{"id":3376,"date":"2026-04-21T16:56:21","date_gmt":"2026-04-21T16:56:21","guid":{"rendered":"https:\/\/veraqueconsulting.com\/co\/?p=3376"},"modified":"2026-04-21T16:56:21","modified_gmt":"2026-04-21T16:56:21","slug":"intraocular-lenses-iols-classification-and-grouping-in-colombia","status":"publish","type":"post","link":"https:\/\/veraqueconsulting.com\/co\/intraocular-lenses-iols-classification-and-grouping-in-colombia\/","title":{"rendered":"Intraocular Lenses (IOLs): Classification and Grouping in Colombia"},"content":{"rendered":"<p><span data-contrast=\"auto\">Intraocular lenses (IOLs) are\u00a0implantable\u00a0ophthalmic medical devices designed to replace the eye\u2019s natural crystalline lens during cataract extraction or elective refractive procedures. Factors such as optical architecture, biomaterials, and implantation method not only influence clinical performance but also\u00a0determine\u00a0the applicable regulatory pathway in Colombia.<\/span><span data-ccp-props=\"{}\">\u00a0<\/span><\/p>\n<p><span data-ccp-props=\"{}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">This article reviews the principal categories of intraocular lenses, their regulatory classification under Colombian medical device regulations, and the grouping principles applied when\u00a0submitting\u00a0a registration dossier to INVIMA.<\/span><span data-ccp-props=\"{}\">\u00a0<\/span><\/p>\n<p><span data-ccp-props=\"{}\">\u00a0<\/span><\/p>\n<h3><b><span data-contrast=\"auto\">Overview of Intraocular Lens Categories<\/span><\/b><span data-ccp-props=\"{}\">\u00a0<\/span><\/h3>\n<p>&nbsp;<\/p>\n<p><span data-contrast=\"auto\">IOLs are differentiated by optical\u00a0function, construction materials, and delivery systems.\u00a0Each of these attributes has implications for technical documentation and conformity assessment.<\/span><span data-ccp-props=\"{}\">\u00a0<\/span><\/p>\n<ul>\n<li data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"13\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559683&quot;:0,&quot;335559684&quot;:-2,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;\uf0b7&quot;,&quot;469777815&quot;:&quot;hybridMultilevel&quot;}\" data-aria-posinset=\"1\" data-aria-level=\"1\"><strong>Monofocal\u00a0Intraocular Lenses\u00a0<\/strong><\/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=\"13\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559683&quot;:1,&quot;335559684&quot;:-2,&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;hybridMultilevel&quot;}\" data-aria-posinset=\"1\" data-aria-level=\"2\"><span data-contrast=\"auto\">Monofocal\u00a0IOLs are designed to provide vision correction at a single focal distance. Their comparatively simple optical design is typically supported by standardized bench testing, optical characterization, and biocompatibility evaluation.<\/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=\"13\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559683&quot;:0,&quot;335559684&quot;:-2,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;\uf0b7&quot;,&quot;469777815&quot;:&quot;hybridMultilevel&quot;}\" data-aria-posinset=\"2\" data-aria-level=\"1\"><strong>Multifocal and Trifocal Intraocular Lenses\u00a0<\/strong><\/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=\"13\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559683&quot;:1,&quot;335559684&quot;:-2,&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;hybridMultilevel&quot;}\" data-aria-posinset=\"1\" data-aria-level=\"2\"><span data-contrast=\"auto\">These lenses incorporate refractive or diffractive elements to generate multiple focal points. Regulatory submissions\u00a0generally include\u00a0additional\u00a0performance data addressing visual quality parameters such as contrast sensitivity, photic phenomena, and optical design justification.<\/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=\"13\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559683&quot;:0,&quot;335559684&quot;:-2,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;\uf0b7&quot;,&quot;469777815&quot;:&quot;hybridMultilevel&quot;}\" data-aria-posinset=\"3\" data-aria-level=\"1\"><strong>Toric Intraocular Lenses\u00a0<\/strong><\/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=\"13\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559683&quot;:1,&quot;335559684&quot;:-2,&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;hybridMultilevel&quot;}\" data-aria-posinset=\"1\" data-aria-level=\"2\"><span data-contrast=\"auto\">Toric IOLs compensate for corneal astigmatism. From a regulatory perspective, emphasis is placed on rotational stability, axis alignment features, and clinical or bench data\u00a0demonstrating\u00a0astigmatic correction accuracy.