{"id":4513,"date":"2024-08-27T14:59:43","date_gmt":"2024-08-27T19:59:43","guid":{"rendered":"https:\/\/scrconsultings.com\/?p=4513"},"modified":"2026-01-27T12:48:45","modified_gmt":"2026-01-27T17:48:45","slug":"medical-device-risk-classification-peru-chile-bolivia","status":"publish","type":"post","link":"https:\/\/scrconsultings.com\/es\/medical-device-risk-classification-peru-chile-bolivia\/","title":{"rendered":"Clasificaci\u00f3n de Dispositivos M\u00e9dicos en Per\u00fa, Bolivia y Chile"},"content":{"rendered":"<p class=\"translation-block\"><strong>En Per\u00fa y Chile<\/strong>, los dispositivos m\u00e9dicos se clasifican seg\u00fan el potencial o los riesgos residuales asociados a su uso. Esta clasificaci\u00f3n considera criterios como la duraci\u00f3n del contacto con el cuerpo, el grado de invasividad y los efectos locales y sist\u00e9micos. Pr\u00e1cticamente, los dispositivos se agrupan por el nivel de riesgo que presentan, categorizados en:<\/p>\n<ul>\n<li class=\"translation-block\"><strong>Clase I<\/strong> : Bajo riesgo.<\/li>\n<li class=\"translation-block\"><strong>Clase II:<\/strong> Riesgo moderado.<\/li>\n<li class=\"translation-block\"><strong>Clase III<\/strong> : Alto riesgo.<\/li>\n<li class=\"translation-block\"><strong>Clase IV<\/strong>: Riesgo muy alto.<\/li>\n<\/ul>\n<p class=\"translation-block\"><strong>Bolivia<\/strong>: En Bolivia, la clasificaci\u00f3n de dispositivos m\u00e9dicos se basa en los riesgos potenciales relacionados con su uso y posibles fallos del dispositivo, considerando m\u00faltiples criterios como la duraci\u00f3n del contacto con el cuerpo, el grado de invasividad y los efectos locales versus sist\u00e9micos. En alineaci\u00f3n con acuerdos internacionales para establecer regulaciones armonizadas, se ha adoptado este sistema de clasificaci\u00f3n, exigiendo a las empresas que clasifiquen cada dispositivo m\u00e9dico seg\u00fan su prop\u00f3sito previsto.<\/p>\n<ul>\n<li class=\"translation-block\"><strong>Clase I:<\/strong> Dispositivos de bajo riesgo sujetos a controles generales, que no est\u00e1n destinados a proteger o sostener la vida, ni para uso especial en la prevenci\u00f3n del deterioro de la salud humana, y que no presentan un riesgo irracional de enfermedad o lesi\u00f3n.<\/li>\n<li class=\"translation-block\"><strong>Clase IIa:<\/strong>: Dispositivos de riesgo moderado sujetos a controles especiales durante la fase de fabricaci\u00f3n para demostrar su seguridad y eficacia.<\/li>\n<li class=\"translation-block\"><strong>Clase IIb:<\/strong> Dispositivos de alto riesgo sujetos a controles especiales durante el dise\u00f1o y la fabricaci\u00f3n para demostrar su seguridad y eficacia.<\/li>\n<li class=\"translation-block\"><strong>Clase III:<\/strong> Dispositivos de riesgo muy alto sujetos a controles especiales, destinados a proteger o sostener la vida, para uso significativo en la prevenci\u00f3n del deterioro de la salud humana, o si su uso conlleva un riesgo potencial de enfermedad o lesi\u00f3n.<\/li>\n<\/ul>","protected":false},"excerpt":{"rendered":"<p>In Peru and Chile, medical devices are classified based on the potential or residual risks associated with their use. This classification considers criteria such as the duration of body contact, the degree of invasiveness, and both local and systemic effects. Practically, devices are grouped by the level of risk they present, categorized into: Class I: [&hellip;]<\/p>\n","protected":false},"author":4,"featured_media":4599,"comment_status":"closed","ping_status":"open","sticky":false,"template":"elementor_theme","format":"standard","meta":{"footnotes":""},"categories":[46,79],"tags":[],"class_list":["post-4513","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-blog","category-medical-devices"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v28.5 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Medical Device Risk Classes in Peru, Chile &amp; Bolivia<\/title>\n<meta name=\"description\" content=\"Understand medical device risk classification in Peru, Chile and Bolivia, including Classes I\u2013IV and IIa\/IIb, and the key criteria used by regulators.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, 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