{"id":3280,"date":"2025-09-18T19:45:08","date_gmt":"2025-09-18T19:45:08","guid":{"rendered":"https:\/\/veraqueconsulting.com\/co\/?p=3280"},"modified":"2025-09-18T19:45:08","modified_gmt":"2025-09-18T19:45:08","slug":"breathing-systems-classification-and-grouping-in-colombia","status":"publish","type":"post","link":"https:\/\/veraqueconsulting.com\/co\/breathing-systems-classification-and-grouping-in-colombia\/","title":{"rendered":"Breathing Systems: Classification and Grouping in Colombia"},"content":{"rendered":"<p><span data-contrast=\"auto\">This article continues our series on classification o<\/span><span data-contrast=\"auto\">f medical devices related to respiratory therapy in Colombia, where we have covered topics like <\/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\"> and <\/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\">. In this edition, we turn our attention to the regulatory framework for registering breathing systems with INVIMA,<\/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<h3><b><span data-contrast=\"auto\">What is a Breathing System?<\/span><\/b><span data-ccp-props=\"{&quot;335551550&quot;:6,&quot;335551620&quot;:6}\">\u00a0<\/span><\/h3>\n<p>&nbsp;<\/p>\n<p><span data-contrast=\"auto\">Breathing systems are specialized medical apparatuses designed to deliver oxygen and\/or air to patients requiring respiratory support. They operate in conjunction with a range of airway management devices, 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\"> nasal cannulas, and face<\/span><span data-contrast=\"auto\"> masks. <\/span><\/p>\n<p>&nbsp;<\/p>\n<p><span data-contrast=\"auto\">These systems are essential in diverse clinical settings, including operating rooms, emergency rooms, intensive care units (ICUs), and home healthcare environments. Beyond maintaining a steady flow of respiratory gases, they also support critical physiological functions like the removal of carbon dioxide and the control of air humidity and temperature.<\/span><span data-ccp-props=\"{&quot;335551550&quot;:6,&quot;335551620&quot;:6,&quot;469777462&quot;:[720],&quot;469777927&quot;:[0],&quot;469777928&quot;:[8]}\">\u00a0<\/span><\/p>\n<p><span data-ccp-props=\"{&quot;335551550&quot;:6,&quot;335551620&quot;:6,&quot;469777462&quot;:[720],&quot;469777927&quot;:[0],&quot;469777928&quot;:[8]}\">\u00a0<\/span><\/p>\n<h3><b><span data-contrast=\"auto\">What are the components of a breathing system?<\/span><\/b><span data-ccp-props=\"{&quot;335551550&quot;:6,&quot;335551620&quot;:6}\">\u00a0<\/span><\/h3>\n<p><span data-ccp-props=\"{&quot;335551550&quot;:6,&quot;335551620&quot;:6}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">Breathing systems are intricate assemblies of various components working in harmony to ensure their intended use. Key components 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=\"3\" 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\">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=\"{&quot;335551550&quot;:6,&quot;335551620&quot;:6}\">\u00a0<\/span><\/li>\n<\/ul>\n<ul>\n<li data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"3\" 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\">Reservoir bag<\/span><\/b><span data-contrast=\"auto\">: A flexible bag that acts as a temporary gas reservoir and aids in monitoring breathing patterns.<\/span><span data-ccp-props=\"{&quot;335551550&quot;:6,&quot;335551620&quot;:6}\">\u00a0<\/span><\/li>\n<\/ul>\n<ul>\n<li data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"3\" 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\">Connectors and adapters<\/span><\/b><span data-contrast=\"auto\">: Various fittings that ensure proper connections between different parts of the system.<\/span><span data-ccp-props=\"{&quot;335551550&quot;:6,&quot;335551620&quot;:6}\">\u00a0<\/span><\/li>\n<\/ul>\n<ul>\n<li data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"3\" 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\">Valves<\/span><\/b><span data-contrast=\"auto\">: One-way valves that control gas flow and prevent the rebreathing of exhaled carbon dioxide.