wp-content\/uploads\/sites\/5\/\/2020\/01\/medical-equipment.svg 150w, https:\/\/veraqueconsulting.com\/cr\/wp-content\/uploads\/sites\/5\/\/2020\/01\/medical-equipment.svg 300w, https:\/\/veraqueconsulting.com\/cr\/wp-content\/uploads\/sites\/5\/\/2020\/01\/medical-equipment.svg 1024w\" sizes=\"(max-width: 800px) 100vw, 800px\" \/>\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-f892502 elementor-widget elementor-widget-heading\" data-id=\"f892502\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Non-medical devices and unregulated devices<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-7e33673 elementor-widget elementor-widget-text-editor\" data-id=\"7e33673\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>As mentioned, the decree No. 43902-S details the classification rules. In the Annex 1 of this document, 62 class I listed devices are exempted from a regulatory process, including the registration. As we will further explain, after the publication of these 62 unregulated products, the Ministry of Health stated that if a medical device is considered as class I, a sanitary registration is not required, even if it is not mentioned in Annex 1. However, a proper classification is a very important aspect to ensure that it belongs to this category. Otherwise, a product that requires a sanitary registration may end up illegally commercializing in the country.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-cd8c6b9 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"cd8c6b9\" data-element_type=\"section\" data-e-type=\"section\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-dd5ba6d\" data-id=\"dd5ba6d\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-c2eb238 elementor-widget elementor-widget-menu-anchor\" data-id=\"c2eb238\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"menu-anchor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-menu-anchor\" id=\"devices\"><\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-46cff8a elementor-widget elementor-widget-image\" data-id=\"46cff8a\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"image.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<img decoding=\"async\" width=\"800\" height=\"800\" src=\"https:\/\/veraqueconsulting.com\/cr\/wp-content\/uploads\/sites\/5\/2020\/01\/surgical-instr.svg\" class=\"attachment-large size-large wp-image-320\" alt=\"\" srcset=\"https:\/\/veraqueconsulting.com\/cr\/wp-content\/uploads\/sites\/5\/\/2020\/01\/surgical-instr.svg 150w, https:\/\/veraqueconsulting.com\/cr\/wp-content\/uploads\/sites\/5\/\/2020\/01\/surgical-instr.svg 300w, https:\/\/veraqueconsulting.com\/cr\/wp-content\/uploads\/sites\/5\/\/2020\/01\/surgical-instr.svg 1024w, https:\/\/veraqueconsulting.com\/cr\/wp-content\/uploads\/sites\/5\/\/2020\/01\/surgical-instr.svg 48w\" sizes=\"(max-width: 800px) 100vw, 800px\" \/>\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-c7b88eb elementor-widget elementor-widget-heading\" data-id=\"c7b88eb\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\"> Medical Devices<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-b388a06 elementor-widget elementor-widget-text-editor\" data-id=\"b388a06\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>We have mentioned a list of 62 unregulated devices and that any class I medical device is also exempted of a sanitary registration. Nevertheless, it is important to have a better idea of each medical device class description to identify which products are unregulated (class I or a non-medical device) or regulated (class II, III or IV).<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-6376441 elementor-widget elementor-widget-text-editor\" data-id=\"6376441\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p><b>Class I EMB<\/b><\/p><ul><li aria-level=\"1\">Non-invasive EMB in direct contact with wounded mucosa or skin.