{"id":1473,"date":"2026-09-24T17:57:13","date_gmt":"2026-09-24T17:57:13","guid":{"rendered":"https:\/\/izzomed.com\/?page_id=1473"},"modified":"2026-10-06T00:20:41","modified_gmt":"2026-10-06T00:20:41","slug":"registro-de-diagnosticos-in-vitro-en-peru","status":"publish","type":"page","link":"https:\/\/izzomed.com\/es\/ivd-registration-in-peru\/","title":{"rendered":"Registro de productos sanitarios in vitro en Per\u00fa"},"content":{"rendered":"<style type=\"text\/css\">.izzo-ivd{font-family:inherit;color:#17365f;overflow:hidden}.izzo-ivd *{box-sizing:border-box}.izzo-ivd .hero{max-width:1200px;margin:0 auto 64px;padding:76px 64px;border-radius:0 0 34px 34px;background:linear-gradient(110deg,#f5f9fd 0%,#eef7fb 55%,#d8edf5 100%);position:relative}.izzo-ivd .eyebrow{color:#1396b8;font-weight:800;letter-spacing:.12em;text-transform:uppercase;font-size:13px}.izzo-ivd h1{color:#173b72;font-size:52px;line-height:1.05;margin:14px 0 18px;font-weight:800;max-width:720px}.izzo-ivd .hero 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.dark{background:linear-gradient(135deg,#092f66,#124f87);padding:52px;border-radius:28px}.izzo-ivd .dark h2,.izzo-ivd .dark p,.izzo-ivd .dark h3{color:#fff}.izzo-ivd .dark .card{background:rgba(255,255,255,.08);border-color:rgba(255,255,255,.16);box-shadow:none}.izzo-ivd .cta{max-width:1120px;margin:0 auto 78px;padding:52px 55px;background:linear-gradient(135deg,#123f82,#087e9e);border-radius:28px;text-align:center}.izzo-ivd .cta h2,.izzo-ivd .cta p{color:#fff}.izzo-ivd .btn{display:inline-block;background:#fff;color:#123f82!important;text-decoration:none;padding:14px 24px;border-radius:10px;font-weight:800}.izzo-ivd a{color:#087e9e}@media(max-width:900px){.izzo-ivd .grid,.izzo-ivd .hero-badges{grid-template-columns:1fr 1fr}.izzo-ivd .steps{grid-template-columns:1fr 1fr}.izzo-ivd .split{grid-template-columns:1fr}}@media(max-width:600px){.izzo-ivd .hero{padding:48px 24px}.izzo-ivd h1{font-size:38px}.izzo-ivd .grid,.izzo-ivd .steps,.izzo-ivd .hero-badges{grid-template-columns:1fr}.izzo-ivd .panel,.izzo-ivd .cta,.izzo-ivd .dark{padding:32px 24px}}<\/style>\n<div class=\"izzo-ivd\">\n<section class=\"hero\">\n<div class=\"eyebrow\">Servicios regulatorios de diagn\u00f3stico in vitro<\/div>\n<h1>Registro de productos sanitarios in vitro en Per\u00fa<\/h1>\n<p><strong>Consultor\u00eda regulatoria de productos de diagn\u00f3stico in vitro en Per\u00fa<\/strong> para fabricantes internacionales que buscan registrar dispositivos m\u00e9dicos de diagn\u00f3stico in vitro con <a href=\"https:\/\/izzomed.com\/es\/digemid-peru\/\">DIGEMID<\/a> y entrar en el mercado sanitario peruano.<\/p>\n<p><a class=\"btn\" href=\"https:\/\/izzomed.com\/es\/contacto\/\">CONTACTA CON NUESTRO EQUIPO \u2192<\/a><\/p>\n<div class=\"hero-badges\">\n<div class=\"badge\"><strong>Experiencia en DIGEMID<\/strong>Apoyo regulatorio local en Per\u00fa<\/div>\n<div class=\"badge\"><strong>Soporte integral<\/strong>Desde la evaluaci\u00f3n hasta el seguimiento regulatorio<\/div>\n<div class=\"badge\"><strong>Entrada al mercado<\/strong>Dise\u00f1ado para fabricantes internacionales<\/div>\n<\/div>\n<\/section>\n<section class=\"section\">\n<div class=\"grid\">\n<article class=\"card\"><span class=\"num\">01<\/span><\/p>\n<h3>Registro de productos sanitarios para diagn\u00f3stico in vitro en Per\u00fa: Evaluaci\u00f3n regulatoria<\/h3>\n<p>Evaluaci\u00f3n del dispositivo de diagn\u00f3stico in vitro (DIV), su uso previsto, las caracter\u00edsticas del producto y la v\u00eda regulatoria aplicable para su registro en Per\u00fa.<\/p>\n<\/article>\n<article class=\"card\"><span class=\"num\">02<\/span><\/p>\n<h3>Revisi\u00f3n de la documentaci\u00f3n<\/h3>\n<p>Revisi\u00f3n de la documentaci\u00f3n t\u00e9cnica y administrativa para identificar deficiencias antes de su presentaci\u00f3n.