<\/span><span data-ccp-props=\"{&quot;335551550&quot;:6,&quot;335551620&quot;:6}\">\u00a0<\/span><\/li>\n<\/ul>\n<ul>\n<li data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"3\" 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\">Filters<\/span><\/b><span data-contrast=\"auto\">: Bacterial and viral filters that minimize the risk of infection and cross-contamination.<\/span><span data-ccp-props=\"{&quot;335551550&quot;:6,&quot;335551620&quot;:6}\">\u00a0<\/span><\/li>\n<\/ul>\n<ul>\n<li data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"3\" 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\">CO2 absorber<\/span><\/b><span data-contrast=\"auto\">: (In closed and semi-closed systems) A canister containing chemicals that absorb carbon dioxide from exhaled breath.<\/span><span data-ccp-props=\"{&quot;335551550&quot;:6,&quot;335551620&quot;:6}\">\u00a0<\/span><\/li>\n<\/ul>\n<ul>\n<li data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"3\" 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\">Heat and moisture exchangers (HMEs)<\/span><\/b><span data-contrast=\"auto\">: Devices that conserve the patient&#8217;s exhaled heat and moisture, reducing the need for additional humidification.<\/span><span data-ccp-props=\"{&quot;335551550&quot;:6,&quot;335551620&quot;:6}\">\u00a0<\/span><\/li>\n<\/ul>\n<ul>\n<li data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"3\" 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=\"8\" data-aria-level=\"1\"><b><span data-contrast=\"auto\">Flowmeters<\/span><\/b><span data-contrast=\"auto\">: Devices that precisely control the flow of gases into the circuit.<\/span><span data-ccp-props=\"{&quot;335551550&quot;:6,&quot;335551620&quot;:6}\">\u00a0<\/span><\/li>\n<\/ul>\n<p><span data-ccp-props=\"{&quot;335551550&quot;:6,&quot;335551620&quot;:6}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">It&#8217;s important to note that while breathing systems are often used with ventilators, humidifiers, and monitors, these are considered separate medical devices with their own classifications and registration requirements.<\/span><span data-ccp-props=\"{&quot;335551550&quot;:6,&quot;335551620&quot;:6}\">\u00a0<\/span><\/p>\n<h3><span data-ccp-props=\"{&quot;335551550&quot;:6,&quot;335551620&quot;:6}\">\u00a0<\/span><\/h3>\n<h3><b><span data-contrast=\"auto\">What are the types of breathing systems?<\/span><\/b><span data-ccp-props=\"{&quot;335551550&quot;:6,&quot;335551620&quot;:6}\">\u00a0<\/span><\/h3>\n<p><span data-ccp-props=\"{&quot;335551550&quot;:6,&quot;335551620&quot;:6}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">Breathing systems are mostly classified based on how they manage gas flow and rebreathing:<\/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<ol>\n<li data-leveltext=\"%1.\" data-font=\"\" data-listid=\"4\" data-list-defn-props=\"{&quot;335552541&quot;:0,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769242&quot;:[65533,0],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;%1.&quot;,&quot;469777815&quot;:&quot;multilevel&quot;}\" data-aria-posinset=\"1\" data-aria-level=\"1\"><b><span data-contrast=\"auto\">Open Breathing Systems<\/span><\/b><span data-contrast=\"auto\">: Fresh gas flows continuously from the source to the patient, and exhaled gas is released into the atmosphere. These are rarely used in modern healthcare due to inefficiency and infection control concerns.<\/span><span data-ccp-props=\"{&quot;335551550&quot;:6,&quot;335551620&quot;:6}\">\u00a0<\/span><\/li>\n<li><b><span data-contrast=\"auto\">Semi-Closed Breathing Systems<\/span><\/b><span data-contrast=\"auto\">: These systems allow for partial rebreathing of exhaled gas after it passes through a CO2 absorber. Fresh gas is added to maintain adequate oxygen levels. This type is commonly used in anesthesia and short-term ventilation.<\/span><span data-ccp-props=\"{&quot;335551550&quot;:6,&quot;335551620&quot;:6}\">\u00a0<\/span><\/li>\n<li data-leveltext=\"%1.\" data-font=\"\" data-listid=\"4\" data-list-defn-props=\"{&quot;335552541&quot;:0,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769242&quot;:[65533,0],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;%1.