{"id":3301,"date":"2025-09-22T19:13:47","date_gmt":"2025-09-22T19:13:47","guid":{"rendered":"https:\/\/veraqueconsulting.com\/co\/?p=3301"},"modified":"2026-02-27T16:18:35","modified_gmt":"2026-02-27T16:18:35","slug":"humidifiers-and-heated-wire-breathing-systems-classification-and-grouping-in-colombia","status":"publish","type":"post","link":"https:\/\/veraqueconsulting.com\/co\/humidifiers-and-heated-wire-breathing-systems-classification-and-grouping-in-colombia\/","title":{"rendered":"Humidifiers and Heated Wire Breathing Systems: Classification and Grouping in Colombia"},"content":{"rendered":"<p><span data-contrast=\"auto\">This article concludes our series on respiratory therapy-related medical devices, which has examined components such as <\/span><a href=\"https:\/\/veraqueconsulting.com\/co\/anesthesia-circuits-classification-and-grouping-in-colombia\/\" target=\"_blank\" rel=\"noopener\"><span data-contrast=\"none\">anesthesia circuits<\/span><\/a><span data-contrast=\"auto\">, <\/span><a href=\"https:\/\/veraqueconsulting.com\/co\/anesthesia-and-oxygen-delivery-masks-classification-and-grouping-in-colombia\/\" target=\"_blank\" rel=\"noopener\"><span data-contrast=\"none\">oxygen masks<\/span><\/a><span data-contrast=\"auto\">, and <\/span><a href=\"https:\/\/veraqueconsulting.com\/co\/breathing-systems-classification-and-grouping-in-colombia\/\" target=\"_blank\" rel=\"noopener\"><span data-contrast=\"none\">breathing systems<\/span><\/a><span data-contrast=\"auto\">. In this final segment, we focus on the regulatory pathway for <\/span><a href=\"https:\/\/veraqueconsulting.com\/co\/guides\/ultimate-guide-for-regulatory-affairs-in-colombia\/#register\" target=\"_blank\" rel=\"noopener\"><span data-contrast=\"none\">registering<\/span><\/a><span data-contrast=\"auto\"> humidifiers and heated wire breathing systems (HWBS) in Colombia, a growing market of interest for global medical device manufacturers.<\/span><span data-ccp-props=\"{}\">\u00a0<\/span><\/p>\n<p><span data-ccp-props=\"{}\">\u00a0<\/span><\/p>\n<h3><\/h3>\n<h3><b><span data-contrast=\"auto\">What are Humidifiers and Heated Wire Breathing Systems?<\/span><\/b><span data-ccp-props=\"{}\">\u00a0<\/span><\/h3>\n<p>&nbsp;<\/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;multilevel&quot;}\" data-aria-posinset=\"1\" data-aria-level=\"1\"><b><span data-contrast=\"auto\">Humidifiers <\/span><\/b><span data-contrast=\"auto\">are respiratory support devices engineered to introduce moisture, and in many cases, heat, into the gases delivered to patients. Their use helps reduce complications associated with dry gas inhalation, particularly in cases involving extended mechanical ventilation.<\/span><span data-ccp-props=\"{}\">\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;multilevel&quot;}\" data-aria-posinset=\"2\" data-aria-level=\"1\"><b><span data-contrast=\"auto\">Heated Wire Breathing Systems (HWBS)<\/span><\/b><span data-contrast=\"auto\"> are advanced breathing circuits that feature heated wires embedded within the tubing. This configuration maintains consistent gas temperature and minimizes condensation, which can interfere with ventilation performance and increase the risk of microbial growth.<\/span><span data-ccp-props=\"{}\">\u00a0<\/span><\/li>\n<\/ul>\n<p><span data-ccp-props=\"{}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">These devices are commonly deployed alongside<\/span> <a href=\"https:\/\/veraqueconsulting.com\/co\/mechanical-ventilators-classification-and-grouping-in-colombia\/\" target=\"_blank\" rel=\"noopener\"><span data-contrast=\"none\">mechanical ventilators<\/span><\/a> <span data-contrast=\"auto\">and airway management tools such as <\/span><a href=\"https:\/\/veraqueconsulting.com\/co\/endotracheal-tubes-classification-and-grouping-in-colombia\/\" target=\"_blank\" rel=\"noopener\"><span data-contrast=\"none\">endotracheal tubes, laryngeal masks<\/span><\/a><span data-contrast=\"auto\">, and face <\/span><a href=\"https:\/\/veraqueconsulting.com\/co\/anesthesia-and-oxygen-delivery-masks-classification-and-grouping-in-colombia\/\" target=\"_blank\" rel=\"noopener\"><span data-contrast=\"none\">masks<\/span><\/a><span data-contrast=\"auto\">. Their application spans multiple care environments: surgical suites, emergency departments, intensive care units (ICUs) and home-based respiratory care.