{"id":3738,"date":"2025-08-28T14:51:08","date_gmt":"2025-08-28T14:51:08","guid":{"rendered":"https:\/\/nietolawyersregulatorioysanitario.com\/en\/?post_type=actualidad&#038;p=3738"},"modified":"2025-08-28T14:54:17","modified_gmt":"2025-08-28T14:54:17","slug":"does-your-company-import-manufacture-or-distribute-class-iii-iib-medical-devices-in-colombia","status":"publish","type":"actualidad","link":"https:\/\/nietolawyersregulatorioysanitario.com\/en\/actualidad\/does-your-company-import-manufacture-or-distribute-class-iii-iib-medical-devices-in-colombia\/","title":{"rendered":"Does your company import, manufacture, or distribute Class III\u2013IIb medical devices in Colombia?"},"content":{"rendered":"\n<figure class=\"wp-block-image size-large\"><img fetchpriority=\"high\" decoding=\"async\" width=\"1024\" height=\"585\" src=\"https:\/\/nietolawyersregulatorioysanitario.com\/wp-content\/uploads\/2025\/07\/Firefly_Mechanical-ventilator-next-to-a-hospital-bed-in-an-intensive-care-unit.-Clean-sterile-279374-1024x585.jpg\" alt=\"\" class=\"wp-image-3587\" srcset=\"https:\/\/nietolawyersregulatorioysanitario.com\/en\/wp-content\/uploads\/2025\/07\/Firefly_Mechanical-ventilator-next-to-a-hospital-bed-in-an-intensive-care-unit.-Clean-sterile-279374-1024x585.jpg 1024w, https:\/\/nietolawyersregulatorioysanitario.com\/en\/wp-content\/uploads\/2025\/07\/Firefly_Mechanical-ventilator-next-to-a-hospital-bed-in-an-intensive-care-unit.-Clean-sterile-279374-300x171.jpg 300w, https:\/\/nietolawyersregulatorioysanitario.com\/en\/wp-content\/uploads\/2025\/07\/Firefly_Mechanical-ventilator-next-to-a-hospital-bed-in-an-intensive-care-unit.-Clean-sterile-279374-768x439.jpg 768w, https:\/\/nietolawyersregulatorioysanitario.com\/en\/wp-content\/uploads\/2025\/07\/Firefly_Mechanical-ventilator-next-to-a-hospital-bed-in-an-intensive-care-unit.-Clean-sterile-279374-1536x878.jpg 1536w, https:\/\/nietolawyersregulatorioysanitario.com\/en\/wp-content\/uploads\/2025\/07\/Firefly_Mechanical-ventilator-next-to-a-hospital-bed-in-an-intensive-care-unit.-Clean-sterile-279374-2048x1170.jpg 2048w\" sizes=\"(max-width: 1024px) 100vw, 1024px\" \/><\/figure>\n\n\n\n<p>Since 2024, INVIMA has required full compliance with the semantic standard for these products \u2014 yet over 85% of registrations have not reported their UDI-DI codes and other required attributes. Time is running out, and penalties are coming. Here we explain exactly what INVIMA requires, how to do it right, and how to avoid costly mistakes.<br><\/p>\n\n\n\n<div class=\"wp-block-esab-accordion esab-7bwe9rlr\" data-mode=\"global\"><div class=\"esab__container\">\n<div class=\"wp-block-esab-accordion-child\"><div class=\"esab__head\" role=\"button\" aria-expanded=\"false\"><div class=\"esab__heading_txt\"><p class=\"esab__heading_tag\"><strong>1. What is a Class IIb medical device?