{"id":3014,"date":"2021-10-27T09:48:42","date_gmt":"2021-10-27T01:48:42","guid":{"rendered":"https:\/\/regask.com\/?p=3014"},"modified":"2024-10-26T03:19:36","modified_gmt":"2024-10-25T19:19:36","slug":"regulaciones-canadienses-sobre-dispositivos-medicos","status":"publish","type":"post","link":"https:\/\/regask.com\/es\/canada-medical-device-regulations\/","title":{"rendered":"Health Canada modific\u00f3 ciertas reglamentaciones relativas a m\u00ed\u2026"},"content":{"rendered":"<p>El 11 de agosto de 2021, la HSA modific\u00f3 el Reglamento sobre alimentos y medicamentos y el Reglamento sobre dispositivos m\u00e9dicos en relaci\u00f3n con la escasez de dispositivos m\u00e9dicos y medicamentos en Canad\u00e1; la modificaci\u00f3n se public\u00f3 en la Gaceta de Canad\u00e1, Parte II, el 1 de septiembre de 2021.<\/p>\n<p>Estas nuevas regulaciones ampl\u00edan y modifican ciertas medidas ya vigentes mediante dos \u00f3rdenes provisionales. Su objetivo es ayudar a rastrear, prevenir y mitigar la escasez de productos sanitarios esenciales en Canad\u00e1, como medicamentos y dispositivos m\u00e9dicos.<\/p>\n<p>Entrando en vigor el <strong>27 de noviembre de 2021<\/strong>, son disposiciones que:<\/p>\n<ul>\n<li>Prohibir la distribuci\u00f3n fuera de Canad\u00e1 de medicamentos destinados al mercado canadiense que puedan causar o agravar una escasez,<\/li>\n<li>Permitir al Ministro obligar a proporcionar informaci\u00f3n respecto de la escasez de medicamentos.<\/li>\n<\/ul>\n<p>Entrando en vigor el <strong>1 de marzo de 2022<\/strong>, son disposiciones relativas a:<\/p>\n<ul>\n<li>Importaci\u00f3n y venta excepcional de medicamentos, dispositivos m\u00e9dicos,<\/li>\n<li>Notificaci\u00f3n obligatoria de escasez de dispositivos m\u00e9dicos espec\u00edficos y facultad para exigir informaci\u00f3n sobre escasez de dispositivos m\u00e9dicos,<\/li>\n<li>Ampliaci\u00f3n de las flexibilidades de licencia para algunos desinfectantes de manos a base de medicamentos.<\/li>\n<\/ul>\n<p>Comun\u00edquese con RegASK para obtener m\u00e1s informaci\u00f3n sobre los cambios en la regulaci\u00f3n de dispositivos m\u00e9dicos. <a href=\"https:\/\/regask.com\/es\/contacto\/\" target=\"_blank\" rel=\"noopener\">Ponte en contacto con los expertos de RegASK.<\/a><\/p>\n<p>&nbsp;<\/p>\n<a href=\"https:\/\/regask.com\/es\/contacto\/\" class=\"button secondary\" style=\"border-radius:10px;\">\n\t\t<span>Contacte con RegASK para m\u00e1s detalles<\/span>\n\t<\/a>\n\n<a href=\"https:\/\/www.gazette.gc.ca\/rp-pr\/p2\/2021\/2021-09-01\/html\/sor-dors199-eng.html\" target=\"_blank\" class=\"button secondary is-link\" rel=\"noopener\" >\n\t\t<span>Leer m\u00e1s<\/span>\n\t<\/a>\n\n<div class=\"row\"  id=\"row-1197328501\">\n\n\t<div id=\"col-757686916\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n<a href=\"https:\/\/regask.com\/es\/estudios-de-caso\/recursos-casos-de-estudio-dispositivos-medicos\/\" target=\"_blank\" class=\"button secondary is-link\" rel=\"noopener\" >\n\t\t<span>Lea estudios de casos de la industria de dispositivos m\u00e9dicos<\/span>\n\t<\/a>\n\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\n\t\n<\/div>","protected":false},"excerpt":{"rendered":"<p>El 11 de agosto de 2021, la HSA modific\u00f3 el Reglamento sobre Alimentos y Medicamentos y el Reglamento sobre Dispositivos M\u00e9dicos en relaci\u00f3n con la escasez de dispositivos m\u00e9dicos y medicamentos medicinales en Canad\u00e1. La modificaci\u00f3n se public\u00f3 en la Gaceta de Canad\u00e1, Parte II, el 1 de septiembre de 2021. Estas nuevas regulaciones ampl\u00edan y modifican ciertas medidas ya vigentes mediante dos \u00f3rdenes provisionales (OI).