<\/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=\"13\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559683&quot;:0,&quot;335559684&quot;:-2,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;\uf0b7&quot;,&quot;469777815&quot;:&quot;hybridMultilevel&quot;}\" data-aria-posinset=\"4\" data-aria-level=\"1\"><strong>Extended Depth of Focus (EDOF) Intraocular Lenses\u00a0<\/strong><\/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=\"13\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559683&quot;:1,&quot;335559684&quot;:-2,&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;hybridMultilevel&quot;}\" data-aria-posinset=\"1\" data-aria-level=\"2\"><span data-contrast=\"auto\">EDOF lenses are intended to extend the range of\u00a0clear vision\u00a0without discrete focal zones. Technical files commonly\u00a0contain\u00a0bench testing and, where applicable, clinical evidence\u00a0demonstrating\u00a0consistent optical performance across multiple distances.<\/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=\"13\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559683&quot;:0,&quot;335559684&quot;:-2,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;\uf0b7&quot;,&quot;469777815&quot;:&quot;hybridMultilevel&quot;}\" data-aria-posinset=\"5\" data-aria-level=\"1\"><strong>Phakic Intraocular Lenses\u00a0<\/strong><\/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=\"13\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559683&quot;:1,&quot;335559684&quot;:-2,&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;hybridMultilevel&quot;}\" data-aria-posinset=\"1\" data-aria-level=\"2\"><span data-contrast=\"auto\">Phakic IOLs are implanted without removing the natural crystalline lens. Due to their placement in anatomically sensitive regions and prolonged intraocular presence, regulatory evaluations typically include\u00a0additional\u00a0considerations related to endothelial cell density, chamber angle interaction, and long<\/span>\u2011<span data-contrast=\"auto\">term ocular safety.<\/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=\"13\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559683&quot;:0,&quot;335559684&quot;:-2,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;\uf0b7&quot;,&quot;469777815&quot;:&quot;hybridMultilevel&quot;}\" data-aria-posinset=\"6\" data-aria-level=\"1\"><strong>Preloaded and Injector\u2011Integrated IOL Systems\u00a0<\/strong><\/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=\"13\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559683&quot;:1,&quot;335559684&quot;:-2,&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;hybridMultilevel&quot;}\" data-aria-posinset=\"1\" data-aria-level=\"2\"><span data-contrast=\"auto\">Some intraocular lenses are marketed in combination with a sterile, single<\/span>\u2011<span data-contrast=\"auto\">use injector. When the injector and lens are supplied as a unified commercial presentation, they are\u00a0generally assessed\u00a0together as a single medical device system.<\/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\">How Are IOLs Classified in\u00a0Colombia?<\/span><\/b><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;201341983&quot;:0,&quot;335551550&quot;:1,&quot;335551620&quot;:1,&quot;335559685&quot;:0,&quot;335559737&quot;:0,&quot;335559738&quot;:0,&quot;335559739&quot;:160,&quot;335559740&quot;:278}\">\u00a0<\/span><\/h3>\n<p><span data-contrast=\"auto\">Under the Colombian medical device framework administered by\u00a0INVIMA,\u00a0classification is\u00a0determined\u00a0by invasiveness, duration of use, and interaction with the human body.