<\/strong><\/p><\/div><div class=\"esab__icon\"><div class=\"esab__collapse\"> <svg version=\"1.2\" viewBox=\"0 0 24 24\" width=\"24\" height=\"24\"><path fill-rule=\"evenodd\" d=\"m3.5 20.5c-4.7-4.7-4.7-12.3 0-17 4.7-4.7 12.3-4.7 17 0 4.6 4.7 4.6 12.3 0 17-4.7 4.6-12.3 4.6-17 0zm0.9-0.9c4.2 4.2 11 4.2 15.2 0 4.2-4.2 4.2-11 0-15.2-4.2-4.3-11-4.3-15.2 0-4.3 4.2-4.3 11 0 15.2z\"><\/path><path d=\"m11.4 15.9v-3.3h-3.3c-0.3 0-0.6-0.3-0.6-0.6 0-0.4 0.3-0.6 0.6-0.6h3.3v-3.3c0-0.3 0.3-0.6 0.6-0.6 0.3 0 0.6 0.3 0.6 0.6v3.3h3.3c0.3 0 0.6 0.2 0.6 0.6q0 0.2-0.2 0.4-0.2 0.2-0.4 0.2h-3.3v3.3q0 0.2-0.2 0.4-0.2 0.2-0.4 0.2c-0.4 0-0.6-0.3-0.6-0.6z\"><\/path><\/svg> <\/div><div class=\"esab__expand\"> <svg version=\"1.2\" viewBox=\"0 0 24 24\" width=\"24\" height=\"24\"><path fill-rule=\"evenodd\" d=\"m12 24c-6.6 0-12-5.4-12-12 0-6.6 5.4-12 12-12 6.6 0 12 5.4 12 12 0 6.6-5.4 12-12 12zm10.6-12c0-5.9-4.7-10.6-10.6-10.6-5.9 0-10.6 4.7-10.6 10.6 0 5.9 4.7 10.6 10.6 10.6 5.9 0 10.6-4.7 10.6-10.6z\"><\/path><path d=\"m5.6 11.3h12.8v1.4h-12.8z\"><\/path><\/svg> <\/div><\/div><\/div><div class=\"esab__body\">\n<p>Under INVIMA\u2019s classification system, Class IIb devices are medium- to high-risk products such as catheters, infusion pumps, monitoring systems, ventilators, and non-permanent implants. Their risk level requires stricter regulatory control and more comprehensive technical documentation.<\/p>\n<\/div><\/div>\n\n\n\n<div class=\"wp-block-esab-accordion-child\"><div class=\"esab__head\" role=\"button\" aria-expanded=\"false\"><div class=\"esab__heading_txt\"><p class=\"esab__heading_tag\"><strong>2. What does INVIMA require for Class IIb devices in 2025?<\/strong><\/p><\/div><div class=\"esab__icon\"><div class=\"esab__collapse\"> <svg version=\"1.2\" viewBox=\"0 0 24 24\" width=\"24\" height=\"24\"><path fill-rule=\"evenodd\" d=\"m3.5 20.5c-4.7-4.7-4.7-12.3 0-17 4.7-4.7 12.3-4.7 17 0 4.6 4.7 4.6 12.3 0 17-4.7 4.6-12.3 4.6-17 0zm0.9-0.9c4.2 4.2 11 4.2 15.2 0 4.2-4.2 4.2-11 0-15.2-4.2-4.3-11-4.3-15.2 0-4.3 4.2-4.3 11 0 15.2z\"><\/path><path d=\"m11.4 15.9v-3.3h-3.3c-0.3 0-0.6-0.3-0.6-0.6 0-0.4 0.3-0.6 0.6-0.6h3.3v-3.3c0-0.3 0.3-0.6 0.6-0.6 0.3 0 0.6 0.3 0.6 0.6v3.3h3.3c0.3 0 0.6 0.2 0.6 0.6q0 0.2-0.2 0.4-0.2 0.2-0.4 0.2h-3.3v3.3q0 0.2-0.2 0.4-0.2 0.2-0.4 0.2c-0.4 0-0.6-0.3-0.6-0.6z\"><\/path><\/svg> <\/div><div class=\"esab__expand\"> <svg version=\"1.2\" viewBox=\"0 0 24 24\" width=\"24\" height=\"24\"><path fill-rule=\"evenodd\" d=\"m12 24c-6.6 0-12-5.4-12-12 0-6.6 5.4-12 12-12 6.6 0 12 5.4 12 12 0 6.6-5.4 12-12 12zm10.6-12c0-5.9-4.7-10.6-10.6-10.6-5.9 0-10.6 4.7-10.6 10.6 0 5.9 4.7 10.6 10.6 10.6 5.9 0 10.6-4.7 10.6-10.6z\"><\/path><path d=\"m5.6 11.3h12.8v1.4h-12.8z\"><\/path><\/svg> <\/div><\/div><\/div><div class=\"esab__body\">\n<p>As of July 1, 2025, INVIMA has reiterated the following key requirements to maintain authorization for marketing Class IIb medical devices in Colombia:<\/p>\n\n\n\n<ol class=\"wp-block-list\">\n<li>Properly reported semantic standard<br>\n<ul class=\"wp-block-list\">\n<li>This is both a technical and legal requirement.<br><\/li>\n\n\n\n<li>Submitted through INVIMA\u2019s medical device coding platform.<br><\/li>\n\n\n\n<li>Must use standardized terminology and structures defined by the Global Medical Device Nomenclature (GMDN).<br><\/li>\n<\/ul>\n<\/li>\n\n\n\n<li>Updated technical and labeling data<br>\n<ul class=\"wp-block-list\">\n<li>Manuals, technical sheets, and labels must align with the standard.<br><\/li>\n\n\n\n<li>Avoid ambiguous or generic terms.