<\/span><span data-ccp-props=\"{}\">\u00a0<\/span><\/p>\n<p><span data-ccp-props=\"{}\">\u00a0<\/span><\/p>\n<h3><\/h3>\n<h3><span data-ccp-props=\"{}\"><strong>Component Breakdown and Functional Integration of Humidifiers and HWBS<\/strong><br \/>\n<\/span><\/h3>\n<p>&nbsp;<\/p>\n<p><span data-contrast=\"auto\">Humidifiers and HWBS, while separate devices, work synergistically:<\/span><span data-ccp-props=\"{}\">\u00a0<\/span><\/p>\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\">\n<h5><b><span data-contrast=\"auto\">Humidifier Components:<\/span><\/b><span data-ccp-props=\"{}\">\u00a0<\/span><\/h5>\n<\/li>\n<\/ul>\n<ul>\n<li style=\"list-style-type: none\">\n<ul>\n<li data-leveltext=\"o\" data-font=\"Courier New\" data-listid=\"2\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559685&quot;:1440,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Courier New&quot;,&quot;469769242&quot;:[9675],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;o&quot;,&quot;469777815&quot;:&quot;multilevel&quot;}\" data-aria-posinset=\"1\" data-aria-level=\"2\"><b><span data-contrast=\"auto\">Heating Element:<\/span><\/b><span data-contrast=\"auto\"> Warms the water to create water vapor.<\/span><span data-ccp-props=\"{}\">\u00a0<\/span><\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<ul>\n<li style=\"list-style-type: none\">\n<ul>\n<li data-leveltext=\"o\" data-font=\"Courier New\" data-listid=\"2\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559685&quot;:1440,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Courier New&quot;,&quot;469769242&quot;:[9675],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;o&quot;,&quot;469777815&quot;:&quot;multilevel&quot;}\" data-aria-posinset=\"2\" data-aria-level=\"2\"><b><span data-contrast=\"auto\">Water Chamber:<\/span><\/b><span data-contrast=\"auto\"> A reservoir holding sterile water. This can be a pre-filled, disposable chamber or a refillable chamber.<\/span><span data-ccp-props=\"{}\">\u00a0<\/span><\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<ul>\n<li style=\"list-style-type: none\">\n<ul>\n<li data-leveltext=\"o\" data-font=\"Courier New\" data-listid=\"2\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559685&quot;:1440,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Courier New&quot;,&quot;469769242&quot;:[9675],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;o&quot;,&quot;469777815&quot;:&quot;multilevel&quot;}\" data-aria-posinset=\"3\" data-aria-level=\"2\"><b><span data-contrast=\"auto\">Temperature Control System:<\/span><\/b><span data-contrast=\"auto\"> Allows clinicians to adjust the temperature and, indirectly, the humidity level.<\/span><span data-ccp-props=\"{}\">\u00a0<\/span><\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<ul>\n<li style=\"list-style-type: none\">\n<ul>\n<li data-leveltext=\"o\" data-font=\"Courier New\" data-listid=\"2\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559685&quot;:1440,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Courier New&quot;,&quot;469769242&quot;:[9675],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;o&quot;,&quot;469777815&quot;:&quot;multilevel&quot;}\" data-aria-posinset=\"4\" data-aria-level=\"2\"><b><span data-contrast=\"auto\">Connection Ports:<\/span><\/b><span data-contrast=\"auto\"> To connect to the breathing circuit (often the inspiratory limb).<\/span><span data-ccp-props=\"{}\">\u00a0<\/span><\/li>\n<\/ul>\n<\/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\">\n<h5><b><span data-contrast=\"auto\">HWBS Components:<\/span><\/b><span data-ccp-props=\"{}\">\u00a0<\/span><\/h5>\n<\/li>\n<\/ul>\n<ul>\n<li style=\"list-style-type: none\">\n<ul>\n<li data-leveltext=\"o\" data-font=\"Courier New\" data-listid=\"2\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559685&quot;:1440,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Courier New&quot;,&quot;469769242&quot;:[9675],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;o&quot;,&quot;469777815&quot;:&quot;multilevel&quot;}\" data-aria-posinset=\"1\" data-aria-level=\"2\"><b><span data-contrast=\"auto\">Breathing Tubes:<\/span><\/b><span data-contrast=\"auto\"> Flexible tubes connecting the patient&#8217;s airway to the oxygen source or ventilator.