<\/p>\n<\/article>\n<article class=\"card\"><span class=\"num\">03<\/span><\/p>\n<h3>Preparaci\u00f3n del expediente<\/h3>\n<p>Organizaci\u00f3n y preparaci\u00f3n de la documentaci\u00f3n necesaria para el procedimiento DIGEMID aplicable.<\/p>\n<\/article>\n<\/div>\n<\/section>\n<section class=\"section split\">\n<div class=\"visual\" style=\"background:linear-gradient(0deg,rgba(9,47,102,.72),rgba(9,47,102,.08)),url('https:\/\/izzomed.com\/wp-content\/uploads\/2026\/09\/IVD-Automated-Laboratory.jpg') center\/cover no-repeat;\"><strong style=\"color:#fff\">Soporte regulatorio integral para productos de diagn\u00f3stico in vitro<\/strong><span style=\"color:#fff\">Estrategia de registro, preparaci\u00f3n del expediente y seguimiento regulatorio local.<\/span><\/div>\n<div>\n<div class=\"eyebrow\">Nuestro servicio<\/div>\n<h2>Registro de productos de diagn\u00f3stico in vitro y consultor\u00eda regulatoria en Per\u00fa<\/h2>\n<p>IzzoMed ofrece consultor\u00eda regulatoria para dispositivos m\u00e9dicos de diagn\u00f3stico in vitro (IVD) y apoya a los fabricantes de estos dispositivos durante todo el proceso de registro regulatorio en Per\u00fa. Evaluamos el producto, su uso previsto, la documentaci\u00f3n t\u00e9cnica disponible y los requisitos regulatorios aplicables antes de elaborar la estrategia de registro.<\/p>\n<p>Nuestro servicio est\u00e1 dise\u00f1ado para fabricantes internacionales que requieren apoyo regulatorio local para introducir productos de diagn\u00f3stico in vitro en el mercado peruano.<\/p>\n<p>Para el registro de productos de diagn\u00f3stico in vitro (IVD) en Per\u00fa, una estrategia regulatoria bien preparada puede reducir las deficiencias evitables en la documentaci\u00f3n durante la evaluaci\u00f3n. IzzoMed revisa el expediente disponible antes de su presentaci\u00f3n, coordina la documentaci\u00f3n local requerida y brinda apoyo en las respuestas a las observaciones regulatorias cuando corresponda.<\/p>\n<\/div>\n<\/section>\n<section class=\"section\">\n<div class=\"panel\">\n<div class=\"eyebrow\">Asuntos regulatorios de IVD<\/div>\n<h2>Asuntos regulatorios y requisitos para productos de diagn\u00f3stico in vitro en Per\u00fa<\/h2>\n<p>Los requisitos de registro de los dispositivos de diagn\u00f3stico in vitro (DIV) dependen de las caracter\u00edsticas y el uso previsto del producto. La documentaci\u00f3n puede incluir informaci\u00f3n del fabricante y del producto, documentaci\u00f3n de calidad, etiquetado e instrucciones de uso, informaci\u00f3n sobre el rendimiento y otras pruebas t\u00e9cnicas aplicables al DIV espec\u00edfico.<\/p>\n<p>Dado que los requisitos pueden variar seg\u00fan el producto, IzzoMed realiza una evaluaci\u00f3n regulatoria inicial antes de la presentaci\u00f3n de la solicitud para determinar la documentaci\u00f3n y la estrategia de registro adecuadas.<\/p>\n<\/div>\n<\/section>\n<section class=\"section\">\n<div class=\"eyebrow\">Nuestro proceso<\/div>\n<h2>Desde la evaluaci\u00f3n hasta la entrada en el mercado<\/h2>\n<div class=\"steps\">\n<div class=\"step\"><span class=\"num\">1<\/span><strong>Evaluar<\/strong><\/p>\n<p>Revise el producto, el fabricante, el uso previsto y la documentaci\u00f3n.<\/p>\n<\/div>\n<div class=\"step\"><span class=\"num\">2<\/span><strong>Identificar<\/strong><\/p>\n<p>Determinar los requisitos y las deficiencias en la documentaci\u00f3n.<\/p>\n<\/div>\n<div class=\"step\"><span class=\"num\">3<\/span><strong>Plan<\/strong><\/p>\n<p>Definir la estrategia de registro y los requisitos del expediente.