{"id":798,"date":"2026-08-22T17:44:50","date_gmt":"2026-08-22T17:44:50","guid":{"rendered":"https:\/\/izzomed.com\/?page_id=798"},"modified":"2026-08-28T02:31:20","modified_gmt":"2026-08-28T02:31:20","slug":"registro-de-dispositivos-medicos-en-peru","status":"publish","type":"page","link":"https:\/\/izzomed.com\/en\/registro-de-dispositivos-medicos-en-peru\/","title":{"rendered":"Registration of medical devices in Peru"},"content":{"rendered":"<div class=\"izz-device\">\n<style>.izz-device{font-family:inherit;color:#17365f;overflow:hidden}.izz-device *{box-sizing:border-box}.izz-device .dv-hero{max-width:1200px;margin:0 auto 64px;position:relative;overflow:hidden;border-radius:0 0 34px 34px;background:#f3f7fc}.izz-device .dv-hero img{display:block;width:100%;height:420px;object-fit:cover}.izz-device .dv-overlay{position:absolute;inset:0;display:flex;align-items:flex-end;padding:55px 70px;background:linear-gradient(180deg,rgba(18,59,120,0) 25%,rgba(18,59,120,.84) 100%)}.izz-device 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.dv-btn:hover{opacity:.92}@media(max-width:900px){.izz-device .dv-hero img{height:360px}.izz-device .dv-overlay{padding:40px}.izz-device .dv-title{font-size:38px}.izz-device .dv-grid{grid-template-columns:1fr 1fr}.izz-device .dv-steps{grid-template-columns:1fr 1fr}.izz-device .dv-panel,.izz-device .dv-cta{padding:40px}}@media(max-width:600px){.izz-device .dv-hero{border-radius:0 0 24px 24px;margin-bottom:48px}.izz-device .dv-hero img{height:300px}.izz-device .dv-overlay{padding:25px;background:linear-gradient(180deg,rgba(18,59,120,0) 8%,rgba(18,59,120,.9) 100%)}.izz-device .dv-title{font-size:30px}.izz-device .dv-lead{font-size:16px;padding:0 20px;margin-bottom:55px}.izz-device .dv-section,.izz-device .dv-faq{padding:0 18px;margin-bottom:58px}.izz-device .dv-heading,.izz-device .dv-faq h2{font-size:28px}.izz-device .dv-grid,.izz-device .dv-list,.izz-device .dv-steps{grid-template-columns:1fr}.izz-device .dv-card{min-height:0}.izz-device .dv-panel,.izz-device .dv-cta{padding:32px 24px;border-radius:22px}.izz-device .dv-panel h2,.izz-device .dv-cta h2{font-size:27px}}<\/style>\n<section class=\"dv-hero\"><img decoding=\"async\" src=\"https:\/\/izzomed.com\/wp-content\/uploads\/2026\/08\/registro-de-dispostivos-medicos-en-peru.png\" alt=\"registro-de-dispostivo-medicos-en-peru\"><\/p>\n<div class=\"dv-overlay\">\n<h1 class=\"dv-title\">Registration of medical devices in Peru<\/h1>\n<\/div>\n<\/section>\n<div class=\"dv-lead\"><strong>Registration of medical devices in Peru<\/strong> It requires compliance with the health and regulatory requirements applicable to each product.<\/p>\n<p>In <strong>IzzoMed<\/strong> We provide regulatory affairs services for companies and manufacturers seeking <strong>register medical devices in Peru<\/strong>, from the initial product evaluation and documentation to the management of the corresponding procedure before <a href=\"https:\/\/www.digemid.minsa.gob.pe\/webDigemid\/dispositivos-medicos-y-productos-sanitarios\/?utm_source=chatgpt.com\" target=\"_blank\" rel=\"noopener\">DIGEMID<\/a>.<\/p>\n<p>Our service <strong>registration of medical devices in Peru<\/strong> It includes the evaluation of applicable requirements, document review, and management of the corresponding procedure.<\/p>\n<p>We work with <strong>national and international manufacturers<\/strong> who are looking to introduce their medical devices into the Peruvian market.<\/div>\n<section class=\"dv-section\">\n<h2 class=\"dv-heading\">Services for the registration of medical devices in Peru<\/h2>\n<p class=\"dv-intro\">We support each project according to the characteristics of the device, its documentation and the needs of the manufacturer or company responsible for its entry into the Peruvian market.<\/p>\n<div class=\"dv-grid\">\n<article class=\"dv-card\">\n<h3>Regulatory assessment<\/h3>\n<p>We analyze the characteristics of the medical device and the available documentation to identify applicable regulatory requirements and determine the appropriate path for its registration.<\/p>\n<\/article>\n<article class=\"dv-card\">\n<h3>Documentation review<\/h3>\n<p>We review the available technical and administrative documentation to identify any gaps, inconsistencies, or documents that need to be supplemented before starting the procedure.<\/p>\n<\/article>\n<article class=\"dv-card\">\n<h3>Regulatory strategy<\/h3>\n<p>We define a strategy according to the product characteristics and applicable requirements, seeking to avoid unnecessary steps and facilitate the development of the regulatory procedure.<\/p>\n<\/article>\n<article class=\"dv-card\">\n<h3>Preparation and management of the file<\/h3>\n<p>We support the preparation of the necessary documentation and the management of the corresponding file before the health authority.