<\/p>","protected":false},"author":39,"featured_media":2976,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[513,39],"tags":[40],"class_list":["post-3014","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-canada-regulations","category-medical-devices-insights","tag-latest-insights"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v28.0 (Yoast SEO v28.1) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>Canada Amends Medical Device Regs | RegASK<\/title>\n<meta name=\"description\" content=\"Health Canada amends regulations concerning medical devices. Stay updated on the latest changes with RegASK.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/regask.com\/es\/regulaciones-canadienses-sobre-dispositivos-medicos\/\" \/>\n<meta property=\"og:locale\" content=\"es_ES\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Health Canada Amended Certain Regulations Concerning Medical Devices\" \/>\n<meta property=\"og:description\" content=\"Health Canada amends regulations concerning medical devices. Stay updated on the latest changes with RegASK.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/regask.com\/es\/regulaciones-canadienses-sobre-dispositivos-medicos\/\" \/>\n<meta property=\"og:site_name\" content=\"RegASK\" \/>\n<meta property=\"article:publisher\" content=\"https:\/\/www.facebook.com\/RegASKRegulatoryAffairs\/\" \/>\n<meta property=\"article:published_time\" content=\"2021-10-27T01:48:42+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2024-10-25T19:19:36+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/regask.com\/wp-content\/uploads\/2021\/09\/Therapeutic-goods-medical-devices.png\" \/>\n\t<meta property=\"og:image:width\" content=\"689\" \/>\n\t<meta property=\"og:image:height\" content=\"626\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/png\" \/>\n<meta name=\"author\" content=\"Benoit Trouwaert\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:creator\" content=\"@ASKRegASK\" \/>\n<meta name=\"twitter:site\" content=\"@ASKRegASK\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"Benoit Trouwaert\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"2 minutos\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\\\/\\\/regask.com\\\/canada-medical-device-regulations\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/regask.com\\\/canada-medical-device-regulations\\\/\"},\"author\":{\"name\":\"Benoit Trouwaert\",\"@id\":\"https:\\\/\\\/regask.com\\\/#\\\/schema\\\/person\\\/c1d261e8dcf7b1c30b2c4f2c119df42d\"},\"headline\":\"Health Canada Amended Certain Regulations Concerning Me&hellip;\",\"datePublished\":\"2021-10-27T01:48:42+00:00\",\"dateModified\":\"2024-10-25T19:19:36+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/regask.com\\\/canada-medical-device-regulations\\\/\"},\"wordCount\":252,\"publisher\":{\"@id\":\"https:\\\/\\\/regask.com\\\/#organization\"},\"image\":{\"@id\":\"https:\\\/\\\/regask.com\\\/canada-medical-device-regulations\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/regask.com\\\/wp-content\\\/uploads\\\/2021\\\/09\\\/Therapeutic-goods-medical-devices.png\",\"keywords\":[\"Latest Insights\"],\"articleSection\":[\"Canada\",\"Medical Devices\"],\"inLanguage\":\"es\"},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/regask.com\\\/canada-medical-device-regulations\\\/\",\"url\":\"https:\\\/\\\/regask.com\\\/canada-medical-device-regulations\\\/\",\"name\":\"Canada Amends Medical Device Regs | RegASK\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/regask.com\\\/#website\"},\"primaryImageOfPage\":{\"@id\":\"https:\\\/\\\/regask.com\\\/canada-medical-device-regulations\\\/#primaryimage\"},\"image\":{\"@id\":\"https:\\\/\\\/regask.com\\\/canada-medical-device-regulations\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/regask.com\\\/wp-content\\\/uploads\\\/2021\\\/09\\\/Therapeutic-goods-medical-devices.png\",\"datePublished\":\"2021-10-27T01:48:42+00:00\",\"dateModified\":\"2024-10-25T19:19:36+00:00\",\"description\":\"Health Canada amends regulations concerning medical devices. Stay updated on the latest changes with RegASK.