<\/li><li aria-level=\"1\">Invasive EMB that enter into the body through a natural orifice.<\/li><li aria-level=\"1\">Invasive but not surgical EMB, not connected to active medical equipment (those related with a power source).<\/li><li aria-level=\"1\">Surgical or dental reusable instrument.<\/li><\/ul><p>Wound dressings, nasal or oropharyngeal cannulas and reusable instruments used by surgeons are typical examples of this class.\u00a0\u00a0<\/p><p>Class I devices are no longer registered per regulation N\u00b0 41387-S issued on November 26, 2018.<\/p><p>\u00a0<\/p><p><b>Class II EMB<\/b><\/p><ul><li aria-level=\"1\">Invasive EMB that enter into the body through a natural orifice.<\/li><li aria-level=\"1\">Any EMB intended to be in direct contact with the eye surface.<\/li><li aria-level=\"1\">Non-invasive EMB destined to contain or to lead gases, liquids or corporal fluids to be introduced to the body.<\/li><li aria-level=\"1\">Non-invasive EMB designed to modify the blood biological and\/or chemical composition.<\/li><li aria-level=\"1\">Surgically invasive EMB.<\/li><li aria-level=\"1\">Non-invasive EMB connected to an active medical device (those related with a power source).<\/li><li aria-level=\"1\">An active EMB used to clean and sterilize another device.<\/li><li aria-level=\"1\">Active EMB intended for diagnostic or monitoring procedures.\u00a0<\/li><li aria-level=\"1\">Personal use IVD (In Vitro Diagnostic) tests to detect pregnancy, fertility, glucose or cholesterol levels<\/li><li aria-level=\"1\">Sponge-type contraceptive devices, diaphragms and their insertion devices.<\/li><\/ul><p>Some common medical devices located in Class II are: eye contact lenses, probes for endoscopy, ultrasound systems, hypodermic needles and pregnancy tests<span style=\"font-weight: 400;\">.<\/span><\/p><p>\u00a0<\/p><p><span style=\"font-weight: 400;\">Class III EMB<\/span><\/p><ul><li aria-level=\"1\">Invasive and surgical EMB that will remain inside the body for a period of 30 days or more.<\/li><li aria-level=\"1\">Non-latex or non-natural membrane condoms.<\/li><li aria-level=\"1\">Intrauterine devices and their insertion devices used in contraception.<\/li><li aria-level=\"1\">Active EMB (those related to a power source) intended to evaluate a disease and from which an error in the result may cause immediate threat to the patient\u2019s health.<\/li><li aria-level=\"1\">Active EMB used in therapy to deliver or exchange energy to the patient\u2019s body.\u00a0<\/li><li aria-level=\"1\">IVD (In Vitro Diagnostic) equipment, which is used for tests whose erroneous result can cause death or severe damage.<\/li><li aria-level=\"1\">Active EMB used to emit ionizing radiation.<\/li><\/ul><p>Surgical sutures, orthopedic implants and X-ray equipment are a good example of Class III EMB.<\/p><p>\u00a0<\/p><p><span style=\"font-weight: 400;\">Class IV EMB<\/span><\/p><ul><li aria-level=\"1\">Natural membrane condoms.<\/li><li aria-level=\"1\">Invasive and surgical EMB used to diagnose, monitor, control, or correct a defect of the central cardiovascular system or the central nervous system.<\/li><li aria-level=\"1\">EMBs used to disinfect or sterilize organs to be transplanted.<\/li><li aria-level=\"1\">EMB (except for IVDs) that incorporate in their manufacture an animal source, or products obtained through the use of recombinant DNA technology.<\/li><li aria-level=\"1\">Breast prostheses and tissue extenders for breast prostheses.<\/li><li aria-level=\"1\">IVDs to detect the presence of sexually transmitted agents: HIV, HLTCV, HBV, HCV and HDV<span style=\"font-weight: 400;\">.<\/span><\/li><\/ul><p>Cardiac bypass and cerebrospinal valves are examples of class IV EMB.