&quot;,&quot;469777815&quot;:&quot;multilevel&quot;}\" data-aria-posinset=\"3\" data-aria-level=\"1\"><b><span data-contrast=\"auto\">Closed Breathing Systems<\/span><\/b><span data-contrast=\"auto\">: These systems re-breathe all exhaled gas after CO2 absorption, minimizing the need for fresh gas flow. They are often preferred for long-term ventilation in critical care settings.<\/span><span data-ccp-props=\"{&quot;335551550&quot;:6,&quot;335551620&quot;:6}\">\u00a0<\/span><\/li>\n<\/ol>\n<p><span data-ccp-props=\"{&quot;335551550&quot;:6,&quot;335551620&quot;:6,&quot;335559685&quot;:720}\">\u00a0<\/span><\/p>\n<h3><b><span data-contrast=\"auto\">Specialized Breathing Systems:<\/span><\/b><span data-ccp-props=\"{&quot;335551550&quot;:6,&quot;335551620&quot;:6}\">\u00a0<\/span><\/h3>\n<p><span data-ccp-props=\"{&quot;335551550&quot;:6,&quot;335551620&quot;:6}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">In addition to the main types, there are specialized breathing systems designed for specific applications:<\/span><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=\"5\" 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\">Pediatric circuits<\/span><\/b><span data-contrast=\"auto\">: Adapted for infants and children with smaller lung volumes and specific needs.<\/span><span data-ccp-props=\"{&quot;335551550&quot;:6,&quot;335551620&quot;:6}\">\u00a0<\/span><\/li>\n<\/ul>\n<ul>\n<li data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"5\" 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\">Coaxial circuits<\/span><\/b><span data-contrast=\"auto\">: Employ a &#8220;tube within a tube&#8221; design for efficient gas flow and heat conservation.<\/span><span data-ccp-props=\"{&quot;335551550&quot;:6,&quot;335551620&quot;:6}\">\u00a0<\/span><\/li>\n<\/ul>\n<ul>\n<li data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"5\" 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\">Continuous positive airway pressure (CPAP) circuits<\/span><\/b><span data-contrast=\"auto\">: Used to deliver continuous positive pressure to the airways, often for sleep apnea or respiratory distress.<\/span><span data-ccp-props=\"{&quot;335551550&quot;:6,&quot;335551620&quot;:6}\">\u00a0<\/span><\/li>\n<\/ul>\n<ul>\n<li data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"5\" 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\">Heated wire breathing systems (HWBS)<\/span><\/b><span data-contrast=\"auto\">: Incorporate heated wires within the circuit to maintain optimal humidity and temperature, reducing condensation and complications.<\/span><span data-ccp-props=\"{&quot;335551550&quot;:6,&quot;335551620&quot;:6}\">\u00a0<\/span><\/li>\n<\/ul>\n<h3><span data-ccp-props=\"{&quot;335551550&quot;:6,&quot;335551620&quot;:6,&quot;335559685&quot;:720}\">\u00a0<\/span><\/h3>\n<h3><b><span data-contrast=\"auto\">How are the Breathing Systems <\/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=\"{&quot;335551550&quot;:6,&quot;335551620&quot;:6}\">\u00a0<\/span><\/h3>\n<p><span data-contrast=\"auto\">Breathing systems fall under <\/span><b><span data-contrast=\"auto\">Class IIa <\/span><\/b><span data-contrast=\"auto\">medical devices. This classification reflects their non-invasive nature and their function in conducting gases to a patient connected to a <\/span><b><span data-contrast=\"auto\">Class IIa<\/span><\/b><span data-contrast=\"auto\"> active device (e.g., a ventilator).<\/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<h3><b><span data-contrast=\"auto\">Grouping Strategy for <\/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=\"{&quot;335551550&quot;:6,&quot;335551620&quot;:6}\">\u00a0<\/span><\/h3>\n<p><span data-ccp-props=\"{&quot;335551550&quot;:6,&quot;335551620&quot;:6}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">Due to the wide variety of breathing systems available, grouping them for registration with INVIMA requires a strategic approach. Here are some important considerations:<\/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=\"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\">Similarities<\/span><\/b><span data-contrast=\"auto\">: Breathing systems with the same intended use and materials can be grouped under a single registration, even if they have variations in size (adult, pediatric, neonatal), tubing length, or the number and type of connectors and accessories.