<\/span><span data-ccp-props=\"{}\">\u00a0<\/span><\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<ul>\n<li style=\"list-style-type: none\">\n<ul>\n<li data-leveltext=\"o\" data-font=\"Courier New\" data-listid=\"2\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559685&quot;:1440,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Courier New&quot;,&quot;469769242&quot;:[9675],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;o&quot;,&quot;469777815&quot;:&quot;multilevel&quot;}\" data-aria-posinset=\"2\" data-aria-level=\"2\"><b><span data-contrast=\"auto\">Heated Wires:<\/span><\/b><span data-contrast=\"auto\"> Run along the inspiratory limb (and often the expiratory limb) of the breathing circuit.<\/span><span data-ccp-props=\"{}\">\u00a0<\/span><\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<ul>\n<li style=\"list-style-type: none\">\n<ul>\n<li data-leveltext=\"o\" data-font=\"Courier New\" data-listid=\"2\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559685&quot;:1440,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Courier New&quot;,&quot;469769242&quot;:[9675],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;o&quot;,&quot;469777815&quot;:&quot;multilevel&quot;}\" data-aria-posinset=\"3\" data-aria-level=\"2\"><b><span data-contrast=\"auto\">Temperature Sensors:<\/span><\/b><span data-contrast=\"auto\"> Located within the circuit (often near the patient connection) to monitor gas temperature.<\/span><span data-ccp-props=\"{}\">\u00a0<\/span><\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<ul>\n<li style=\"list-style-type: none\">\n<ul>\n<li data-leveltext=\"o\" data-font=\"Courier New\" data-listid=\"2\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559685&quot;:1440,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Courier New&quot;,&quot;469769242&quot;:[9675],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;o&quot;,&quot;469777815&quot;:&quot;multilevel&quot;}\" data-aria-posinset=\"4\" data-aria-level=\"2\"><b><span data-contrast=\"auto\">Controller\/Adapter:<\/span><\/b><span data-contrast=\"auto\"> connects the heated wires to a power source from the ventilator and transmits sensor data.<\/span><span data-ccp-props=\"{}\">\u00a0<\/span><\/li>\n<\/ul>\n<\/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\">What types of Humidifiers are used with HWBS?<\/span><\/b><span data-ccp-props=\"{}\">\u00a0<\/span><\/h3>\n<p><span data-ccp-props=\"{}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">Humidifiers used with HWBS are primarily classified based on their heating method and water chamber type:<\/span><span data-ccp-props=\"{}\">\u00a0<\/span><\/p>\n<ul>\n<li data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"4\" 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\">Heated Humidifiers:<\/span><\/b><span data-contrast=\"auto\"> These are the most common type, using a heating element to warm the water. They offer precise control over temperature and humidity.<\/span><span data-ccp-props=\"{}\">\u00a0<\/span><\/li>\n<\/ul>\n<ul>\n<li style=\"list-style-type: none\">\n<ul>\n<li data-leveltext=\"o\" data-font=\"Courier New\" data-listid=\"4\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559685&quot;:1440,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Courier New&quot;,&quot;469769242&quot;:[9675],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;o&quot;,&quot;469777815&quot;:&quot;multilevel&quot;}\" data-aria-posinset=\"1\" data-aria-level=\"2\"><b><span data-contrast=\"auto\">Pass-over Humidifiers:<\/span><\/b><span data-contrast=\"auto\"> Gas flows over the surface of the heated water.<\/span><span data-ccp-props=\"{}\">\u00a0<\/span><\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<ul>\n<li style=\"list-style-type: none\">\n<ul>\n<li data-leveltext=\"o\" data-font=\"Courier New\" data-listid=\"4\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559685&quot;:1440,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Courier New&quot;,&quot;469769242&quot;:[9675],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;o&quot;,&quot;469777815&quot;:&quot;multilevel&quot;}\" data-aria-posinset=\"2\" data-aria-level=\"2\"><b><span data-contrast=\"auto\">Bubble Humidifiers:<\/span><\/b><span data-contrast=\"auto\"> Gas is bubbled through the heated water (less common with ventilators, more common with lower-flow oxygen therapy).