\",\"inLanguage\":\"es\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\\\/\\\/regask.com\\\/canada-medical-device-regulations\\\/\"]}]},{\"@type\":\"ImageObject\",\"inLanguage\":\"es\",\"@id\":\"https:\\\/\\\/regask.com\\\/canada-medical-device-regulations\\\/#primaryimage\",\"url\":\"https:\\\/\\\/regask.com\\\/wp-content\\\/uploads\\\/2021\\\/09\\\/Therapeutic-goods-medical-devices.png\",\"contentUrl\":\"https:\\\/\\\/regask.com\\\/wp-content\\\/uploads\\\/2021\\\/09\\\/Therapeutic-goods-medical-devices.png\",\"width\":689,\"height\":626,\"caption\":\"fda\"},{\"@type\":\"WebSite\",\"@id\":\"https:\\\/\\\/regask.com\\\/#website\",\"url\":\"https:\\\/\\\/regask.com\\\/\",\"name\":\"RegASK\",\"description\":\"The Regulatory AI Operating System for High-Performing Teams\",\"publisher\":{\"@id\":\"https:\\\/\\\/regask.com\\\/#organization\"},\"potentialAction\":[{\"@type\":\"SearchAction\",\"target\":{\"@type\":\"EntryPoint\",\"urlTemplate\":\"https:\\\/\\\/regask.com\\\/?s={search_term_string}\"},\"query-input\":{\"@type\":\"PropertyValueSpecification\",\"valueRequired\":true,\"valueName\":\"search_term_string\"}}],\"inLanguage\":\"es\"},{\"@type\":\"Person\",\"@id\":\"https:\\\/\\\/regask.com\\\/#\\\/schema\\\/person\\\/c1d261e8dcf7b1c30b2c4f2c119df42d\",\"name\":\"Benoit Trouwaert\"}]}<\/script>\n<!-- \/ Yoast SEO Premium plugin. -->","yoast_head_json":{"title":"Canad\u00e1 modifica el reglamento sobre dispositivos m\u00e9dicos | RegASK","description":"Health Canada modifica la normativa sobre dispositivos m\u00e9dicos. Mant\u00e9ngase al d\u00eda con los \u00faltimos cambios con RegASK.","robots":{"index":"index","follow":"follow","max-snippet":"max-snippet:-1","max-image-preview":"max-image-preview:large","max-video-preview":"max-video-preview:-1"},"canonical":"https:\/\/regask.com\/es\/regulaciones-canadienses-sobre-dispositivos-medicos\/","og_locale":"es_ES","og_type":"article","og_title":"Health Canada Amended Certain Regulations Concerning Medical Devices","og_description":"Health Canada amends regulations concerning medical devices. Stay updated on the latest changes with RegASK.","og_url":"https:\/\/regask.com\/es\/regulaciones-canadienses-sobre-dispositivos-medicos\/","og_site_name":"RegASK","article_publisher":"https:\/\/www.facebook.com\/RegASKRegulatoryAffairs\/","article_published_time":"2021-10-27T01:48:42+00:00","article_modified_time":"2024-10-25T19:19:36+00:00","og_image":[{"width":689,"height":626,"url":"https:\/\/regask.com\/wp-content\/uploads\/2021\/09\/Therapeutic-goods-medical-devices.png","type":"image\/png"}],"author":"Benoit Trouwaert","twitter_card":"summary_large_image","twitter_creator":"@ASKRegASK","twitter_site":"@ASKRegASK","twitter_misc":{"Written by":"Benoit Trouwaert","Est. reading time":"2 minutos"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"Article","@id":"https:\/\/regask.com\/canada-medical-device-regulations\/#article","isPartOf":{"@id":"https:\/\/regask.com\/canada-medical-device-regulations\/"},"author":{"name":"Benoit Trouwaert","@id":"https:\/\/regask.com\/#\/schema\/person\/c1d261e8dcf7b1c30b2c4f2c119df42d"},"headline":"Health