\u00a0<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-8f09c88 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"8f09c88\" data-element_type=\"section\" data-e-type=\"section\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-c87a102\" data-id=\"c87a102\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-8348331 elementor-widget elementor-widget-menu-anchor\" data-id=\"8348331\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"menu-anchor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-menu-anchor\" id=\"grouping\"><\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-6c10205 elementor-widget elementor-widget-image\" data-id=\"6c10205\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"image.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<img loading=\"lazy\" decoding=\"async\" width=\"800\" height=\"800\" src=\"https:\/\/veraqueconsulting.com\/cr\/wp-content\/uploads\/sites\/5\/2020\/01\/grouping.svg\" class=\"attachment-large size-large wp-image-317\" alt=\"\" srcset=\"https:\/\/veraqueconsulting.com\/cr\/wp-content\/uploads\/sites\/5\/\/2020\/01\/grouping.svg 150w, https:\/\/veraqueconsulting.com\/cr\/wp-content\/uploads\/sites\/5\/\/2020\/01\/grouping.svg 300w, https:\/\/veraqueconsulting.com\/cr\/wp-content\/uploads\/sites\/5\/\/2020\/01\/grouping.svg 1024w\" sizes=\"(max-width: 800px) 100vw, 800px\" \/>\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-2b2ea91 elementor-widget elementor-widget-heading\" data-id=\"2b2ea91\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">DEVICE GROUPING <\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-180318b elementor-widget elementor-widget-text-editor\" data-id=\"180318b\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>Once the classification is defined, another crucial topic to consider is the grouping. Appropriate grouping criteria will allow us to group multiple devices in a single application. Nevertheless, there are certain concepts that are worth knowing to properly group a medical device. Specifically:<\/p><p>EMB family: Set of EMB\u2019s that have been made by the same manufacturer, have the same design and manufacturing process, are used for the same purpose and only differ in shape, color, taste, or size.<br \/>EMB group: It comprises a collection of EMBs that are presented for commercialization together to be used in a specific procedure. Its components may differ from each other and can be made by different manufacturers.<br \/>EMB group family: This is a collection of EMB groups that are made by the same manufacturer, have the same generic name, specific use, and differ only in the number and combination of products that each group contains.<br \/>Test kit: consists of reagents or items, or some combination of these, that will be used together to perform a specific test. This does not include the instruments necessary to carry out the test. The components of a kit are subject to the same registration, although these can be sold separately as a replacement for the mentioned kit.<br \/>Test kit family: This is a collection of test kits that are made by the same manufacturer, have the same generic name, specific use, and belong to the same diagnostic area.<\/p><p>The Ministry will grant a single registration to each EMB family, EMB group, EMB group family, test kit family or test kits. In addition, the Ministry of Health will assign a unique registration number to the group but an alphanumeric code to identify each member of the group. <br \/>If it is desired to include or change another member of the family or component of the system, a modification request must be submitted to the Ministry of Health through an official application signed by the responsible registrant.<br \/>As expected, and in all cases, a single registration will involve a single payment.