{"id":3015,"date":"2021-10-27T09:53:24","date_gmt":"2021-10-27T01:53:24","guid":{"rendered":"https:\/\/regask.com\/?p=3015"},"modified":"2024-09-25T04:02:14","modified_gmt":"2024-09-24T20:02:14","slug":"registro-de-dispositivo-medico-covid-19","status":"publish","type":"post","link":"https:\/\/regask.com\/es\/covid-19-medical-device-registration\/","title":{"rendered":"Nueva Circular sobre Expedici\u00f3n de N\u00famero de Registro de Medi\u2026"},"content":{"rendered":"

La Circular No. 13\/2021\/TT-BYT del 16 de septiembre de 2021 prescribe los expedientes y procedimientos para la emisi\u00f3n de n\u00fameros de registro de venta libre para dispositivos m\u00e9dicos, suministros m\u00e9dicos, productos biol\u00f3gicos y productos qu\u00edmicos utilizados en la prevenci\u00f3n y el control de COVID-19, incluidos:<\/p>\n

M\u00e1quina de extracci\u00f3n; m\u00e1quina de PCR; productos qu\u00edmicos (productos biol\u00f3gicos) que hacen funcionar una m\u00e1quina de PCR para detectar el SARS-CoV-2; kit de prueba r\u00e1pida para ant\u00edgeno\/anticuerpo contra el SARS-CoV-2; ventiladores de alta funci\u00f3n, ventiladores invasivos y no invasivos, ventiladores no invasivos, m\u00e1quinas de ox\u00edgeno de alto flujo, ventiladores port\u00e1tiles; m\u00e1quina de di\u00e1lisis continua; m\u00e1quina de rayos X port\u00e1til; m\u00e1quina de ultrasonido Doppler color \u2265 3 sondas; medidor de gases en sangre (mide electrolitos, lactato, hematocrito); monitor de paciente \u2265 5 par\u00e1metros; bomba de inyecci\u00f3n el\u00e9ctrica; m\u00e1quina de infusi\u00f3n; desfibriladores marcapasos; m\u00e1quina de ECG \u2265 6 canales; m\u00e1quina de ultrasonido port\u00e1til; medidor de tiempo de coagulaci\u00f3n; medidor hemodin\u00e1mico.<\/p>\n

Periodo de vigencia: 16\/09\/2021 \u2013 31\/12\/2022<\/strong><\/p>\n

Comun\u00edquese con RegASK para obtener m\u00e1s informaci\u00f3n sobre los cambios en la regulaci\u00f3n de dispositivos m\u00e9dicos. Ponte en contacto con los expertos de RegASK.<\/a><\/p>\n

 <\/p>\n\n\t\tContacte con RegASK para m\u00e1s detalles<\/span>\n\t<\/a>\n\n\n\t\tLeer m\u00e1s<\/span>\n\t<\/a>\n\n

\n\n\t
\n\t\t\t\t
\n\t\t\t\n\t\t\t\n\n\t\tLea 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":"