Canada Amended Certain Regulations Concerning Me&hellip;","datePublished":"2021-10-27T01:48:42+00:00","dateModified":"2024-10-25T19:19:36+00:00","mainEntityOfPage":{"@id":"https:\/\/regask.com\/canada-medical-device-regulations\/"},"wordCount":252,"publisher":{"@id":"https:\/\/regask.com\/#organization"},"image":{"@id":"https:\/\/regask.com\/canada-medical-device-regulations\/#primaryimage"},"thumbnailUrl":"https:\/\/regask.com\/wp-content\/uploads\/2021\/09\/Therapeutic-goods-medical-devices.png","keywords":["Latest Insights"],"articleSection":["Canada","Medical Devices"],"inLanguage":"es"},{"@type":"WebPage","@id":"https:\/\/regask.com\/canada-medical-device-regulations\/","url":"https:\/\/regask.com\/canada-medical-device-regulations\/","name":"Canad\u00e1 modifica el reglamento sobre dispositivos m\u00e9dicos | RegASK","isPartOf":{"@id":"https:\/\/regask.com\/#website"},"primaryImageOfPage":{"@id":"https:\/\/regask.com\/canada-medical-device-regulations\/#primaryimage"},"image":{"@id":"https:\/\/regask.com\/canada-medical-device-regulations\/#primaryimage"},"thumbnailUrl":"https:\/\/regask.com\/wp-content\/uploads\/2021\/09\/Therapeutic-goods-medical-devices.png","datePublished":"2021-10-27T01:48:42+00:00","dateModified":"2024-10-25T19:19:36+00:00","description":"Health Canada modifica la normativa sobre dispositivos m\u00e9dicos. Mant\u00e9ngase al d\u00eda con los \u00faltimos cambios con RegASK.","inLanguage":"es","potentialAction":[{"@type":"ReadAction","target":["https:\/\/regask.com\/canada-medical-device-regulations\/"]}]},{"@type":"ImageObject","inLanguage":"es","@id":"https:\/\/regask.com\/canada-medical-device-regulations\/#primaryimage","url":"https:\/\/regask.com\/wp-content\/uploads\/2021\/09\/Therapeutic-goods-medical-devices.png","contentUrl":"https:\/\/regask.com\/wp-content\/uploads\/2021\/09\/Therapeutic-goods-medical-devices.png","width":689,"height":626,"caption":"fda"},{"@type":"WebSite","@id":"https:\/\/regask.com\/#website","url":"https:\/\/regask.com\/","name":"RegASK","description":"El sistema operativo de IA regulatoria para equipos de alto rendimiento","publisher":{"@id":"https:\/\/regask.com\/#organization"},"potentialAction":[{"@type":"SearchAction","target":{"@type":"EntryPoint","urlTemplate":"https:\/\/regask.com\/?s={search_term_string}"},"query-input":{"@type":"PropertyValueSpecification","valueRequired":true,"valueName":"search_term_string"}}],"inLanguage":"es"},{"@type":"Person","@id":"https:\/\/regask.com\/#\/schema\/person\/c1d261e8dcf7b1c30b2c4f2c119df42d","name":"Benoit Trouwaert"}]}},"_links":{"self":[{"href":"https:\/\/regask.com\/es\/wp-json\/wp\/v2\/posts\/3014","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/regask.com\/es\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/regask.com\/es\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/regask.com\/es\/wp-json\/wp\/v2\/users\/39"}],"replies":[{"embeddable":true,"href":"https:\/\/regask.com\/es\/wp-json\/wp\/v2\/comments?post=3014"}],"version-history":[{"count":0,"href":"https:\/\/regask.com\/es\/wp-json\/wp\/v2\/posts\/3014\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/regask.com\/es\/wp-json\/wp\/v2\/media\/2976"}],"wp:attachment":[{"href":"https:\/\/regask.com\/es\/wp-json\/wp\/v2\/media?parent=3014"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/regask.com\/es\/wp-json\/wp\/v2\/categories?post=3014"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/regask.com\/es\/wp-json\/wp\/v2\/tags?post=3014"}],"curies":[{"name":"Gracias","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}