<br><\/li>\n<\/ul>\n<\/li>\n\n\n\n<li>Documentary support and traceability<br>\n<ul class=\"wp-block-list\">\n<li>Your registration must be backed by technical documentation, validations, certifications, clinical trials, or biocompatibility tests (as applicable).<br><\/li>\n<\/ul>\n<\/li>\n\n\n\n<li>Manufacturer and origin validation<br>\n<ul class=\"wp-block-list\">\n<li>All manufacturer documents must be legalized and up to date.<br><\/li>\n<\/ul>\n<\/li>\n<\/ol>\n\n\n\n<p>Product origin must match what was reported to INVIMA.<\/p>\n<\/div><\/div>\n\n\n\n<div class=\"wp-block-esab-accordion-child\"><div class=\"esab__head\" role=\"button\" aria-expanded=\"false\"><div class=\"esab__heading_txt\"><p class=\"esab__heading_tag\"><strong>3. What happens if you do not comply?<\/strong><\/p><\/div><div class=\"esab__icon\"><div class=\"esab__collapse\"> <svg version=\"1.2\" viewBox=\"0 0 24 24\" width=\"24\" height=\"24\"><path fill-rule=\"evenodd\" d=\"m3.5 20.5c-4.7-4.7-4.7-12.3 0-17 4.7-4.7 12.3-4.7 17 0 4.6 4.7 4.6 12.3 0 17-4.7 4.6-12.3 4.6-17 0zm0.9-0.9c4.2 4.2 11 4.2 15.2 0 4.2-4.2 4.2-11 0-15.2-4.2-4.3-11-4.3-15.2 0-4.3 4.2-4.3 11 0 15.2z\"><\/path><path d=\"m11.4 15.9v-3.3h-3.3c-0.3 0-0.6-0.3-0.6-0.6 0-0.4 0.3-0.6 0.6-0.6h3.3v-3.3c0-0.3 0.3-0.6 0.6-0.6 0.3 0 0.6 0.3 0.6 0.6v3.3h3.3c0.3 0 0.6 0.2 0.6 0.6q0 0.2-0.2 0.4-0.2 0.2-0.4 0.2h-3.3v3.3q0 0.2-0.2 0.4-0.2 0.2-0.4 0.2c-0.4 0-0.6-0.3-0.6-0.6z\"><\/path><\/svg> <\/div><div class=\"esab__expand\"> <svg version=\"1.2\" viewBox=\"0 0 24 24\" width=\"24\" height=\"24\"><path fill-rule=\"evenodd\" d=\"m12 24c-6.6 0-12-5.4-12-12 0-6.6 5.4-12 12-12 6.6 0 12 5.4 12 12 0 6.6-5.4 12-12 12zm10.6-12c0-5.9-4.7-10.6-10.6-10.6-5.9 0-10.6 4.7-10.6 10.6 0 5.9 4.7 10.6 10.6 10.6 5.9 0 10.6-4.7 10.6-10.6z\"><\/path><path d=\"m5.6 11.3h12.8v1.4h-12.8z\"><\/path><\/svg> <\/div><\/div><\/div><div class=\"esab__body\">\n<ul class=\"wp-block-list\">\n<li>Loss of the sanitary registration<br><\/li>\n\n\n\n<li>Financial penalties<br><\/li>\n\n\n\n<li>Temporary ban on commercialization<br><\/li>\n\n\n\n<li>Reputational damage with clients, distributors, and tenders<\/li>\n<\/ul>\n<\/div><\/div>\n\n\n\n<div class=\"wp-block-esab-accordion-child\"><div class=\"esab__head\" role=\"button\" aria-expanded=\"false\"><div class=\"esab__heading_txt\"><p class=\"esab__heading_tag\"><strong>4. How can you check if your device has reported the standard?<\/strong><\/p><\/div><div class=\"esab__icon\"><div class=\"esab__collapse\"> <svg version=\"1.2\" viewBox=\"0 0 24 24\" width=\"24\" height=\"24\"><path fill-rule=\"evenodd\" d=\"m3.5 20.5c-4.7-4.7-4.7-12.3 0-17 4.7-4.7 12.3-4.7 17 0 4.6 4.7 4.6 12.3 0 17-4.7 4.6-12.3 4.6-17 0zm0.9-0.9c4.2 4.2 11 4.2 15.2 0 4.2-4.2 4.2-11 0-15.2-4.2-4.3-11-4.3-15.2 0-4.3 4.2-4.3 11 0 15.2z\"><\/path><path d=\"m11.4 15.9v-3.3h-3.3c-0.3 0-0.6-0.3-0.6-0.6 0-0.4 0.3-0.6 0.6-0.6h3.3v-3.3c0-0.3 0.3-0.6 0.6-0.6 0.3 0 0.6 0.3 0.6 0.6v3.3h3.3c0.3 0 0.6 0.2 0.6 0.6q0 0.2-0.2 0.4-0.2 0.2-0.4 0.2h-3.3v3.3q0 0.2-0.2 0.4-0.2 0.2-0.4 0.2c-0.4 0-0.6-0.3-0.6-0.6z\"><\/path><\/svg> <\/div><div class=\"esab__expand\"> <svg version=\"1.2\" viewBox=\"0 0 24 24\" width=\"24\" height=\"24\"><path fill-rule=\"evenodd\" d=\"m12 24c-6.6 0-12-5.4-12-12 0-6.6 5.4-12 12-12 6.6 0 12 5.4 12 12 0 6.6-5.4 12-12 