<\/span><span data-ccp-props=\"{}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">In accordance with\u00a0Colombian rules, all implantable medical devices and long<\/span>\u2011<span data-contrast=\"auto\">term surgically invasive medical devices are assigned to <strong>Class IIb<\/strong>. As a result:<\/span><span data-ccp-props=\"{}\">\u00a0<\/span><\/p>\n<ul>\n<li data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"14\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559683&quot;:0,&quot;335559684&quot;:-2,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;\uf0b7&quot;,&quot;469777815&quot;:&quot;hybridMultilevel&quot;}\" data-aria-posinset=\"1\" data-aria-level=\"1\"><span data-contrast=\"auto\">Standard cataract IOLs are classified as <strong>Class IIb<\/strong> medical devices\u00a0due to permanent implantation.<\/span><span data-ccp-props=\"{}\">\u00a0<\/span><\/li>\n<\/ul>\n<ul>\n<li data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"14\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559683&quot;:0,&quot;335559684&quot;:-2,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;\uf0b7&quot;,&quot;469777815&quot;:&quot;hybridMultilevel&quot;}\" data-aria-posinset=\"2\" data-aria-level=\"1\"><span data-contrast=\"auto\">Phakic intraocular lenses are also regulated as <strong>Class IIb<\/strong>, reflecting their sustained intraocular presence.<\/span><span data-ccp-props=\"{}\">\u00a0<\/span><\/li>\n<\/ul>\n<p><span data-ccp-props=\"{}\">\u00a0<\/span><\/p>\n<h3><b><span data-contrast=\"auto\">Grouping Criteria for IOL Sanitary Registrations<\/span><\/b><span data-ccp-props=\"{}\">\u00a0<\/span><\/h3>\n<p><span data-contrast=\"auto\">Manufacturers may group multiple IOL models under a single registration when they share core design and performance attributes. In\u00a0Colombia, grouping\u00a0is\u00a0permitted\u00a0when the following criteria are met:<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;201341983&quot;:0,&quot;335551550&quot;:1,&quot;335551620&quot;:1,&quot;335559685&quot;:0,&quot;335559737&quot;:0,&quot;335559738&quot;:0,&quot;335559739&quot;:160,&quot;335559740&quot;:278}\">\u00a0<\/span><\/p>\n<ol>\n<li><b><span data-contrast=\"auto\">Same Manufacturer<\/span><\/b><span data-ccp-props=\"{}\">\u00a0<\/span><\/li>\n<\/ol>\n<p><span data-contrast=\"auto\">All variants must originate from the same legal manufacturer or facility listed in the quality\u00a0system\u00a0documentation.<\/span><span data-ccp-props=\"{}\">\u00a0<\/span><\/p>\n<ol start=\"2\">\n<li><b><span data-contrast=\"auto\"> Same Commercial Name (Family or Series)<\/span><\/b><\/li>\n<\/ol>\n<p><span data-contrast=\"auto\">Grouping is\u00a0permitted\u00a0when the IOLs belong to a consistent product line or family with a unified brand or commercial designation.<\/span><span data-ccp-props=\"{}\">\u00a0<\/span><\/p>\n<ol start=\"3\">\n<li><b><span data-contrast=\"auto\"> Same Intended Use<\/span><\/b><\/li>\n<\/ol>\n<p><span data-contrast=\"auto\">The lenses must share the same therapeutic purpose (e.g., visual rehabilitation following cataract extraction). Variants designed for different indications,\u00a0such as phakic use,\u00a0may require separate registrations.<\/span><span data-ccp-props=\"{}\">\u00a0<\/span><\/p>\n<ol start=\"4\">\n<li><b><span data-contrast=\"auto\"> Same Technology Platform<\/span><\/b><\/li>\n<\/ol>\n<p><span data-contrast=\"auto\">This refers to consistency in:<\/span><span data-ccp-props=\"{}\">\u00a0<\/span><\/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\"><span data-contrast=\"auto\">Base\u00a0optical\u00a0design\u00a0(monofocal, multifocal, EDOF,\u00a0toric)<\/span><span data-ccp-props=\"{}\">\u00a0<\/span><\/li>\n<\/ul>\n<ul>\n<li data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"2\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;\uf0b7&quot;,&quot;469777815&quot;:&quot;multilevel&quot;}\" data-aria-posinset=\"2\" data-aria-level=\"1\"><span data-contrast=\"auto\">Material type (hydrophobic acrylic, hydrophilic acrylic, silicone)<\/span><span data-ccp-props=\"{}\">\u00a0<\/span><\/li>\n<\/ul>\n<ul>\n<li data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"2\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;\uf0b7&quot;,&quot;469777815&quot;:&quot;multilevel&quot;}\" data-aria-posinset=\"3\" data-aria-level=\"1\"><span data-contrast=\"auto\">Haptic configuration (C<\/span>\u2011<span data-contrast=\"auto\">loop, plate haptic)<\/span><span data-ccp-props=\"{}\">\u00a0<\/span><\/li>\n<\/ul>\n<ul>\n<li data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"2\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;\uf0b7&quot;,&quot;469777815&quot;:&quot;multilevel&quot;}\" data-aria-posinset=\"4\" data-aria-level=\"1\"><span data-contrast=\"auto\">Delivery platform when part of a preloaded system<\/span><span data-ccp-props=\"{}\">\u00a0<\/span><\/li>\n<\/ul>\n<p><span data-contrast=\"auto\">Significant changes in optical mechanism (e.g.,\u00a0monofocal\u00a0vs. multifocal) or material formulation typically prevent grouping under a single registration.