<\/p>\n<\/div>\n<div class=\"step\"><span class=\"num\">4<\/span><strong>Entregar<\/strong><\/p>\n<p>Preparar y gestionar la presentaci\u00f3n correspondiente en DIGEMID.<\/p>\n<\/div>\n<div class=\"step\"><span class=\"num\">5<\/span><strong>Hacer un seguimiento<\/strong><\/p>\n<p>Supervisar el procedimiento y los requisitos reglamentarios.<\/p>\n<\/div>\n<\/div>\n<\/section>\n<section class=\"section\">\n<div class=\"dark\">\n<div class=\"eyebrow\">Alcance del producto<\/div>\n<h2>Tipos de productos de diagn\u00f3stico in vitro que podemos evaluar<\/h2>\n<div class=\"grid\">\n<article class=\"card\">\n<h3>Pruebas de diagn\u00f3stico r\u00e1pido<\/h3>\n<p>Pruebas r\u00e1pidas para enfermedades infecciosas, biomarcadores y otras aplicaciones de diagn\u00f3stico.<\/p>\n<\/article>\n<article class=\"card\">\n<h3>Pruebas inmunol\u00f3gicas<\/h3>\n<p>Productos de diagn\u00f3stico in vitro basados en m\u00e9todos de diagn\u00f3stico inmunol\u00f3gicos y serol\u00f3gicos.<\/p>\n<\/article>\n<article class=\"card\">\n<h3>Qu\u00edmica Cl\u00ednica y Hematolog\u00eda<\/h3>\n<p>Reactivos y productos de diagn\u00f3stico utilizados en aplicaciones de qu\u00edmica cl\u00ednica y hematolog\u00eda.<\/p>\n<\/article>\n<\/div>\n<\/div>\n<\/section>\n<section class=\"section\">\n<div class=\"panel\">\n<h2>Registro de productos de diagn\u00f3stico in vitro (IVD) con DIGEMID Per\u00fa<\/h2>\n<p>DIGEMID es la autoridad sanitaria peruana responsable de la regulaci\u00f3n sanitaria de dispositivos m\u00e9dicos y productos de diagn\u00f3stico in vitro. Antes de presentar una solicitud, los fabricantes deben confirmar la v\u00eda regulatoria aplicable y asegurarse de que el expediente t\u00e9cnico cumpla con los requisitos locales.<\/p>\n<p>Los fabricantes tambi\u00e9n pueden revisar nuestra <a href=\"https:\/\/izzomed.com\/es\/registro-de-dispositivos-medicos-en-peru\/\">Registro de dispositivos m\u00e9dicos en Per\u00fa<\/a>, <a href=\"https:\/\/izzomed.com\/es\/titular-del-registro-en-peru\/\">Titular del registro en Per\u00fa<\/a> y <a href=\"https:\/\/izzomed.com\/es\/asuntos-regulatorios-en-peru\/\">Asuntos regulatorios en Per\u00fa<\/a> servicios.<\/p>\n<\/div>\n<\/section>\n<section class=\"cta\">\n<h2>\u00bfPlanea registrar un producto de diagn\u00f3stico in vitro (DIV) en Per\u00fa?<\/h2>\n<p>Env\u00edenos la informaci\u00f3n de su producto y la documentaci\u00f3n disponible para una evaluaci\u00f3n regulatoria inicial.<\/p>\n<p><a class=\"btn\" href=\"https:\/\/izzomed.com\/es\/contacto\/\">SOLICITAR UNA EVALUACI\u00d3N REGULATORIA DE DISCO GRADUADO IN VITRO<\/a><\/section>\n<\/div>","protected":false},"excerpt":{"rendered":"<p>In Vitro Diagnostic Regulatory Services IVD Registration in Peru IVD regulatory consulting in Peru for international manufacturers seeking to register in vitro diagnostic medical devices with DIGEMID and enter the Peruvian healthcare market. CONTACT OUR TEAM \u2192 DIGEMID ExpertiseLocal regulatory support in Peru End-to-End SupportFrom assessment to regulatory follow-up Market EntryBuilt for international manufacturers 01 [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":1509,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_gspb_post_css":"#gspb_row-id-gsbp-1a4dbae,#gspb_row-id-gsbp-26beb9e{justify-content:space-between;margin-top:0;margin-bottom:0;display:flex;flex-wrap:wrap}#gspb_row-id-gsbp-26beb9e>.gspb_row__content{display:flex;justify-content:space-between;margin:0 auto;width:100%;flex-wrap:wrap}.gspb_row{position:relative}div[id^=gspb_col-id]{box-sizing:border-box;position:relative;padding:var(--gs-row-column-padding, 15px min(3vw, 20px))}#gspb_col-id-gsbp-a1d2e51.gspb_row__col--4{width:33.333333333333336%}@media 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