12zm10.6-12c0-5.9-4.7-10.6-10.6-10.6-5.9 0-10.6 4.7-10.6 10.6 0 5.9 4.7 10.6 10.6 10.6 5.9 0 10.6-4.7 10.6-10.6z\"><\/path><path d=\"m5.6 11.3h12.8v1.4h-12.8z\"><\/path><\/svg> <\/div><\/div><\/div><div class=\"esab__body\">\n<p>You can verify your registration status on INVIMA\u2019s official portal:<\/p>\n\n\n\n<p><a href=\"https:\/\/www.invima.gov.co\/productos-vigilados\/dispositivos-medicos\/estandar-semantico-y-codificacion-de-dispositivos-medicos\">Sanitary Registration Status Check \u2013 INVIMA<\/a><\/p>\n<\/div><\/div>\n<\/div><\/div>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>Real Case<\/strong><\/h2>\n\n\n\n<figure class=\"wp-block-image size-large\"><img decoding=\"async\" width=\"1024\" height=\"585\" src=\"https:\/\/nietolawyersregulatorioysanitario.com\/wp-content\/uploads\/2025\/07\/Firefly_Sterile-catheter-in-transparent-medical-packaging-placed-on-a-stainless-steel-surgic-59319-1024x585.jpg\" alt=\"\" class=\"wp-image-3588\" srcset=\"https:\/\/nietolawyersregulatorioysanitario.com\/en\/wp-content\/uploads\/2025\/07\/Firefly_Sterile-catheter-in-transparent-medical-packaging-placed-on-a-stainless-steel-surgic-59319-1024x585.jpg 1024w, https:\/\/nietolawyersregulatorioysanitario.com\/en\/wp-content\/uploads\/2025\/07\/Firefly_Sterile-catheter-in-transparent-medical-packaging-placed-on-a-stainless-steel-surgic-59319-300x171.jpg 300w, https:\/\/nietolawyersregulatorioysanitario.com\/en\/wp-content\/uploads\/2025\/07\/Firefly_Sterile-catheter-in-transparent-medical-packaging-placed-on-a-stainless-steel-surgic-59319-768x439.jpg 768w, https:\/\/nietolawyersregulatorioysanitario.com\/en\/wp-content\/uploads\/2025\/07\/Firefly_Sterile-catheter-in-transparent-medical-packaging-placed-on-a-stainless-steel-surgic-59319-1536x878.jpg 1536w, https:\/\/nietolawyersregulatorioysanitario.com\/en\/wp-content\/uploads\/2025\/07\/Firefly_Sterile-catheter-in-transparent-medical-packaging-placed-on-a-stainless-steel-surgic-59319-2048x1170.jpg 2048w\" sizes=\"(max-width: 1024px) 100vw, 1024px\" \/><\/figure>\n\n\n\n<p>A company with four Class IIb registrations had not reported the semantic standard. INVIMA issued formal requirements. With the support of Nieto Lawyers, all documentation was updated in just 15 days, avoiding penalties. The company was able to participate again in public tenders in 2025.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>Why work with both legal and technical advisors?<\/strong><\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li>INVIMA\u2019s technical and legal language can be complex.<\/li>\n\n\n\n<li>Reporting the standard is not just \u201cuploading a file.\u201d<\/li>\n\n\n\n<li> Every mistake costs time \u2014 and time is money.<\/li>\n\n\n\n<li>The right guidance prevents rework and penalties.<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\">Not sure if your device is compliant?<\/h3>\n\n\n\n<p>At Nieto Lawyers, we offer a free review of your regulatory compliance status.<\/p>\n\n\n\n<a \n  href=\"https:\/\/api.whatsapp.com\/send?phone=573156695219&#038;text=Hola!