<\/p>\n<\/article>\n<article class=\"dv-card\">\n<h3>Local representation<\/h3>\n<p>We provide regulatory representation and support in Peru for international manufacturers who require a local partner to manage their regulatory activities.<\/p>\n<\/article>\n<article class=\"dv-card\">\n<h3>Procedure monitoring<\/h3>\n<p>We support the regulatory process and monitor the actions and requirements related to the corresponding procedure.<\/p>\n<\/article>\n<\/div>\n<\/section>\n<section class=\"dv-section\">\n<div class=\"dv-panel\">\n<h2>What medical devices can we manage?<\/h2>\n<p>We work with different types of medical devices subject to health regulations in Peru.<\/p>\n<p>Among the projects we can evaluate are:<\/p>\n<div class=\"dv-list\">\n<div class=\"dv-list-item\">Medical equipment and devices.<\/div>\n<div class=\"dv-list-item\">Devices used for diagnosis and treatment.<\/div>\n<div class=\"dv-list-item\">Electromedical equipment.<\/div>\n<div class=\"dv-list-item\">Sterile medical devices.<\/div>\n<div class=\"dv-list-item\">Single-use medical devices.<\/div>\n<div class=\"dv-list-item\">Devices used in surgical procedures.<\/div>\n<div class=\"dv-list-item\">Specialized medical products and technologies.<\/div>\n<\/div>\n<p><strong>Each device requires an individual evaluation.<\/strong>, since the requirements may vary according to their characteristics, intended purpose, documentation and marketing conditions.<\/p>\n<\/div>\n<\/section>\n<section class=\"dv-section\">\n<div class=\"dv-panel\">\n<h2>Registration of medical devices with DIGEMID<\/h2>\n<p>The regulatory procedure depends on the particular characteristics of each device and the requirements established by the Peruvian health authority.<\/p>\n<p>Before starting a procedure, we recommend performing a <strong>regulatory assessment of the product<\/strong> to identify available documentation, applicable requirements, and potential gaps that need to be addressed.<\/p>\n<p>This analysis allows for the establishment of an appropriate strategy and the preparation of the project before submitting the corresponding documentation.<\/p>\n<\/div>\n<\/section>\n<section class=\"dv-section\">\n<div class=\"dv-panel\">\n<h2>Medical devices from international manufacturers<\/h2>\n<p>For a foreign manufacturer, entering the Peruvian market involves understanding local requirements and having a structure that allows for the proper management of the product in the country.<\/p>\n<p>In <strong>IzzoMed<\/strong> We work with international manufacturers who are looking to introduce their medical devices in Peru.<\/p>\n<p>We can participate from the <strong>Initial product assessment and document review<\/strong> including local representation, regulatory management and coordination of services related to its entry and marketing.<\/p>\n<p>Our goal is to facilitate the development of the project and provide the manufacturer with a local support point for their regulatory activities.<\/p>\n<\/div>\n<\/section>\n<section class=\"dv-section dv-process\">\n<h2 class=\"dv-heading\">Our process<\/h2>\n<\/p>\n<\/p>\n<\/p>\n<div class=\"dv-steps\">\n<article class=\"dv-step\" data-step=\"1\">\n<h3>We evaluate<\/h3>\n<p>We analyzed the device, its manufacturer, intended purpose, and available documentation.<\/p>\n<\/article>\n<article class=\"dv-step\" data-step=\"2\">\n<h3>We identified<\/h3>\n<p>We determine the regulatory requirements and aspects that must be addressed before starting the procedure.<\/p>\n<\/article>\n<article class=\"dv-step\" data-step=\"3\">\n<h3>We plan<\/h3>\n<p>We defined the strategy and the steps necessary to develop the project.<\/p>\n<\/article>\n<article class=\"dv-step\" data-step=\"4\">\n<h3>We manage<\/h3>\n<p>We assist in the preparation and management of the corresponding regulatory procedure.<\/p>\n<\/article>\n<article class=\"dv-step\" data-step=\"5\">\n<h3>We accompany<\/h3>\n<p>We provide support during the process and, where appropriate, after registration is obtained.<\/p>\n<\/article>\n<\/div>\n<\/section>\n<section class=\"dv-section\">\n<div class=\"dv-panel\">\n<h2>More than a health registration<\/h2>\n<p>The entry of a medical device into the Peruvian market does not end with the management of the regulatory procedure.<\/p>\n<p>Depending on the project&#039;s needs, we can complement the regulatory service with solutions related to <strong>import, storage, distribution and marketing<\/strong>.<\/p>\n<p>This allows manufacturers and companies to comprehensively assess the needs of their project before entering the Peruvian market.<\/p>\n<\/div>\n<\/section>\n<section class=\"dv-faq\">\n<h2>Frequently asked questions about medical devices in Peru<\/h2>\n<div class=\"gs-accordion gs-accordion-id-gsbp-device\">\n<div class=\"gs-accordion-item gsopen\">\n<div class=\"gs-accordion-item__title\" role=\"button\" tabindex=\"0\">\n<div class=\"gs-accordion-item__heading\">What is a medical device?