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-c88c2cf elementor-hidden-tablet elementor-hidden-mobile elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"c88c2cf\" data-element_type=\"section\" data-e-type=\"section\" data-settings=\"{&quot;sticky&quot;:&quot;bottom&quot;,&quot;background_background&quot;:&quot;classic&quot;,&quot;sticky_effects_offset&quot;:600,&quot;sticky_on&quot;:[&quot;desktop&quot;],&quot;sticky_offset&quot;:0,&quot;sticky_anchor_link_offset&quot;:0}\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"make-column-clickable-elementor elementor-column elementor-col-33 elementor-top-column elementor-element elementor-element-6a0d29e\" style=\"cursor: pointer;\" data-column-clickable=\"#medical-device\" data-column-clickable-blank=\"_self\" data-id=\"6a0d29e\" data-element_type=\"column\" data-e-type=\"column\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-d68b24e elementor-position-inline-start elementor-view-default elementor-mobile-position-block-start elementor-widget elementor-widget-icon-box\" data-id=\"d68b24e\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"icon-box.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-icon-box-wrapper\">\n\n\t\t\t\t\t\t<div class=\"elementor-icon-box-icon\">\n\t\t\t\t<a href=\"#medical\" class=\"elementor-icon\" tabindex=\"-1\" aria-label=\"Non-medical devices and unregulated devices\">\n\t\t\t\t<svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" id=\"Layer_1\" data-name=\"Layer 1\" viewBox=\"0 0 62.2 59.7\"><defs><style>.cls-1{fill:url(#linear-gradient);}.cls-2{fill:url(#linear-gradient-2);}.cls-3{fill:url(#linear-gradient-5);}.cls-4{fill:url(#linear-gradient-6);}<\/style><linearGradient id=\"linear-gradient\" x1=\"458.5\" y1=\"604\" x2=\"458.5\" y2=\"659.33\" gradientUnits=\"userSpaceOnUse\"><stop offset=\"0.2\" stop-color=\"#ffc16f\"><\/stop><stop offset=\"0.63\" stop-color=\"#ff726f\"><\/stop><\/linearGradient><linearGradient id=\"linear-gradient-2\" x1=\"434.2\" y1=\"604\" x2=\"434.2\" y2=\"659.33\" xlink:href=\"#linear-gradient\"><\/linearGradient><linearGradient id=\"linear-gradient-5\" x1=\"443.25\" y1=\"604\" x2=\"443.25\" y2=\"659.33\" xlink:href=\"#linear-gradient\"><\/linearGradient><linearGradient id=\"linear-gradient-6\" x1=\"448.3\" y1=\"604\" x2=\"448.3\" y2=\"659.33\" xlink:href=\"#linear-gradient\"><\/linearGradient><\/defs><title>medical-equipment<\/title><path class=\"cls-1\" 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d=\"M444.3,640.4a2.65,2.65,0,0,0,2.6-2.6V623.2a2.65,2.65,0,0,0-2.6-2.6h-2.1a2.65,2.65,0,0,0-2.6,2.6v14.6a2.65,2.65,0,0,0,2.6,2.6h2.1Zm-2.8-2.6v-6.4h1.1a0.9,0.9,0,0,0,0-1.8h-1.1v-6.4a0.68,0.68,0,0,1,.7-0.7h2.1a0.68,0.68,0,0,1,.7.7v2.1h-1a0.9,0.9,0,0,0,0,1.8h1.1v7H444a0.9,0.9,0,0,0,0,1.8h1.1v1.8a0.68,0.68,0,0,1-.7.7h-2.1A0.61,0.61,0,0,1,441.5,637.8Z\" transform=\"translate(-427.4 -593.8)\"><\/path><path class=\"cls-4\" d=\"M437,604.7a1.16,1.16,0,0,0,.2,1,14,14,0,0,0,11.1,5.9h0a14.12,14.12,0,0,0,11.1-5.9,1.23,1.23,0,0,0,.2-1,1.46,1.46,0,0,0-.6-0.9c-2.2-1.5-4-2.7-5.6-3.9a1.55,1.55,0,0,0-2.1.3,3.66,3.66,0,0,1-3,1.6,4.27,4.27,0,0,1-3-1.6,1.46,1.46,0,0,0-2.1-.3c-1.6,1.2-3.4,2.4-5.6,3.9A1.8,1.8,0,0,0,437,604.7Zm15.8-3.4h0Zm-8.7.3a5.91,5.91,0,0,0,4.2,2.1h0.1a5.56,5.56,0,0,0,4.2-2.1c1.5,1.1,3.1,2.2,5,3.5a11.55,11.55,0,0,1-18.6,0C441,603.8,442.6,602.7,444.1,601.6Z\" transform=\"translate(-427.4 -593.8)\"><\/path><\/svg>\t\t\t\t<\/a>\n\t\t\t<\/div>\n\t\t\t\n\t\t\t\t\t\t<div class=\"elementor-icon-box-content\">\n\n\t\t\t\t\t\t\t\t\t<h3 class=\"elementor-icon-box-title\">\n\t\t\t\t\t\t<a href=\"#medical\" >\n\t\t\t\t\t\t\tNon-medical devices and unregulated devices\t\t\t\t\t\t<\/a>\n\t\t\t\t\t<\/h3>\n\t\t\t\t\n\t\t\t\t\n\t\t\t<\/div>\n\t\t\t\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t<div