<\/span><span data-ccp-props=\"{}\">\u00a0<\/span><\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<ul>\n<li data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"4\" 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\">Water Chamber Types:<\/span><\/b><span data-ccp-props=\"{}\">\u00a0<\/span><\/li>\n<\/ul>\n<ul>\n<li style=\"list-style-type: none\">\n<ul>\n<li data-leveltext=\"o\" data-font=\"Courier New\" data-listid=\"4\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559685&quot;:1440,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Courier New&quot;,&quot;469769242&quot;:[9675],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;o&quot;,&quot;469777815&quot;:&quot;multilevel&quot;}\" data-aria-posinset=\"1\" data-aria-level=\"2\"><b><span data-contrast=\"auto\">Refillable Chambers:<\/span><\/b><span data-contrast=\"auto\"> Require manual refilling with sterile water.<\/span><span data-ccp-props=\"{}\">\u00a0<\/span><\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<ul>\n<li style=\"list-style-type: none\">\n<ul>\n<li data-leveltext=\"o\" data-font=\"Courier New\" data-listid=\"4\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559685&quot;:1440,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Courier New&quot;,&quot;469769242&quot;:[9675],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;o&quot;,&quot;469777815&quot;:&quot;multilevel&quot;}\" data-aria-posinset=\"2\" data-aria-level=\"2\"><b><span data-contrast=\"auto\">Pre-filled, Disposable Chambers:<\/span><\/b><span data-contrast=\"auto\"> Single-use chambers pre-filled with sterile water, reducing the risk of contamination.<\/span><span data-ccp-props=\"{}\">\u00a0<\/span><\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<ul>\n<li style=\"list-style-type: none\">\n<ul>\n<li data-leveltext=\"o\" data-font=\"Courier New\" data-listid=\"4\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559685&quot;:1440,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Courier New&quot;,&quot;469769242&quot;:[9675],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;o&quot;,&quot;469777815&quot;:&quot;multilevel&quot;}\" data-aria-posinset=\"3\" data-aria-level=\"2\"><b><span data-contrast=\"auto\">Auto-feed systems:<\/span><\/b><span data-contrast=\"auto\"> The humidifier automatically refills from a larger sterile water source.<\/span><span data-ccp-props=\"{}\">\u00a0<\/span><\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<p><span data-ccp-props=\"{}\">\u00a0<\/span><\/p>\n<h3><span data-ccp-props=\"{}\">\u00a0<\/span><\/h3>\n<h3><b><span data-contrast=\"auto\">How are Humidifiers and HWBS <\/span><\/b><a href=\"https:\/\/veraqueconsulting.com\/co\/guides\/device-classification-and-device-grouping-colombia\/\" target=\"_blank\" rel=\"noopener\"><b><span data-contrast=\"none\">Classified and Grouped in Colombia<\/span><\/b><\/a><b><span data-contrast=\"auto\">?<\/span><\/b><span data-ccp-props=\"{}\">\u00a0<\/span><\/h3>\n<p><span data-ccp-props=\"{}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">Both humidifiers and HWBS are classified as <\/span><b><span data-contrast=\"auto\">Class IIa <\/span><\/b><span data-contrast=\"auto\">medical devices under Decree 4725 of 2005, based on their non-invasive function of conducting gases intended for administration to the body and their connection to active devices such as mechanical ventilators.