<\/div>\n<p><span class=\"iconfortoggle\"><span class=\"gs-iconbefore\"><\/span><span class=\"gs-iconafter\"><\/span><\/span><\/div>\n<div class=\"gs-accordion-item__content\">\n<div class=\"gs-accordion-item__text\">A medical device is a product intended to be used for medical purposes, such as diagnosis, prevention, monitoring, treatment or relief of diseases or injuries, according to its intended purpose.<\/div>\n<\/div>\n<\/div>\n<div class=\"gs-accordion-item gsopen\">\n<div class=\"gs-accordion-item__title\" role=\"button\" tabindex=\"0\">\n<div class=\"gs-accordion-item__heading\">Do all medical devices require health registration in Peru?<\/div>\n<p><span class=\"iconfortoggle\"><span class=\"gs-iconbefore\"><\/span><span class=\"gs-iconafter\"><\/span><\/span><\/div>\n<div class=\"gs-accordion-item__content\">\n<div class=\"gs-accordion-item__text\">Regulatory requirements depend on the product&#039;s characteristics and classification, as well as applicable health regulations. Therefore, we recommend conducting a preliminary assessment before initiating the procedure.<\/div>\n<\/div>\n<\/div>\n<div class=\"gs-accordion-item gsopen\">\n<div class=\"gs-accordion-item__title\" role=\"button\" tabindex=\"0\">\n<div class=\"gs-accordion-item__heading\">Can you help me register a medical device with DIGEMID?<\/div>\n<p><span class=\"iconfortoggle\"><span class=\"gs-iconbefore\"><\/span><span class=\"gs-iconafter\"><\/span><\/span><\/div>\n<div class=\"gs-accordion-item__content\">\n<div class=\"gs-accordion-item__text\">Yes. IzzoMed provides management and regulatory support services for medical device-related projects, including assessment, document review, preparation and management of the corresponding procedure.<\/div>\n<\/div>\n<\/div>\n<div class=\"gs-accordion-item gsopen\">\n<div class=\"gs-accordion-item__title\" role=\"button\" tabindex=\"0\">\n<div class=\"gs-accordion-item__heading\">Do you work with foreign manufacturers?<\/div>\n<p><span class=\"iconfortoggle\"><span class=\"gs-iconbefore\"><\/span><span class=\"gs-iconafter\"><\/span><\/span><\/div>\n<div class=\"gs-accordion-item__content\">\n<div class=\"gs-accordion-item__text\">Yes. We work with international manufacturers seeking to introduce their medical devices to the Peruvian market and who require regulatory support and local representation.<\/div>\n<\/div>\n<\/div>\n<div class=\"gs-accordion-item gsopen\">\n<div class=\"gs-accordion-item__title\" role=\"button\" tabindex=\"0\">\n<div class=\"gs-accordion-item__heading\">Can you evaluate my device before starting the registration?<\/div>\n<p><span class=\"iconfortoggle\"><span class=\"gs-iconbefore\"><\/span><span class=\"gs-iconafter\"><\/span><\/span><\/div>\n<div class=\"gs-accordion-item__content\">\n<div class=\"gs-accordion-item__text\">Yes. An initial regulatory assessment allows for a review of the product&#039;s characteristics and available documentation to identify applicable requirements before initiating the procedure.<\/div>\n<\/div>\n<\/div>\n<div class=\"gs-accordion-item gsopen\">\n<div class=\"gs-accordion-item__title\" role=\"button\" tabindex=\"0\">\n<div class=\"gs-accordion-item__heading\">Can they also help with importing and distribution?<\/div>\n<p><span class=\"iconfortoggle\"><span class=\"gs-iconbefore\"><\/span><span class=\"gs-iconafter\"><\/span><\/span><\/div>\n<div class=\"gs-accordion-item__content\">\n<div class=\"gs-accordion-item__text\">Yes. Depending on the project&#039;s needs, regulatory services can be complemented with solutions related to import, storage, and distribution.<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/section>\n<section class=\"dv-cta\">\n<h2>Do you want to register your medical device in Peru?<\/h2>\n<p>If you are evaluating the <strong>registration of medical devices in Peru<\/strong>, We can review the product features and available documentation beforehand.<\/p>\n<p><a class=\"dv-btn\" href=\"https:\/\/izzomed.com\/en\/contactanos\/\">REQUEST REGULATORY ASSESSMENT<\/a><\/section>\n<\/div>","protected":false},"excerpt":{"rendered":"<p>Registro de dispositivos m\u00e9dicos en Per\u00fa El registro de dispositivos m\u00e9dicos en Per\u00fa requiere cumplir con los requisitos sanitarios y regulatorios aplicables a cada producto. En IzzoMed brindamos servicios de asuntos regulatorios para empresas y fabricantes que buscan registrar dispositivos m\u00e9dicos en Per\u00fa, desde la evaluaci\u00f3n inicial del producto y su documentaci\u00f3n hasta la gesti\u00f3n [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":0,"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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