<\/span><span data-ccp-props=\"{&quot;335551550&quot;:6,&quot;335551620&quot;:6}\">\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=\"2\" data-aria-level=\"1\"><b><span data-contrast=\"auto\">Types<\/span><\/b><span data-contrast=\"auto\">: Different types of breathing systems (e.g., CPAP, HWBS) can be grouped if they share similar materials and construction, even with specific components for each model.<\/span><span data-ccp-props=\"{&quot;335551550&quot;:6,&quot;335551620&quot;:6}\">\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=\"3\" data-aria-level=\"1\"><b><span data-contrast=\"auto\">Sterility<\/span><\/b><span data-contrast=\"auto\">: While most breathing systems are provided non-sterile, sterility and re-sterilization information must be clearly defined for each grouped device.<\/span><span data-ccp-props=\"{&quot;335551550&quot;:6,&quot;335551620&quot;:6}\">\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=\"4\" data-aria-level=\"1\"><b><span data-contrast=\"auto\">Technical documentation<\/span><\/b><span data-contrast=\"auto\">: Comprehensive technical information for all components, including those of the most complex system within the group, must be included in the registration dossier.<\/span><span data-ccp-props=\"{&quot;335551550&quot;:6,&quot;335551620&quot;:6}\">\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=\"5\" data-aria-level=\"1\"><b><span data-contrast=\"auto\">Performance testing<\/span><\/b><span data-contrast=\"auto\">: Performance testing data must cover all models within the group for each component and accessory.<\/span><span data-ccp-props=\"{&quot;335551550&quot;:6,&quot;335551620&quot;:6}\">\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=\"6\" data-aria-level=\"1\"><b><span data-contrast=\"auto\">Components and accessories<\/span><\/b><span data-contrast=\"auto\">: Filters, HMEs, CO2 absorbers, and other components may be considered medical devices themselves. Justification for their inclusion in the system is necessary when they are not packaged together or are not for exclusive use with the circuits.<\/span><span data-ccp-props=\"{&quot;335551550&quot;:6,&quot;335551620&quot;:6}\">\u00a0<\/span><\/li>\n<\/ul>\n<p><span data-ccp-props=\"{&quot;335551550&quot;:6,&quot;335551620&quot;:6,&quot;335559685&quot;:720}\">\u00a0<\/span><\/p>\n<p><i><span data-contrast=\"auto\">Remember that ventilators, humidifiers, and monitors require separate registrations as they are independent medical devices, potentially falling under different classifications.<\/span><\/i><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<h3><b><span data-contrast=\"auto\">Conclusion<\/span><\/b><span data-ccp-props=\"{&quot;335551550&quot;:6,&quot;335551620&quot;:6}\">\u00a0<\/span><\/h3>\n<p>&nbsp;<\/p>\n<p><span data-contrast=\"auto\">Breathing systems serve a crucial function in respiratory care across a wide range of clinical environments. In Colombia, a clear understanding of their classification, components, and grouping criteria is fundamental for navigating the registration process. By adhering to INVIMA\u2019s regulatory requirements and submitting thorough technical documentation, manufacturers can achieve compliance and successfully access the Colombian healthcare market.<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;201341983&quot;:0,&quot;335551550&quot;:6,&quot;335551620&quot;:6,&quot;335559685&quot;:0,&quot;335559737&quot;:0,&quot;335559738&quot;:0,&quot;335559739&quot;:160,&quot;335559740&quot;:259}\">\u00a0<\/span><\/p>\n<p><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;201341983&quot;:0,&quot;335551550&quot;:6,&quot;335551620&quot;:6,&quot;335559685&quot;:0,&quot;335559737&quot;:0,&quot;335559738&quot;:0,&quot;335559739&quot;:160,&quot;335559740&quot;:259}\">\u00a0<\/span><\/p>\n<p><b><span data-contrast=\"auto\">Do you have questions about registering breathing systems or other medical devices in Colombia?