<\/span><span data-ccp-props=\"{}\">\u00a0<\/span><\/p>\n<p><span data-ccp-props=\"{&quot;335559685&quot;:720}\">\u00a0<\/span><\/p>\n<h3><b><span data-contrast=\"auto\">Grouping Strategy for Humidifier <\/span><\/b><a href=\"https:\/\/veraqueconsulting.com\/co\/guides\/ultimate-guide-for-regulatory-affairs-in-colombia\/#register\" target=\"_blank\" rel=\"noopener\"><b><span data-contrast=\"none\">Registration<\/span><\/b><\/a><b><span data-contrast=\"auto\">:<\/span><\/b><span data-ccp-props=\"{}\">\u00a0<\/span><\/h3>\n<p><span data-ccp-props=\"{}\">\u00a0<\/span><\/p>\n<ul>\n<li data-leveltext=\"o\" data-font=\"Courier New\" data-listid=\"5\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559685&quot;:1440,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Courier New&quot;,&quot;469769242&quot;:[9675],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;o&quot;,&quot;469777815&quot;:&quot;multilevel&quot;}\" data-aria-posinset=\"1\" data-aria-level=\"2\"><b><span data-contrast=\"auto\">Separate Registrations:<\/span><\/b><span data-contrast=\"auto\"> Humidifiers and HWBS require separate registrations with INVIMA, even though they are often used together; they are distinct devices with different indications of use and classifications.<\/span><span data-ccp-props=\"{}\">\u00a0<\/span><\/li>\n<\/ul>\n<ul>\n<li data-leveltext=\"o\" data-font=\"Courier New\" data-listid=\"5\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559685&quot;:1440,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Courier New&quot;,&quot;469769242&quot;:[9675],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;o&quot;,&quot;469777815&quot;:&quot;multilevel&quot;}\" data-aria-posinset=\"2\" data-aria-level=\"2\"><b><span data-contrast=\"auto\">Humidifier Grouping:<\/span><\/b><span data-contrast=\"auto\"> Humidifiers with the same intended use, heating method, and similar materials can be grouped, even with variations in water chamber type (refillable vs. pre-filled), temperature control features.<\/span><span data-ccp-props=\"{}\">\u00a0<\/span><\/li>\n<\/ul>\n<ul>\n<li data-leveltext=\"o\" data-font=\"Courier New\" data-listid=\"5\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559685&quot;:1440,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Courier New&quot;,&quot;469769242&quot;:[9675],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;o&quot;,&quot;469777815&quot;:&quot;multilevel&quot;}\" data-aria-posinset=\"3\" data-aria-level=\"2\"><b><span data-contrast=\"auto\">HWBS Grouping:<\/span><\/b><span data-contrast=\"auto\"> Follows the guidelines outlined for regular Breathing Systems (similar materials, intended use, variations in length\/connectors allowed).<\/span><span data-ccp-props=\"{}\">\u00a0<\/span><\/li>\n<\/ul>\n<p><span data-ccp-props=\"{&quot;335559685&quot;:1440}\">\u00a0<\/span><\/p>\n<h3><b><span data-contrast=\"auto\">Specifications to be considered:<\/span><\/b><span data-ccp-props=\"{}\">\u00a0<\/span><\/h3>\n<p><span data-ccp-props=\"{}\">\u00a0<\/span><\/p>\n<ul>\n<li data-leveltext=\"o\" data-font=\"Courier New\" data-listid=\"5\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559685&quot;:1440,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Courier New&quot;,&quot;469769242&quot;:[9675],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;o&quot;,&quot;469777815&quot;:&quot;multilevel&quot;}\" data-aria-posinset=\"4\" data-aria-level=\"2\"><b><span data-contrast=\"auto\">Performance Testing:<\/span><\/b><span data-contrast=\"auto\"> The humidifier and HWBS should undergo joint testing to confirm that the system consistently achieves the intended temperature and humidity levels without complications.<\/span><span data-ccp-props=\"{}\">\u00a0<\/span><\/li>\n<\/ul>\n<ul>\n<li data-leveltext=\"o\" data-font=\"Courier New\" data-listid=\"5\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559685&quot;:1440,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Courier New&quot;,&quot;469769242&quot;:[9675],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;o&quot;,&quot;469777815&quot;:&quot;multilevel&quot;}\" data-aria-posinset=\"5\" data-aria-level=\"2\"><b><span data-contrast=\"auto\">Instructions for Use:<\/span><\/b><span data-contrast=\"auto\"> Clear guidelines must be provided for both devices, detailing how to safely and effectively connect and operate them together.