Circular No. 13\/2021\/TT-BYT dated September 16, 2021 prescribes dossiers and procedures for issuance of free-sale registration numbers for medical devices, medical supplies, biological products, and chemicals used in COVID-19 prevention and control, including: Extraction machine; PCR machine; chemicals (biological products) running a PCR machine to test for SARS-CoV-2; rapid test kit for antigen\/antibody against SARS-CoV-2;…<\/p>","protected":false},"author":39,"featured_media":2484,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[39],"tags":[40],"class_list":["post-3015","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-medical-devices-insights","tag-latest-insights"],"acf":[],"yoast_head":"\nNew Circular on COVID-19 Medical Device Registration | RegASK<\/title>\n<meta name=\"description\" content=\"A new circular has been issued regarding the registration of medical devices for COVID-19 management. Learn more 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\/registro-de-dispositivo-medico-covid-19\/\" \/>\n<meta property=\"og:locale\" content=\"es_ES\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"New Circular on Issuance of Registration Number of Medical Devices Serving COVID-19 Epidemic Management\" \/>\n<meta property=\"og:description\" content=\"A new circular has been issued regarding the registration of medical devices for COVID-19 management. Learn more with RegASK.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/regask.com\/es\/registro-de-dispositivo-medico-covid-19\/\" \/>\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=\"2021-10-27T01:53:24+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2024-09-24T20:02:14+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/regask.com\/wp-content\/uploads\/2021\/04\/healthcare-medical-device.png\" \/>\n\t<meta property=\"og:image:width\" content=\"688\" \/>\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=\"1 minuto\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\\\/\\\/regask.com\\\/covid-19-medical-device-registration\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/regask.com\\\/covid-19-medical-device-registration\\\/\"},\"author\":{\"name\":\"Benoit Trouwaert\",\"@id\":\"https:\\\/\\\/regask.com\\\/#\\\/schema\\\/person\\\/c1d261e8dcf7b1c30b2c4f2c119df42d\"},\"headline\":\"New Circular on Issuance of Registration Number of Medi…\",\"datePublished\":\"2021-10-27T01:53:24+00:00\",\"dateModified\":\"2024-09-24T20:02:14+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/regask.com\\\/covid-19-medical-device-registration\\\/\"},\"wordCount\":209,\"publisher\":{\"@id\":\"https:\\\/\\\/regask.com\\\/#organization\"},\"image\":{\"@id\":\"https:\\\/\\\/regask.com\\\/covid-19-medical-device-registration\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/regask.com\\\/wp-content\\\/uploads\\\/2021\\\/04\\\/healthcare-medical-device.png\",\"keywords\":[\"Latest Insights\"],\"articleSection\":[\"Medical Devices\"],\"inLanguage\":\"es\"},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/regask.com\\\/covid-19-medical-device-registration\\\/\",\"url\":\"https:\\\/\\\/regask.com\\\/covid-19-medical-device-registration\\\/\",\"name\":\"New Circular on COVID-19 Medical Device Registration | RegASK\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/regask.com\\\/#website\"},\"primaryImageOfPage\":{\"@id\":\"https:\\\/\\\/regask.com\\\/covid-19-medical-device-registration\\\/#primaryimage\"},\"image\":{\"@id\":\"https:\\\/\\\/regask.com\\\/covid-19-medical-device-registration\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/regask.com\\\/wp-content\\\/uploads\\\/2021\\\/04\\\/healthcare-medical-device.png\",\"datePublished\":\"2021-10-27T01:53:24+00:00\",\"dateModified\":\"2024-09-24T20:02:14+00:00\",\"description\":\"A new circular has been issued regarding the registration of medical devices for COVID-19 management. Learn more with RegASK.