class=\"make-column-clickable-elementor elementor-column elementor-col-33 elementor-top-column elementor-element elementor-element-8edf386\" style=\"cursor: pointer;\" data-column-clickable=\"#grouping\" data-column-clickable-blank=\"_self\" data-id=\"8edf386\" data-element_type=\"column\" data-e-type=\"column\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-e7e7ad7 elementor-position-inline-start elementor-view-default elementor-mobile-position-block-start elementor-widget elementor-widget-icon-box\" data-id=\"e7e7ad7\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"icon-box.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-icon-box-wrapper\">\n\n\t\t\t\t\t\t<div class=\"elementor-icon-box-icon\">\n\t\t\t\t<a href=\"#devices\" class=\"elementor-icon\" tabindex=\"-1\" aria-label=\" Medical Devices\">\n\t\t\t\t<svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" id=\"Layer_1\" data-name=\"Layer 1\" viewBox=\"0 0 48.46 48.9\"><defs><style>.cls-1{fill:url(#linear-gradient);}.cls-2{fill:url(#linear-gradient-2);}.cls-3{fill:url(#linear-gradient-3);}.cls-4{fill:url(#linear-gradient-4);}.cls-5{fill:url(#linear-gradient-5);}<\/style><linearGradient id=\"linear-gradient\" x1=\"323.15\" y1=\"598.75\" x2=\"323.15\" y2=\"651.51\" gradientUnits=\"userSpaceOnUse\"><stop offset=\"0.2\" stop-color=\"#ffc16f\"><\/stop><stop offset=\"0.63\" stop-color=\"#ff726f\"><\/stop><\/linearGradient><linearGradient id=\"linear-gradient-2\" x1=\"323.2\" y1=\"598.75\" x2=\"323.2\" y2=\"651.51\" xlink:href=\"#linear-gradient\"><\/linearGradient><linearGradient id=\"linear-gradient-3\" x1=\"296.88\" y1=\"598.75\" x2=\"296.88\" y2=\"651.51\" xlink:href=\"#linear-gradient\"><\/linearGradient><linearGradient id=\"linear-gradient-4\" x1=\"309\" y1=\"598.75\" x2=\"309\" y2=\"651.51\" xlink:href=\"#linear-gradient\"><\/linearGradient><linearGradient id=\"linear-gradient-5\" x1=\"284.16\" y1=\"598.75\" x2=\"284.16\" y2=\"651.51\" xlink:href=\"#linear-gradient\"><\/linearGradient><\/defs><title>surgical-instr<\/title><path class=\"cls-1\" 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transform=\"translate(-278.74 -599.3)\"><\/path><path class=\"cls-4\" d=\"M310.3,641.2a0.88,0.88,0,0,0-.5,1,0.79,0.79,0,1,1-1.5.5,0.64,0.64,0,0,1,0-.6,1,1,0,0,1,.5-0.4,0.63,0.63,0,0,0,.5-0.6,0.83,0.83,0,0,0-.3-0.8,0.75,0.75,0,0,0-.8-0.1,2.44,2.44,0,1,0,3.1,1.5A0.67,0.67,0,0,0,310.3,641.2Z\" transform=\"translate(-278.74 -599.3)\"><\/path><path class=\"cls-5\" d=\"M285.9,642.3a0.64,0.64,0,0,0-.6,0,1,1,0,0,0-.4.5,0.79,0.79,0,0,1-1.5-.5,0.83,0.83,0,0,1,1-.5,1.06,1.06,0,0,0,.8-0.1,1.14,1.14,0,0,0,.3-0.8,1,1,0,0,0-.5-0.6,2.44,2.44,0,1,0,1.5,3.1,0.64,0.64,0,0,0,0-.6A1.18,1.18,0,0,0,285.9,642.3Z\" transform=\"translate(-278.74 -599.3)\"><\/path><\/svg>\t\t\t\t<\/a>\n\t\t\t<\/div>\n\t\t\t\n\t\t\t\t\t\t<div class=\"elementor-icon-box-content\">\n\n\t\t\t\t\t\t\t\t\t<h3 class=\"elementor-icon-box-title\">\n\t\t\t\t\t\t<a href=\"#devices\" >\n\t\t\t\t\t\t\t Medical Devices\t\t\t\t\t\t<\/a>\n\t\t\t\t\t<\/h3>\n\t\t\t\t\n\t\t\t\t\n\t\t\t<\/div>\n\t\t\t\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t<div class=\"make-column-clickable-elementor elementor-column elementor-col-33 elementor-top-column elementor-element elementor-element-d96b8d6\" style=\"cursor: pointer;\" data-column-clickable=\"#invitro\" data-column-clickable-blank=\"_self\" data-id=\"d96b8d6\" data-element_type=\"column\" data-e-type=\"column\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-3d98a40 elementor-position-inline-start elementor-view-default elementor-mobile-position-block-start elementor-widget elementor-widget-icon-box\" data-id=\"3d98a40\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"icon-box.default\">\n\t\t\t\t<div 