<\/span><span data-ccp-props=\"{}\">\u00a0<\/span><\/li>\n<\/ul>\n<ul>\n<li data-leveltext=\"o\" data-font=\"Courier New\" data-listid=\"7\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559685&quot;:1428,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Courier New&quot;,&quot;469769242&quot;:[9675],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;o&quot;,&quot;469777815&quot;:&quot;hybridMultilevel&quot;}\" data-aria-posinset=\"1\" data-aria-level=\"1\"><b><span data-contrast=\"auto\">Sterility:<\/span><\/b><span data-contrast=\"auto\"> Explicit definitions of sterility requirements and re-sterilization protocols must be established for each grouped device, including the HWBS kit.<\/span><\/li>\n<\/ul>\n<ul>\n<li data-leveltext=\"o\" data-font=\"Courier New\" data-listid=\"7\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559685&quot;:1428,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Courier New&quot;,&quot;469769242&quot;:[9675],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;o&quot;,&quot;469777815&quot;:&quot;hybridMultilevel&quot;}\" data-aria-posinset=\"2\" data-aria-level=\"1\"><b><span data-contrast=\"auto\">Technical Documentation:<\/span><\/b><span data-contrast=\"auto\"> The registration dossier must contain comprehensive technical specifications for all components of the system.<\/span><\/li>\n<\/ul>\n<ul>\n<li data-leveltext=\"o\" data-font=\"Courier New\" data-listid=\"7\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559685&quot;:1428,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Courier New&quot;,&quot;469769242&quot;:[9675],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;o&quot;,&quot;469777815&quot;:&quot;hybridMultilevel&quot;}\" data-aria-posinset=\"3\" data-aria-level=\"1\"><b><span data-contrast=\"auto\">Components and Accessories:<\/span><\/b><span data-contrast=\"auto\"> A rationale for including specific components and accessories is required, particularly when they are not packaged together or designed exclusively for use with the circuits.<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/li>\n<\/ul>\n<p><span data-ccp-props=\"{&quot;335559685&quot;:1440}\">\u00a0<\/span><\/p>\n<h3><span data-ccp-props=\"{&quot;335559685&quot;:1440}\">\u00a0<\/span><\/h3>\n<h3><b><span data-contrast=\"auto\">Conclusion<\/span><\/b><span data-ccp-props=\"{}\">\u00a0<\/span><\/h3>\n<p>&nbsp;<\/p>\n<p><span data-contrast=\"auto\">Humidifiers and Heated Wire Breathing Systems (HWBS) play a defined role in respiratory therapy and are subject to distinct regulatory classifications. Recognizing the differences between these devices and applying appropriate grouping strategies for registration in Colombia is key for manufacturers aiming to navigate INVIMA\u2019s requirements and achieve market entry.<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335551550&quot;:6,&quot;335551620&quot;:6,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">For guidance on registering humidifiers, HWBS, or other respiratory-related medical devices in Colombia, reach out to our team at <\/span><a href=\"mailto:contact@veraqueconsulting.com\"><b><span data-contrast=\"none\">Veraque<\/span><\/b><\/a><span data-contrast=\"auto\">. We provide regulatory support tailored to the Colombian framework, helping you move efficiently through each step of the approval process.<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335551550&quot;:6,&quot;335551620&quot;:6,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/p>\n","protected":false},"excerpt":{"rendered":"<p>This article concludes our series on respiratory therapy-related medical devices, which has examined components such as anesthesia circuits, oxygen masks, and breathing systems. In this final segment, we focus on the regulatory pathway for registering humidifiers and heated wire breathing systems (HWBS) in Colombia, a growing market of interest for global medical device manufacturers.\u00a0 \u00a0 [&hellip;]<\/p>\n","protected":false},"author":6,"featured_media":3302,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[367,396],"tags":[],"class_list":["post-3301","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-classification","category-colombia"],"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>Humidifiers and HWBS: Classification and Grouping in Colombia - Veraque Colombia<\/title>\n<meta name=\"description\" content=\"Understanding humidifiers &amp; HWBS: learn about their types, components, classification 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