\u00a0<\/span><\/b><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<p><span data-contrast=\"auto\">Contact us today for expert guidance and support throughout the regulatory process. Our team at <\/span><a href=\"mailto:contact@veraqueconsulting.com?subject=COFEPRIS%20FEES\"><span data-contrast=\"none\">Veraque<\/span><\/a><span data-contrast=\"auto\"> is dedicated to helping you travel through the complex Colombia&#8217;s regulations.<\/span><span data-ccp-props=\"{&quot;335551550&quot;:6,&quot;335551620&quot;:6}\">\u00a0<\/span><\/p>\n","protected":false},"excerpt":{"rendered":"<p>This article continues our series on classification of medical devices related to respiratory therapy in Colombia, where we have covered topics like anesthesia circuits and oxygen masks. In this edition, we turn our attention to the regulatory framework for registering breathing systems with INVIMA,\u00a0 \u00a0 What is a Breathing System?\u00a0 &nbsp; Breathing systems are specialized [&hellip;]<\/p>\n","protected":false},"author":6,"featured_media":3281,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[367,396],"tags":[],"class_list":["post-3280","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>Breathing Systems: Classification and Grouping in Colombia - Veraque Colombia<\/title>\n<meta name=\"description\" content=\"A review of breathing systems configurations, classification and grouping principles in Colombia\u2019s healthcare environment.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/veraqueconsulting.com\/co\/breathing-systems-classification-and-grouping-in-colombia\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Breathing Systems: Classification and Grouping in Colombia\" \/>\n<meta property=\"og:description\" content=\"A review of breathing systems configurations, classification and grouping principles in Colombia\u2019s healthcare environment.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/veraqueconsulting.com\/co\/breathing-systems-classification-and-grouping-in-colombia\/\" \/>\n<meta property=\"og:site_name\" content=\"Veraque Colombia\" \/>\n<meta property=\"article:published_time\" content=\"2025-09-18T19:45:08+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/veraqueconsulting.com\/co\/wp-content\/uploads\/sites\/4\/2025\/09\/classification_breathing_systems_colombia.png\" \/>\n\t<meta property=\"og:image:width\" content=\"940\" \/>\n\t<meta property=\"og:image:height\" content=\"788\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/png\" \/>\n<meta name=\"author\" content=\"mkt1\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"mkt1\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"5 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\\\/\\\/veraqueconsulting.com\\\/co\\\/breathing-systems-classification-and-grouping-in-colombia\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/veraqueconsulting.com\\\/co\\\/breathing-systems-classification-and-grouping-in-colombia\\\/\"},\"author\":{\"name\":\"mkt1\",\"@id\":\"https:\\\/\\\/veraqueconsulting.com\\\/co\\\/#\\\/schema\\\/person\\\/3f760cd8f7128ca81c70930dcfcc1e44\"},\"headline\":\"Breathing Systems: Classification and Grouping in Colombia\",\"datePublished\":\"2025-09-18T19:45:08+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/veraqueconsulting.com\\\/co\\\/breathing-systems-classification-and-grouping-in-colombia\\\/\"},\"wordCount\":908,\"publisher\":{\"@id\":\"https:\\\/\\\/veraqueconsulting.com\\\/co\\\/#organization\"},\"image\":{\"@id\":\"https:\\\/\\\/veraqueconsulting.com\\\/co\\\/breathing-systems-classification-and-grouping-in-colombia\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/veraqueconsulting.com\\\/co\\\/wp-content\\\/uploads\\\/sites\\\/4\\\/2025\\\/09\\\/classification_breathing_systems_colombia.png\",\"articleSection\":[\"classification\",\"Colombia\"],\"inLanguage\":\"en-US\"},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/veraqueconsulting.com\\\/co\\\/breathing-systems-classification-and-grouping-in-colombia\\\/\",\"url\":\"https:\\\/\\\/veraqueconsulting.com\\\/co\\\/breathing-systems-classification-and-grouping-in-colombia\\\/\",\"name\":\"Breathing Systems: Classification and Grouping in Colombia - 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