%20requiero%20servicios%20legales\" \n  target=\"_blank\" \n  rel=\"noopener noreferrer\" \n  style=\"\n    display: inline-flex;\n    align-items: center;\n    background-color: #25D366;\n    color: white;\n    padding: 10px 20px;\n    border-radius: 25px;\n    text-decoration: none;\n    font-weight: bold;\n    font-family: sans-serif;\n    box-shadow: 0 4px 6px rgba(0,0,0,0.1);\n    transition: background-color 0.3s ease;\n  \"\n  onmouseover=\"this.style.backgroundColor='#1ebe57'\"\n  onmouseout=\"this.style.backgroundColor='#25D366'\"\n>\n  <svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" style=\"margin-right: 10px;\" width=\"20\" height=\"20\" fill=\"white\" viewBox=\"0 0 32 32\">\n    <path d=\"M16.002 2.002C8.824 2.002 2.998 7.828 2.998 15.006a12.937 12.937 0 001.926 6.77L2 30l8.523-2.89a12.97 12.97 0 005.478 1.216h.001c7.178 0 13.004-5.826 13.004-13.004.001-7.177-5.826-13.004-13.004-13.004zm0 23.9a10.923 10.923 0 01-5.574-1.523l-.397-.234-5.06 1.717 1.674-4.93-.259-.418a10.901 10.901 0 01-1.704-5.854c0-6.03 4.91-10.94 10.94-10.94 6.03 0 10.94 4.91 10.94 10.94 0 6.03-4.91 10.94-10.94 10.94zm6.073-8.258c-.334-.167-1.973-.974-2.279-1.085-.306-.112-.528-.167-.75.168-.222.334-.86 1.084-1.055 1.306-.195.223-.389.25-.723.083-.334-.167-1.409-.52-2.683-1.657-.992-.885-1.662-1.977-1.857-2.31-.195-.334-.021-.514.146-.681.15-.149.334-.389.5-.584.167-.195.223-.334.334-.556.111-.223.056-.417-.028-.584-.084-.167-.75-1.805-1.027-2.478-.271-.653-.548-.564-.75-.574l-.641-.012c-.222 0-.584.084-.89.417-.306.334-1.167 1.14-1.167 2.777s1.194 3.22 1.361 3.444c.167.223 2.351 3.586 5.7 5.027.796.343 1.417.548 1.901.701.798.254 1.525.218 2.099.132.64-.095 1.973-.807 2.25-1.586.278-.779.278-1.446.195-1.586-.084-.139-.306-.222-.64-.389z\"\/>\n  <\/svg>\n  WhatsApp\n<\/a>\n\n\n\n<p>Or message us directly on WhatsApp for an express consultation.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Since 2024, INVIMA has required full compliance with the semantic standard for these products \u2014 yet over 85% of registrations have not reported their UDI-DI codes and other required attributes. Time is running out, and penalties are coming. Here we explain exactly what INVIMA requires, how to do it right, and how to avoid costly [&hellip;]<\/p>\n","protected":false},"featured_media":3586,"template":"","meta":[],"categoria":[],"class_list":["post-3738","actualidad","type-actualidad","status-publish","has-post-thumbnail","hentry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.4 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Does your company import, manufacture, or distribute Class III\u2013IIb medical devices in Colombia? - Nieto &amp; Nieto Lawyers<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/nietolawyersregulatorioysanitario.com\/en\/actualidad\/does-your-company-import-manufacture-or-distribute-class-iii-iib-medical-devices-in-colombia\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Does your company import, manufacture, or distribute Class III\u2013IIb medical devices in Colombia? - Nieto &amp; Nieto Lawyers\" \/>\n<meta property=\"og:description\" content=\"Since 2024, INVIMA has required full compliance with the semantic standard for these products \u2014 yet over 85% of registrations have not reported their UDI-DI codes and other required attributes. 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