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xlink:href=\"#linear-gradient\"><\/linearGradient><linearGradient id=\"linear-gradient-13\" x1=\"162.25\" y1=\"601.5\" x2=\"162.25\" y2=\"651.03\" xlink:href=\"#linear-gradient\"><\/linearGradient><linearGradient id=\"linear-gradient-14\" x1=\"21.4\" y1=\"5.7\" x2=\"21.4\" y2=\"55.23\" xlink:href=\"#linear-gradient\"><\/linearGradient><linearGradient id=\"linear-gradient-15\" x1=\"26.2\" y1=\"5.7\" x2=\"26.2\" y2=\"55.23\" xlink:href=\"#linear-gradient\"><\/linearGradient><linearGradient id=\"linear-gradient-18\" x1=\"179.55\" y1=\"601.5\" x2=\"179.55\" y2=\"651.03\" xlink:href=\"#linear-gradient\"><\/linearGradient><linearGradient id=\"linear-gradient-19\" x1=\"177.35\" y1=\"601.5\" x2=\"177.35\" y2=\"651.03\" xlink:href=\"#linear-gradient\"><\/linearGradient><linearGradient id=\"linear-gradient-20\" x1=\"181.75\" y1=\"601.5\" x2=\"181.75\" y2=\"651.03\" xlink:href=\"#linear-gradient\"><\/linearGradient><\/defs><title>grouping<\/title><path class=\"cls-1\" 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transform=\"translate(-138.5 -595.8)\"><\/path><polygon class=\"cls-11\" points=\"21.4 3 23 5.7 19.8 5.7 21.4 3\"><\/polygon><polygon class=\"cls-12\" points=\"26.2 3 27.8 5.7 24.6 5.7 26.2 3\"><\/polygon><polygon class=\"cls-11\" points=\"21.4 7.2 23 10 19.8 10 21.4 7.2\"><\/polygon><polygon class=\"cls-12\" points=\"26.2 7.2 27.8 10 24.6 10 26.2 7.2\"><\/polygon><path class=\"cls-13\" d=\"M183.5,608.9h-7.9a2.58,2.58,0,0,1-2.6-2.6v-7.9a2.58,2.58,0,0,1,2.6-2.6h7.9a2.58,2.58,0,0,1,2.6,2.6v7.9A2.58,2.58,0,0,1,183.5,608.9ZM175.6,597a1.32,1.32,0,0,0-1.3,1.3v7.9a1.32,1.32,0,0,0,1.3,1.3h7.9a1.32,1.32,0,0,0,1.3-1.3v-7.9a1.32,1.32,0,0,0-1.3-1.3h-7.9Z\" transform=\"translate(-138.5 -595.8)\"><\/path><path class=\"cls-14\" d=\"M178.1,601.5h-1.5a0.47,0.47,0,0,1-.5-0.5v-1.5a0.47,0.47,0,0,1,.5-0.5h1.5a0.47,0.47,0,0,1,.5.5V601A0.47,0.47,0,0,1,178.1,601.5Z\" transform=\"translate(-138.5 -595.8)\"><\/path><path class=\"cls-15\" d=\"M182.5,601.5H181a0.47,0.47,0,0,1-.5-0.5v-1.5a0.47,0.47,0,0,1,.5-0.5h1.5a0.47,0.47,0,0,1,.5.5V601A0.47,0.47,0,0,1,182.5,601.5Z\" transform=\"translate(-138.5 -595.8)\"><\/path><path class=\"cls-14\" d=\"M178.1,605.6h-1.5a0.47,0.47,0,0,1-.5-0.5v-1.5a0.47,0.47,0,0,1,.5-0.5h1.5a0.47,0.47,0,0,1,.5.5v1.5A0.47,0.47,0,0,1,178.1,605.6Z\" transform=\"translate(-138.5 -595.8)\"><\/path><path class=\"cls-15\" d=\"M182.5,605.6H181a0.47,0.47,0,0,1-.5-0.5v-1.5a0.47,0.47,0,0,1,.5-0.5h1.5a0.47,0.47,0,0,1,.5.5v1.5A0.47,0.47,0,0,1,182.5,605.6Z\" transform=\"translate(-138.5 -595.8)\"><\/path><\/svg>\t\t\t\t<\/a>\n\t\t\t<\/div>\n\t\t\t\n\t\t\t\t\t\t<div class=\"elementor-icon-box-content\">\n\n\t\t\t\t\t\t\t\t\t<h3 class=\"elementor-icon-box-title\">\n\t\t\t\t\t\t<a href=\"#grouping\" >\n\t\t\t\t\t\t\tDEVICE GROUPING \t\t\t\t\t\t<\/a>\n\t\t\t\t\t<\/h3>\n\t\t\t\t\n\t\t\t\t\n\t\t\t<\/div>\n\t\t\t\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"<p>DEVICE CLASSIFICATION AND DEVICE GROUPING In Costa Rica, the Ministry of Health (MoH) is the entity in charge of developing the laws and regulations for medical devices or EMB (Equipment and Biomedical Material) \u2013both terms are considered synonymous in this document and used interchangeably. The classification of such devices or EMBs is designated based on [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":1287,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"elementor_canvas","meta":{"footnotes":""},"class_list":["post-1422","page","type-page","status-publish","hentry"],"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>Classification and Grouping of Medical Devices in Costa Rica<\/title>\n<meta name=\"description\" content=\"Expert guidance on classification and grouping according to the Ministry of Health regulations. 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