<\/span><span data-ccp-props=\"{}\">\u00a0<\/span><\/p>\n<ol start=\"5\">\n<li><b><span data-contrast=\"auto\"> Variants Allowed Within a Group<\/span><\/b><\/li>\n<\/ol>\n<p><span data-contrast=\"auto\">Changes such as diopter range, haptic length, optic diameter, and minor injector modifications may be included if they do not alter the fundamental functioning or risk profile.<\/span><span data-ccp-props=\"{}\">\u00a0<\/span><\/p>\n<p><span data-ccp-props=\"{}\">\u00a0<\/span><\/p>\n<h3><b><span data-contrast=\"auto\">Frequently Asked Questions (FAQ)<\/span><\/b><span data-ccp-props=\"{}\">\u00a0<\/span><\/h3>\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;hybridMultilevel&quot;}\" data-aria-posinset=\"1\" data-aria-level=\"1\"><b><span data-contrast=\"auto\">What is an intraocular lens (IOL)?<\/span><\/b><span data-ccp-props=\"{}\"><br \/>\n<\/span>An intraocular lens is a small artificial lens placed inside the eye, usually during cataract surgery, to help restore\u00a0clear vision.<span data-ccp-props=\"{&quot;335559685&quot;:720}\"><\/p>\n<p><\/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;hybridMultilevel&quot;}\" data-aria-posinset=\"1\" data-aria-level=\"1\"><b><span data-contrast=\"auto\">Why are IOLs classified as Class IIb in Colombia?<\/span><\/b><br \/>\n<span data-contrast=\"auto\">Because they are implantable and remain in the body long term, they fall under Class IIb according to Colombian medical device classification rules.<\/span><span data-ccp-props=\"{}\"><\/p>\n<p><\/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;hybridMultilevel&quot;}\" data-aria-posinset=\"1\" data-aria-level=\"1\"><b><span data-contrast=\"auto\">Can different IOL models be grouped under the same registration?<\/span><\/b><span data-ccp-props=\"{}\"><br \/>\n<\/span>They can,\u00a0as long as\u00a0they belong to the same product family and share similar materials, design concepts, and intended use.<span data-ccp-props=\"{&quot;335559685&quot;:720}\">\u00a0<\/span><\/li>\n<\/ol>\n<p><span data-ccp-props=\"{}\">\u00a0<\/span><\/p>\n<h3><b><span data-contrast=\"auto\">Conclusion<\/span><\/b><span data-ccp-props=\"{}\">\u00a0<\/span><\/h3>\n<p>In Colombia, intraocular lenses are regulated as Class IIb medical devices due to their implantable nature and long\u2011term intraocular use. A clear understanding of INVIMA classification rules and grouping principles supports efficient regulatory planning, facilitates cohesive product family submissions, and helps align technical documentation with national market authorization requirements.<\/p>\n<p><a href=\"mailto:contact@veraqueconsulting.com\"><b><span data-contrast=\"none\">Partner with\u202fVeraque<\/span><\/b><\/a><b><span data-contrast=\"auto\">\u202f<\/span><\/b><span data-contrast=\"auto\">for clear, tailored guidance through\u00a0INVIMA\u2019s\u00a0regulatory landscape.\u202f<\/span><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Intraocular lenses (IOLs) are\u00a0implantable\u00a0ophthalmic medical devices designed to replace the eye\u2019s natural crystalline lens during cataract extraction or elective refractive procedures. Factors such as optical architecture, biomaterials, and implantation method not only influence clinical performance but also\u00a0determine\u00a0the applicable regulatory pathway in Colombia.\u00a0 \u00a0 This article reviews the principal categories of intraocular lenses, their regulatory classification [&hellip;]<\/p>\n","protected":false},"author":6,"featured_media":3377,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[367,396],"tags":[],"class_list":["post-3376","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>Intraocular Lenses (IOLs): Classification and Grouping in Colombia - Veraque Colombia<\/title>\n<meta name=\"description\" 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