\",\"inLanguage\":\"es\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\\\/\\\/regask.com\\\/covid-19-medical-device-registration\\\/\"]}]},{\"@type\":\"ImageObject\",\"inLanguage\":\"es\",\"@id\":\"https:\\\/\\\/regask.com\\\/covid-19-medical-device-registration\\\/#primaryimage\",\"url\":\"https:\\\/\\\/regask.com\\\/wp-content\\\/uploads\\\/2021\\\/04\\\/healthcare-medical-device.png\",\"contentUrl\":\"https:\\\/\\\/regask.com\\\/wp-content\\\/uploads\\\/2021\\\/04\\\/healthcare-medical-device.png\",\"width\":688,\"height\":626,\"caption\":\"Healthcare Medical Tester\"},{\"@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":"Nueva Circular sobre Registro de Dispositivos M\u00e9dicos COVID-19 | RegASK","description":"Se ha emitido una nueva circular sobre el registro de dispositivos m\u00e9dicos para el tratamiento de la COVID-19. Obtenga m\u00e1s informaci\u00f3n 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\/registro-de-dispositivo-medico-covid-19\/","og_locale":"es_ES","og_type":"article","og_title":"New Circular on Issuance of Registration Number of Medical Devices Serving COVID-19 Epidemic Management","og_description":"A new circular has been issued regarding the registration of medical devices for COVID-19 management. Learn more with RegASK.","og_url":"https:\/\/regask.com\/es\/registro-de-dispositivo-medico-covid-19\/","og_site_name":"RegASK","article_publisher":"https:\/\/www.facebook.com\/RegASKRegulatoryAffairs\/","article_published_time":"2021-10-27T01:53:24+00:00","article_modified_time":"2024-09-24T20:02:14+00:00","og_image":[{"width":688,"height":626,"url":"https:\/\/regask.com\/wp-content\/uploads\/2021\/04\/healthcare-medical-device.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":"1 minuto"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"Article","@id":"https:\/\/regask.com\/covid-19-medical-device-registration\/#article","isPartOf":{"@id":"https:\/\/regask.com\/covid-19-medical-device-registration\/"},"author":{"name":"Benoit Trouwaert","@id":"https:\/\/regask.com\/#\/schema\/person\/c1d261e8dcf7b1c30b2c4f2c119df42d"},"headline":"New Circular on Issuance of Registration Number of Medi…","datePublished":"2021-10-27T01:53:24+00:00","dateModified":"2024-09-24T20:02:14+00:00","mainEntityOfPage":{"@id":"https:\/\/regask.com\/covid-19-medical-device-registration\/"},"wordCount":209,"publisher":{"@id":"https:\/\/regask.com\/#organization"},"image":{"@id":"https:\/\/regask.com\/covid-19-medical-device-registration\/#primaryimage"},"thumbnailUrl":"https:\/\/regask.com\/wp-content\/uploads\/2021\/04\/healthcare-medical-device.png","keywords":["Latest Insights"],"articleSection":["Medical Devices"],"inLanguage":"es"},{"@type":"WebPage","@id":"https:\/\/regask.com\/covid-19-medical-device-registration\/","url":"https:\/\/regask.com\/covid-19-medical-device-registration\/","name":"Nueva Circular sobre Registro de Dispositivos M\u00e9dicos COVID-19 | RegASK","isPartOf":{"@id":"https:\/\/regask.com\/#website"},"primaryImageOfPage":{"@id":"https:\/\/regask.com\/covid-19-medical-device-registration\/#primaryimage"},"image":{"@id":"https:\/\/regask.com\/covid-19-medical-device-registration\/#primaryimage"},"thumbnailUrl":"https:\/\/regask.com\/wp-content\/uploads\/2021\/04\/healthcare-medical-device.png","datePublished":"2021-10-27T01:53:24+00:00","dateModified":"2024-09-24T20:02:14+00:00","description":"Se ha emitido una nueva circular sobre el registro de dispositivos m\u00e9dicos para el tratamiento de la COVID-19. Obtenga m\u00e1s informaci\u00f3n con RegASK.","inLanguage":"es","potentialAction":[{"@type":"ReadAction","target":["https:\/\/regask.com\/covid-19-medical-device-registration\/"]}]},{"@type":"ImageObject","inLanguage":"es","@id":"https:\/\/regask.com\/covid-19-medical-device-registration\/#primaryimage","url":"https:\/\/regask.com\/wp-content\/uploads\/2021\/04\/healthcare-medical-device.png","contentUrl":"https:\/\/regask.com\/wp-content\/uploads\/2021\/04\/healthcare-medical-device.png","width":688,"height":626,"caption":"Healthcare Medical Tester"},{"@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\/3015","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=3015"}],"version-history":[{"count":0,"href":"https:\/\/regask.com\/es\/wp-json\/wp\/v2\/posts\/3015\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/regask.com\/es\/wp-json\/wp\/v2\/media\/2484"}],"wp:attachment":[{"href":"https:\/\/regask.com\/es\/wp-json\/wp\/v2\/media?parent=3015"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/regask.com\/es\/wp-json\/wp\/v2\/categories?post=3015"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/regask.com\/es\/wp-json\/wp\/v2\/tags?post=3015"}],"curies":[{"name":"Gracias","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}